#computer system validation gmp

[zenovelsworld]

Ensure GMP compliance in your Indore pharmaceutical operations with Zenovel's expert Computer System Validation (CSV) services. We help you validate your critical systems for data integrity and regulatory adherence.

[communicationblogs]

Process Control Automation Market

📌 𝐌𝐚𝐫𝐤𝐞𝐭 𝐎𝐮𝐭𝐥𝐨𝐨𝐤

The Process Control Automation Market is set to surge from $108.6B in 2024 to $83.66T by 2031, driven by a steady CAGR of 3.8%. As industries strive for operational efficiency and reduced downtime, process automation is becoming a critical pillar of industrial competitiveness and resilience.

🔗 𝐆𝐞𝐭 𝐑𝐎𝐈-𝐟𝐨𝐜𝐮𝐬𝐞𝐝 𝐢𝐧𝐬𝐢𝐠𝐡𝐭𝐬 𝐟𝐨𝐫 𝟐𝟎𝟐𝟓-𝟐𝟎𝟑𝟏 → 𝐃𝐨𝐰𝐧𝐥𝐨𝐚𝐝 𝐍𝐨𝐰

📊 𝐓𝐨𝐩 𝐆𝐫𝐨𝐰𝐭𝐡 𝐕𝐞𝐫𝐭𝐢𝐜𝐚𝐥𝐬

• Oil & Gas — Refinery automation and predictive maintenance

• Chemicals — Batch control and compliance monitoring

• Food & Beverage — Consistent quality and safety assurance

• Pharmaceuticals — Stringent GMP controls and digital validation

• Power Generation — SCADA and remote plant management

💡 𝐖𝐡𝐚𝐭’𝐬 𝐏𝐨𝐰𝐞𝐫𝐢𝐧𝐠 𝐭𝐡𝐞 𝐌𝐚𝐫𝐤𝐞𝐭

• Industry 4.0 and digitization across heavy industries

• Real-time data analytics and IIoT sensor networks

• Need for precision and consistency in regulated sectors

• Cost and energy optimization goals amid rising input prices

🛑 𝐂𝐡𝐚𝐥𝐥𝐞𝐧𝐠𝐞𝐬 𝐭𝐨 𝐖𝐚𝐭𝐜𝐡

• Complex integration with legacy infrastructure

• Cybersecurity risks in SCADA and PLC environments

• Skilled labor shortages for advanced automation systems

🔬 𝐄𝐦𝐞𝐫𝐠𝐢𝐧𝐠 𝐓𝐫𝐞𝐧𝐝𝐬

• AI-enhanced process control and anomaly detection

• Edge computing for on-site data processing

• Cloud-based SCADA and decentralized control systems

• Sustainability-focused automation (waste, emissions, energy)

🏆 𝐊𝐞𝐲 𝐏𝐥𝐚𝐲𝐞𝐫𝐬 𝐭𝐨 𝐖𝐚𝐭𝐜𝐡

• Leaders: Siemens, Honeywell., Emerson.

• Innovators: FogHorn Systems, Inc, Braincube, Canary Labs, Seeq Corporation

• Regional: Yokogawa, Rockwell Automation, Schneider Electric

📈 𝐖𝐡𝐲 𝐈𝐭 𝐌𝐚𝐭𝐭𝐞𝐫𝐬

In today’s volatile industrial landscape, process control automation is the linchpin of agility, safety, and scalability. With global pressures to reduce waste, boost output, and comply with ESG standards, automation is not optional — it’s urgent.

#ProcessAutomation #SCADA #IIoT #SmartManufacturing #OperationalExcellence #DigitalTransformation #EdgeComputing #AIinIndustry #SustainableManufacturing #IndustryARC #IndustrialAutomation

[ascentemirates]

GMP Consultants: Integrating with Data Integrity and Computer System Validation

In today’s heavily regulated industries, Good Manufacturing Practice (GMP) certification is an indispensable element in delivering products that are consistently produced and controlled to quality standards. GMP is also essential for industries such as pharmaceuticals, biotechnology, food, and cosmetics to protect public health.

Meanwhile, the need for Data Integrity (DI) and Computer System Validation (CSV) is becoming a standard around the world. Regulatory authorities such as the FDA, EMA, and MHRA are looking for more than just good manufacturing, they're looking for credible, reliable data that supports product quality.

That is, when GMP Certification in UAE objectives are coupled with Data Integrity and CSV programs, it buttons up the entire compliance program, increases operational effectiveness, and establishes higher level of trust with the consumers and regulators.

What is GMP Certification?

GMP is proof that the manufacturer has followed specific guidelines for high quality, safety, and efficacy. Those standards pertain to every aspect of your production, from raw materials to human hygiene, down to equipment cleaning and documentation.

Industries that Require GMP

The certification is a must for various sectors such as:

Biopharmaceuticals and biotechnology

Medical devices

Cosmetics and personal care

Food and beverages

Nutraceutical and food supplements

Fundamental Aspects of GMP Regulations

These standards are concentrated on several key points:

Good and well-maintained factory formats

Written instructions and procedures have been given and followed

Correct documentation of manufacturing parameters

Competent and trained personnel

Quality control and complaint management systems

Following these principles will also result in the quality of products being produced and controlled to standards suitable for their intended use.

Responsibility of GMP Certification Consultants

What Are GMP Consultants?

GMP Consultants are professionals who specialize in assisting companies through the GMP obligations maze. They deliver personalized guidance to help meet compliance, pass audits, and stay certified long-term.

Services Offered:

Gap Analysis and Audits (GA&A): Highlighting non-compliance areas and suggesting optimal improvements.

Development of QMS: Layout of systems and procedures in compliance with GMP.

Employee Training and Inner Audits: Training of the staff and enhancement of already established internal audit procedures.

External Certification Audit Preparation: Assisting businesses to prepare for 3rd party audits by certification bodies or regulators.

Advantages of Using Consultants:

Bringing in consultants, you can expect that when companies bring in GMP Certification Consultants, they bring in added value

Industry-specific know-how

Quicker and more streamlined certification timelines

Increased confidence in adhering to and maintaining adherence

Data Integrity and CSV: An Introduction to CSV

What is Data Integrity?

Data Integrity (DI) is about the accuracy, completeness, consistency, and reliability of data during its lifetime. Regulatory agencies insist that all records, including electronic and paper-based records, be subject to the most rigorous level of integrity.

Principles of ALCOA+

ALCOA+ – the basics of data integrity. Since the days of GCP, the principles of data quality have rested on these 6 basic principles:

Attributable: The data should be linked to the person who created it.

Readable: Data shall be capable of being read and maintained.

Contiguous Florentines: Information should be entered promptly into the log from the time of the activity.

Original: The original records should be retained.

Accurate: Data should be representative of what actually occurred.

Plus: Comprehensive, Coherent, Permanent, and Accessible.”

What is CSV?

Computer System Validation (CSV) Computer system validation ensures that a computerized system employed in these regulated activities is able to generate a result that meets its predetermined specifications. CSV ensures that a system works as intended and in accordance with the standard.

Data Integrity, CSV, and GMP Compliance

Why Compliance Relies on Data Integrity?

Without integrity, quality and safety can not be assured. Data Integrity concerns have been taking center stage during regulatory inspections, and in the event of a breakdown, you may end up with warning letters, product recalls, as well as facility shutdowns.

Utilization of Validated Computer Systems for Operations

Computer systems are validated to ensure that:

The data are obtained with high accuracy and repeatability.

Regulatory and business requirements are satisfied by system functions.

Electronic saved records are reliable and auditable.

Advisor Integration Strategies:

DI Risk Assessments and Gap Analysis: Locating the weak spots in data processing and solutions to remedy them.

Validator Master Plans (VMP) Computer Systems: Defining the validation approach, activities, and documentation that will be needed.

Audit Trails, Access Controls, and Electronic Record Management: Appropriate tracking, safeguarding, and managing access to the information across the systems.

Certification and Validation with Consultant Support

The Initial Review of Systems and Practices

The GMP Certification Consultants in Dubai start with a complete examination of existing manufacturing and data management systems with regard to GMP, DI, and CSV requirements.

Planning of Remediation for DI Gaps and Validation Gaps

Corrective action plans are developed following gap analysis, focusing on the highest risk exposure to compliance and product quality.

System Compliance to Requirements (GAMP 5 approach, where applicable)

In accordance with GAMP 5 (Good Automated Manufacturing Practice) principles, the consultation team heads validation activities, providing a risk-based, scalable approach for computer system validation.

Documentation: SOP and Validation Reports Preparation

SOPs, URS, Validation Protocols (IQ, OQ, PQ), and final Validation reports are also developed to show all aspects of compliance.

Training on DI, CSV Principles

The GMP Certification in UAE experts provide various training programs to sensitize and enhance the knowledge of the workforce with regard to Data Integrity and Computer System Validation.

Final Audits and Ongoing Monitoring Measures

A last internal audit declares the company prepared for external audits, and long-term compliance is supported by enforced monitoring schedules.

Challenges in Integration

Legacy System Compliance/Remediation

Systems that are not validated and are older can represent a serious threat to the integrity of data. Replacing these legacy systems to bring them up to code takes time and money.

Adapting to Changing Regulatory Requirements

Regulatory recommendations about DI and CSV are constantly changing. Enterprises need to be aware of and adjust to changing standards in order to stay compliant.

Resource and Knowledge Constraints in SMEs

Some socioeconomic, small and medium-sized enterprises (SMEs) have limited data capability and resources. This makes working with external GMP Consultants in Abu Dhabi all the more important to ensure that you’re both reaching and maintaining compliance.

Future Trends

Emergence of Digital Validation Tool

By automating the validation, CSV tasks are getting faster, and manual activities are decreased, while concessions, accuracy, and audit preparation are improved!

Growing Use of Cloud-Based Platforms and DI Exposure

Although cloud systems bring convenience, economy, and scalability, they also lead to new data security and integrity problems. However, validation and vendor management take on critical importance.

More Regulatory Attention on AI and New Technologies under the Settings

Regulators are likely to issue new guidelines on validating these advanced technologies as artificial intelligence and machine learning enter regulated businesses.

The Main Point!!

Combining the certification, Data Integrity, and Computer Systems Validation is not an option anymore; they are mandatory for any company working in a highly regulated environment. This alignment will not only reinforce compliance but also enhance operational performance, product quality, and consumer confidence.

Through engaging with Good Manufacturing Practice experts, businesses receive the knowledge and structured support required to navigate the intricacies of regulatory environments.

GMP Consultants in UAE assist companies in putting in place strong systems that deliver continued compliance and future success in a very challenging global market.

[gxp-auditing-blog]

Enhancing Your Organization with GxP Compliance: A Comprehensive Guide to GxP Auditing and Risk Assessment

A well-structured GxP compliance checklist can significantly benefit your organization. To use it effectively, it’s essential to first understand the term "GxP," an abbreviation for "Good Practice."

As a term, "GxP" can appear broad and vague, leaving businesses uncertain about the quality guidelines and regulations they must adhere to. The “x” in GxP is a variable, representing different fields such as "L" for Laboratory, "A" for Agricultural, "T" for Tissue, "D" for Distribution, and more.

Given its broad applicability across various industries, it’s vital to delve into what GxP compliance entails, ensuring your business meets essential quality standards. Below, we’ll explore the principles of GxP, the importance of GxP auditing, and a risk assessment-driven compliance checklist to help you navigate this essential framework.

Understanding GxP Compliance

GxP serves as a foundation to ensure the integrity, safety, and quality of products and services delivered to customers. It involves traceable, accountable policies, processes, and procedures. Core questions include:

Can you trace the development of your products end-to-end?

Do you have visibility into who contributed to product development and how?

At its heart, GxP compliance emphasizes traceability and accountability—cornerstones for building more specific quality frameworks like GDP (Good Distribution Practice), GMP (Good Manufacturing Practice), or GTP (Good Tissue Practice).

The Importance of GxP Auditing and Risk Assessment

GxP auditing plays a crucial role in ensuring compliance, helping organizations identify gaps and areas for improvement. Additionally, conducting a GxP risk assessment allows businesses to proactively manage potential risks in processes, systems, and products. This dual approach minimizes operational disruptions while maintaining regulatory alignment.

GxP Compliance Checklist

Use this checklist to evaluate your organization’s GxP compliance. If you answer "yes" to each question, your organization has a strong compliance foundation.

Documentation

Do we have a functional document control system in place?

Is there a secure repository for storing live and archived documents?

Are document changes audit-trailed with clear version controls?

Do we have policies for document retention, security, and archiving?

Equipment

Is there a documented process for validating and qualifying equipment?

Do we maintain a centralized equipment inventory with manuals?

Are equipment calibration and maintenance schedules documented and adhered to?

Are logs of maintenance and calibration events securely stored?

Processes & Procedures

Do we maintain a central listing of all active Standard Operating Procedures (SOPs)?

Are SOPs reviewed regularly to ensure they remain relevant and compliant?

Is there a documented change control process for SOP amendments?

Are deviations and corrective actions (CAPAs) thoroughly documented?

People

Are all employees trained and competent in their roles?

Is there a documented training plan and record for each employee?

Do we have an accurate organizational chart and a dedicated quality department?

Can employees report issues, concerns, or near misses easily?

Environment, Health, and Safety (EHS)

Are facilities clean, maintained, and equipped with appropriate environmental controls?

Are safety equipment and PPE available and used correctly?

Do we have documented sanitation and waste disposal processes?

Information Security and Validation

Are computer systems secured with individual logins and regular backups?

Is there an information security policy in place?

Are software systems validated for their intended use?

Do we maintain records of system changes, maintenance, and incidents?

Leveraging Technology for GxP Compliance

Modern tools like Q-Pulse can simplify GxP compliance. With features like centralized document management, equipment tracking, process automation, and secure data storage, Q-Pulse ensures your organization meets GxP auditing and compliance requirements.

Final Thoughts

Achieving and maintaining GxP compliance is an ongoing process that requires diligence, regular auditing, and proactive risk assessment. By following a robust GxP compliance checklist, your organization can improve product quality, ensure regulatory adherence, and build trust with stakeholders.

Remember, GxP compliance is more than a regulatory obligation—it’s a commitment to delivering excellence in every aspect of your business.

[skillbesolution]

Pharmaceutical Computer System Validation and Regulatory Affairs Courses: Ensuring Compliance and Quality in the Pharmaceutical Industry

In the rapidly evolving landscape of the pharmaceutical industry, two critical areas have emerged as essential pillars for maintaining quality, safety, and regulatory compliance: Pharmaceutical Computer System Validation and Regulatory Affairs. These specialized fields play a crucial role in ensuring that pharmaceutical companies meet stringent regulatory requirements while leveraging cutting-edge technology to enhance their operations. In this comprehensive article, we will delve into the importance of these disciplines and explore the courses available for professionals seeking to excel in these areas.

The Significance of Pharmaceutical Computer System Validation

Pharmaceutical Computer system Validation (CSV) is a systematic process that verifies and documents that computer systems used in pharmaceutical manufacturing, quality control, and other regulated activities consistently perform as intended and meet predetermined specifications. This process is critical for ensuring the integrity, reliability, and accuracy of data generated by these systems.

Key Aspects of CSV

1. Risk Assessment: Identifying potential risks associated with computer systems and their impact on product quality and patient safety.

2. Requirements Specification: Clearly defining the functional and performance requirements of the system.

3. Design Qualification: Ensuring that the system design meets the specified requirements.

4. Installation Qualification: Verifying that the system is installed correctly and in accordance with specifications.

5. Operational Qualification: Demonstrating that the system operates as intended across its normal operating range.

6. Performance Qualification: Confirming that the system consistently meets performance criteria under actual operating conditions.

The Importance of CSV in Regulatory Compliance

Regulatory bodies such as the FDA and EMA require pharmaceutical companies to validate their computer systems to ensure data integrity and compliance with Good Manufacturing Practices (GMP). Failure to properly validate these systems can result in serious consequences, including regulatory actions, product recalls, and damage to a company's reputation.

Regulatory Affairs: Navigating the Complex Landscape of Pharmaceutical Regulations

Regulatory Affairs is a critical function within pharmaceutical companies that ensures compliance with laws, regulations, and guidelines governing the development, manufacturing, and marketing of pharmaceutical products. Professionals in this field serve as the bridge between pharmaceutical companies and regulatory authorities.

Key Responsibilities in Regulatory Affairs

1. Regulatory Strategy Development: Creating comprehensive strategies for product development and market entry that align with regulatory requirements.

2. Submission Preparation: Compiling and submitting regulatory dossiers, including New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs).

3. Compliance Monitoring: Ensuring ongoing compliance with regulatory requirements throughout a product's lifecycle.

4. Regulatory Intelligence: Staying informed about changes in regulations and their potential impact on the company's operations.

5. Liaison with Regulatory Authorities: Communicating with regulatory agencies and addressing their queries and concerns.

Pharmaceutical Computer System Validation Courses: Building Expertise in CSV

For professionals looking to specialize in Computer System Validation, several comprehensive courses are available:

1. Foundations of CSV

This introductory course covers:

• Basic principles of CSV

• Regulatory requirements and industry standards

• CSV lifecycle and documentation

2. Advanced CSV Methodologies

This course delves deeper into:

• Risk-based approach to CSV

• GAMP 5 guidelines

• Validation of cloud-based systems and software as a service (SaaS)

3. Data Integrity in Computerized Systems

Focusing on a critical aspect of CSV, this course covers:

• Data integrity principles (ALCOA+)

• Audit trail review and data governance

• Strategies for ensuring data reliability and security

4. CSV for Specific Systems

Specialized courses targeting validation of:

• Laboratory Information Management Systems (LIMS)

• Manufacturing Execution Systems (MES)

• Electronic Quality Management Systems (eQMS)

Regulatory Affairs Courses: Developing Expertise in Pharmaceutical Regulations

For those pursuing a career in Regulatory Affairs, the following regulatory affairs courses offer comprehensive knowledge and skills:

1. Introduction to Pharmaceutical Regulatory Affairs

This foundational course covers:

• Overview of global regulatory frameworks

• Key regulatory agencies and their roles

• Basics of drug development and approval processes

2. Regulatory Strategy and Drug Development

An advanced course focusing on:

• Developing regulatory strategies for drug development

• Clinical trial regulations and good clinical practices (GCP)

• Expedited regulatory pathways and special designations

3. Regulatory Submissions and Dossier Preparation

This hands-on course covers:

• Common Technical Document (CTD) format

• Electronic submissions (eCTD)

• Best practices for preparing high-quality regulatory submissions

4. Post-Marketing Regulatory Requirements

Focusing on the product lifecycle, this course includes:

• Pharmacovigilance and safety reporting

• Post-approval changes and variations

• Product lifecycle management from a regulatory perspective

Conclusion: Empowering Pharmaceutical Professionals

Pharmaceutical Computer System Validation and Regulatory Affairs courses offer invaluable knowledge and skills for professionals looking to make a significant impact in the pharmaceutical industry. By mastering these disciplines, individuals can play a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products while navigating the complex regulatory environment.

[sudheervanguri]

Currently, Amneal Pharmaceuticals is hiring at its injectable plant in SEZ-Matoda. We have exciting career possibilities in Quality Assurance, Environmental Monitoring, and Engineering. If you have a degree in B.Pharma/M.Pharma, BSc./M.Sc. (Microbiology), or B.E./B.Tech, join one of the most dynamic groups in the pharmaceutical sector. 1. Quality Assurance (QA) - Injectable/Parental Department Designation: Deputy Manager / Manager - QA Qualification: B.Pharma / M.Pharma Experience: 10 to 15 years in an injectable/sterile production plant Key Responsibilities: Reviewing audit trail observations and justifications. Preparing and tracking Annual Product Quality Review (APQR) schedules. Reviewing gadget qualification reviews for Computer System Validation (CSV). Conducting threat assessments for equipment and systems. 2. Quality Assurance - Environmental Monitoring (Microbiologist) Designation: Trainee/Officer/Sr. Officer/Executive/Sr. Executive Qualification: B.Sc. (Micro) / M.Sc. (Micro) / B. Tech. (Biotech) / M. Tech (Biotech) Experience: 2 to 6 years in an injectable/sterile manufacturing plant Key Responsibilities: Monitoring the cleanroom environment within manufacturing areas. Conducting non-feasible particle monitoring. Maintaining environmental tracking information. 3. Project & Engineering Department (Injectable/Parental) Designation: Deputy Manager / Manager / Senior Manager (Plant Maintenance). Qualification: B.E. / B.Tech Experience: 10 to 18 years in an injectable/sterile manufacturing plant Key Responsibilities: Handling equipment preventive maintenance. Ensuring compliance with GMP regulations. Preparing for and handling regulatory audits. Why join Amneal Pharmaceuticals? Meaningful Impact: Help produce pleasant prescription drugs while maintaining sustainability. Career Growth: Take advantage of the learning and development possibilities. Supportive Team: Join a collaborative subculture that values variety and innovation. How to Apply: Interested candidates can contact us via ajaykumar.Pandey@amneal.Com or jigar.Khambhala@amneal.Com. [caption id="attachment_49554" align="aligncenter" width="930"] amneal pharmaceuticals recruitment notification[/caption] Disclaimer: Amneal Pharmaceuticals does not rate applicants or authorize agencies to collect recruitment charges.

[imageprovision]

Proofreading software for pharmacy

What is Proofreading?

Proofreading, at its core, is the art of meticulously examining content to catch errors, ensuring it's polished and error-free. It's like being the vigilant guardian of written documents, preventing embarrassing typos, and ensuring clarity.

The role of pharmaceutical artwork proofreading is pivotal in maintaining the integrity of pharmaceutical products. Whether through the meticulous eyes of a human proofreader or the efficiency of automated systems, the goal remains the same  precision that safeguards both regulatory compliance and patient well-being. As we navigate the future, the synergy of human and machine capabilities promises a new era of accuracy in pharma artwork proofreading.

1. Pre-press Proofreading: Pre-press proofreading is a crucial step in the production of printed materials in the pharmaceutical industry. It involves a thorough review of content, graphics, and layout before mass production to ensure accuracy and prevent errors.

2. FDA Guidelines: The FDA, or U.S. Food and Drug Administration, establishes guidelines and standards for the pharmaceutical industry. Companies must adhere to these guidelines to ensure the safety, efficacy, and quality of drugs and medical products throughout their development and manufacturing processes.

3. Incoming Material Inspection: Incoming material inspection is a quality control process where raw materials or components for pharmaceutical manufacturing are carefully examined upon arrival. This step ensures that materials meet specified quality standards and are suitable for use in the production process, preventing the use of substandard or contaminated materials.

4. Manufacturing Practices in Pharma: Good Manufacturing Practices (GMP) are regulations and standards that ensure consistent production and quality of pharmaceutical products. Adhering to GMP is essential for manufacturers to meet regulatory requirements and produce safe and effective drugs. GMP covers aspects such as facility cleanliness, equipment calibration, process validation, and personnel training.

What is Manual Proofreading?

In the not-so-distant past, proofreading was a manual affair. Manual proofreading involved eagle-eyed individuals poring over documents, hunting for elusive mistakes. It was a labour-intensive process, akin to searching for a needle in a haystack.

Manual proofreading has been the backbone of quality assurance in the pharmaceutical industry. However, it comes with its own set of challenges, including time-consuming processes and resource-intensive workflows.

What is Automated Proofreading?

Fast forward to today, and we have the marvel of the automatic proofreader or electronic proofreader. Imagine a digital assistant with a magnifying glass scanning documents at lightning speed. The role of automation in pharma artwork proofreading has revolutionised the game, bringing efficiency and accuracy to new heights. Automation has emerged as a game-changer in pharma artwork proofreading. 

Automatic proofreader refers to the use of technology, such as software and algorithms, to identify and correct errors in written content. This method relies on computer programmes that are designed to analyse and do global vision print inspection.

Automation introduces speed into the pharma artwork proofreading process, enabling the swift analysis of large volumes of artwork. An automated proofreading machine will ensure that every piece of artwork is evaluated with the same level of scrutiny, eliminating the variability inherent in manual processes.

ipvProofCheck is a cutting-edge solution that revolutionises the identification process through pixel-to-pixel comparison for carton, leaflet, and label analysis. The system sorts deviations using advanced algorithms that give an unmatched level of accuracy and make it clear whether a deviation is accepted, not accepted, or still needs to be handled. This system stands out as a 21CFR Part 11-compliant solution, adhering to stringent regulatory standards. 

Embedded within ipvProofCheck is an in-built algorithm designed for efficient proofreading of documents. It is capable of identifying nuanced issues such as character shifts, colour changes, and the absence or presence of characters. The system's pixel-to-pixel comparison methodology enables it to capture even minute discrepancies. 

Similarly, ipvPSA ensures quality control in labs. It is microscopic particle size analyser with a wide range of benefits. 

Stock Keeping Unit (SKU)

Stock-keeping Keeping Unit refers to a unique identifier assigned to each distinct product or variant in inventory management. In the pharmaceutical industry, SKUs are assigned to different drug formulations, strengths, and packaging configurations. Automation aids in SKU management during artwork proofreading by ensuring that the correct SKU information is accurately reflected in the artwork. This helps prevent packaging errors and ensures that the right product information is associated with the corresponding SKU. Automated systems can cross-verify SKU details, reducing the likelihood of discrepancies.

AstraZeneca

AstraZeneca is a multinational pharmaceutical company known for developing and manufacturing a wide range of pharmaceutical products, including vaccines such as those for COVID-19. In the context of AstraZeneca and pharmaceutical artwork proofreading, automation can enhance efficiency and accuracy. 

Automated proofreading tools can assist in reviewing and validating the content of packaging materials, ensuring that they align with AstraZeneca's branding guidelines, regulatory requirements, and specific product information.

Good Manufacturing Practices (GMP)

Good Manufacturing Practices are essential in the pharmaceutical industry to ensure the quality, safety, and efficacy of medicinal products. GMP guidelines provide a framework for manufacturing processes, including artwork creation and proofreading. Automation can play a crucial role in adhering to GMP standards during artwork proofreading. 

Automated systems can help in maintaining consistency, accuracy, and compliance with regulatory requirements. They can streamline the proofreading process, reducing the risk of errors and ensuring that the final artwork aligns with GMP standards.

Manual vs. Automated Proofreading

Let's pit the old against the new in a friendly face-off: manual vs. automated proofreading. While manual proofreading relies on human scrutiny and intuition, automated proofreading is all about algorithms and artificial intelligence. It's not a battle of superiority but a collaboration for perfection.

Manual Proofreading

Manual proofreading has been the stalwart guardian of written content for generations. It involves the meticulous scrutiny of documents by human eyes and intellect. The process is akin to a skilled artisan crafting a masterpiece, with each word and punctuation mark receiving personal attention.

Advantages of Manual Proofreading

1. Personalised Attention: The human touch adds a level of understanding and nuance that machines may struggle to grasp. Manual proofreaders can interpret context, ensuring that the intended meaning is preserved.

2. Contextual Awareness: Humans bring a wealth of contextual understanding to the table. This is particularly crucial in pharmaceutical artwork, where precision and clarity are paramount.

3. Emotional Intelligence: Understanding the emotion behind the words is uniquely human. Manual proofreading can discern the tone and intent, ensuring that the content resonates appropriately.

Challenges of Manual Proofreading

1. Time-Consuming: Manual proofreading is a time-intensive process. In industries like pharma, where time is often of the essence, this can be a limiting factor.

2. Prone to Human Error: Despite the best efforts, humans are fallible. Fatigue or distractions can lead to oversights, and the margin for error exists.

Automated Proofreading

Enter the era of automated proofreading, where algorithms and artificial intelligence take centre stage. Automation brings speed, efficiency, and a different kind of accuracy to the proofreading process.

Advantages of Automated Proofreading

1. Speed and Efficiency: Automation can scan through large volumes of content at a speed that humans can't match. This is a significant advantage in industries like pharma, where time is often critical.

2. Consistency: Machines are consistent in their approach. They don't get tired, ensuring that every instance of proofreading is approached with the same level of scrutiny.

3. Scalability: Automated systems can handle vast amounts of data simultaneously, making them scalable for the demands of the pharmaceutical industry.

Challenges of Automated Proofreading

1. Lack of Contextual Understanding: While algorithms excel in pattern recognition, they might struggle with the nuanced understanding of context that a human brain possesses.

2. Inability to Detect Certain Errors: Some errors, especially those related to context or subtle language nuances, may elude automated systems.

[seminarsworld]

Trends in FDA Compliance and Enforcement for Regulated Computer Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed.

 This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

Why should you attend

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and signatures, as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. This guidance has been modified over the years to make it more palatable to industry, and this includes discretionary enforcement measures. The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.

This session will provide some insight into current trends in compliance seminars and enforcement. Some are based on technology changes, and these will continue to have an impact as new innovations come into use in the industry.

Webinar Takeaway

Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology

Understand “GxP” Systems

Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)

Learn how Data Archival plays a key role in ensuring security, integrity and compliance

Learn how to develop a solid Validation Strategy that will take into account the system risk assessment and system categorization (GAMP V) processes

Learn about recent FDA regulatory training and  for companies in regulated industries

Learn about recent trends in technology that need to be addressed in the CSV approach

Q&A

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Who will benefit

Professionals in the following industries may also benefit from the content:

Pharmaceutical

Medical Device

Biotechnology

Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)

Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm

Information technology managers and analysts

QC/QA managers and analysts

Clinical data managers and scientists

Compliance managers

Lab managers and staff

Automation analysts

Computer system validation specialists

GMP training specialists

Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, and audit

Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance

Anyone involved in the planning, execution, and reporting of a clinical trial (sponsor, director, researcher, regulatory role, etc.)

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

[pnovick]

IT / OT SPECIALIZED APPLICATIONS LEAD - 202302-104997 Location: Oceanside, California

Industry: Pharmaceutical / Biotech Job Category: Information Technology - Other IT Are you passionate about Information (IT) and Automation Technology (OT) and aspiring to make a meaningful impact? Are you curious to shape a digital manufacturing architecture, ready to advance competitiveness on the market? We Make Medicines!​ ​Behind every product sold by the company​ is Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes lifesaving medicines at 11 locations, with the support of partners from around the world. Information (IT) and Automation Technology (OT) teams are key in producing and delivering medicine to patients. The organization is currently transforming towards digitalization, advancing fundamental elements to meet future needs, such as using new technologies. We are looking for a highly motivated engineer to take on the role of IT / OT Specialized Application Lead as part of the Site IT / OT Organization in a 24x7 Good Manufacturing Practice (GMP) environment. The successful candidate will be: Site Owner of “Customized Applications” that interface with Manufacturing System Platforms such as OSI PI (Plant Historian), Syncade (MES), DeltaV (Distributed Control System), PLC's, Lab Data Systems (Smartline Data Cockpit) using OPC or other middleware. Examples of custom applications include: reports/reporting tools, dashboards Skilled at scripting and programming preferably in a manufacturing systems environment (Java, C++, Python, PowerShell) Support Lead for custom applications but also knowledgeable in Operational Technology Systems May eventually expand the role to become a Regional role for multiple sites supporting IT / OT operating model evolution What you will be working on: Development and Lifecycle management of the customized applications and related systems Support the implementation of OT standards and best practices across all sites Support commissioning and startup activity of new process control systems and manufacturing systems (Syncade, DeltaV, PLC’s, OSI PI historian, etc.) Support the execution of computer system validation and control system lifecycle management Develop and maintain GMP/Non-GMP design documentation and engineering diagrams Execute testing and installation of system/database patches, upgrades, and new releases Troubleshoot and resolve incidents and problems associated with the system/databases and applications Execute implementation and delivery of projects on-site IT OT Product Portfolio Operate and execute change control process for system deployment and release management of system/database software across Good Manufacturing Practice (GMP) validated and non-GMP environments Requirements / Qualifications: Bachelor’s degree in Engineering, Computer Science, or equivalent experience A minimum of 5 years systems engineer experience involved in the design, implementation, and/or support of automation systems, preferably in a regulated (Pharmaceutical) industry. Candidates with 8-10 years of relevant experience are preferred. 24X7 support, participate in an on-call environment to meet business continuity requirements, including weekends and holidays as required Extensive experience with scripting and programming in various languages (Java, C++, Python, PowerShell) preferably in a Manufacturing Systems environment Experience with scripting and programming in various languages (Java, C++, Python, PowerShell) Experience with Microsoft Windows Server operating system, Microsoft SQL Server, and development tools Experience with Emerson DCS DeltaV, MES Syncade, OSIsoft PI, Rockwell Automation AssetCentre, and various OPC architectures Onsite at Oceanside, CA, required (no remote) Relocation assistance will be considered for exceptional candidates Security Clearance Required: No Visa Candidate Considered: No Read the full article

[gmpsop12]

computer systems validation

[gxpcellators-canada]

Mastering Computer System Validation: The Expertise of Consultants in Canada

Computer system validation is a vital aspect of pharmaceutical manufacturing, as it ensures that the hi-tech systems used in the production process meet regulatory requirements for accuracy, consistency, and reliability. For pharmaceutical companies in Canada, the complexities of the validation process can be immense, and that's where computer system validation consultants in Canada come in. Let's delve a bit into how computer system validation consultants help pharmaceutical companies in Canada, and why consultant companies like GxP Cellators are so useful for keeping your computer systems up-to-date with the industry standards.

How do computer system validation consultants help pharmaceutical companies in Canada?

Computer system validation consultants in Canada possess immense prowess in the regulatory landscape of the pharmaceutical industry. They have a nuanced understanding of the regulations and requirements surrounding computer system validation and can ably provide expert guidance and advice to pharmaceutical companies looking forward to validate their computer systems.

One of the key ways that computer system validation consultants in Canada assist pharmaceutical companies is by providing support and guidance throughout the validation process. They work closely with companies to gain insight on their unique needs and requirements, and to curate a validation strategy that meets regulatory requirements while also being cost-effective and efficient.

All in all, Computer system validation consultants in Canada provide valuable assistance to companies in ensuring that their computer systems are up-to-date with a number of regulatory requirements that apply to pharmaceutical manufacturing. They guide companies in navigating through complex regulations such as GMP, GAMP, and 21 CFR Part 11, and provide assistance on the various techniques which can be used to meet their numerous requirements. They help companies ensure proper compliance with various regulatory requirements which are up-to-date with the latest changes, while also ensuring that the validation process is efficient, understandable and cost-effective.

GxP Cellators: the one-stop shop for all your computer system validation needs

Looking for a CSV consultants in Canada to help your pharmaceutical company validate its computer systems? Look no further than GxP Cellators, which strives to be the one-stop shop for all your needs. GxP Cellators hosts a team of seasoned validation consultants who specialize in assisting pharmaceutical companies in the validation of their computer systems in accordance with the latest regulatory orders and policies in Canada.

The GxP Cellators team has a profound and comprehensive knowledge of the regulatory landscape surrounding computer system validation in the pharmaceutical industry in Canada. They have extensive hands-on experience working with pharmaceutical firms of all sizes and are committed to providing validation solutions that are cost-effective, yet highly efficient no matter where your firm stands in Canada.

In addition to providing support and guidance throughout the validation process, GxP Cellators can also help companies develop and implement compliant processes and procedures. They can conduct audits and assessments to identify areas of non-compliance and make recommendations for corrective action. They can also provide training and education to ensure that employees understand their roles and responsibilities in maintaining compliance.

Overall, GxP Cellators is the ultimate destination for all the computer system validation needs your pharma company has in Canada. They have the expertise and experience to help your pharmaceutical company achieve its validation goals, while also ensuring compliance with regulatory requirements. So wait no more. Go to gxpcellators.com and get in touch with some of the finest consultants in the business that will take your computer systems to the next level.

Conclusion

Computer system validation consultants in Canada play an immensely important role in helping pharmaceutical companies validate their computer systems in compliance with up-to-date regulatory requirements. They provide expert guidance and support through the entire validation process, while also ensuring that it is light on your pocket. GxP Cellators is the one-stop shop for all your computer system validation needs in Canada. They have the expertise and experience to help your pharmaceutical company achieve its validation goals, while also ensuring compliance with regulatory requirements. If you're looking for a computer system validation consultant in Canada, GxP Cellators is an ideal choice.

[clininfotech0]

Pharma CSV course Online

Regulatory organisations want computer system validation (CSV) to ensure that a computerised system continuously performs as intended. CSV is a multi-step process. Every time you modify the system or software, you must evaluate revalidation, then record these actions and any test outcomes related to the modification.

CSV can be expensive and time-consuming, especially if you're validating on paper and haven't used a risk-based strategy to identify the right amount of testing and documentation needed to satisfy regulatory requirements. CSV is best suited for high-risk systems that directly affect patient safety or product quality because to its complexity. Computer Software Assurance (CSA), a streamlined technique for doing CSV, can lower project costs and shorten time to market if a system is judged to be low- to medium-risk. Unfortunately, any possible efficiency advantages using CSA will be lost if you validate on paper.

The transition to a paperless, automated validation lifecycle management system like ValGenesis can lessen your validation burden and enable you to save a significant amount of time, money, and effort, regardless of whether you choose to use the conventional CSV methodology or the more contemporary, streamlined CSA approach.

CSV first and foremost avoids software malfunction, but more importantly, it is required by law!

The need to ensure that these technologies are accurate and safe for patients and end users is growing as the pharmaceutical and life sciences industries modernise and use more technology.

A defined procedure called CSV ensures that a computer system performs as it is intended to.

Guidelines for CSV procedures have been created by the Food & Drug Administration (FDA) and the European Medicines Agency (EMA).

Utilizing software and technology from the life sciences for CSV has two primary benefits:

Before a software issue affects the usage environment, CSV can stop it. Computer systems that aren't functioning properly might have major negative effects on the patient, especially in the context of clinical trials. This can then result in legal action, penalties, or a closure.

It might be illegal to carry out some computer system validations without following best practises. Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices are governed by EMA and FDA norms and regulations (GCP).

By harmonising its CSV standards with international norms like ISO 9000:2000, the FDA hopes to strengthen them.

In order to bring Good Practice Quality Guidelines (GxP) to the IT environment, the Good Automated Manufacturing Processes (GAMP) initiative was created.

FDA rules vary depending on the type of software being validated (off-the-shelf, configurable, or bespoke software), as well as commercial and compliance concerns, and "retrospective" validation for older systems that have never been validated.

The EMA updated its CSV recommendations, which cover themes including spreadsheet specifications, database security, risk management, retrospective validation, how long electronic data and documents should be stored, and validation for mobile devices.

The most recent CSV validation rules are available on the EMA website.

It is necessary for electronic records and electronic signatures to adhere to 21 CFR Part 11.

As the FDA mandates the validation of all computerised systems with GxP electronic data, CSV becomes crucial.

The life sciences sector is proactive in verifying systems that provide accurate, secure documents and audit trails that are time-stamped in accordance with 21 CFR Part 11.

Choosing the Pharma CSV course Online will give you immense knowledge in this field and is also the right step for a fulfilling career. 

[mikesassa]

Quality Assurance System Implementation

The difference between Quality Control (QC) and Quality Assurance (QA) is not always clear. Quality Control refers to the process that analyzes every raw material, excipient, intermediate material and finished product, in the laboratory.  Quality Assurance is a complex system that includes: Site Master File (SMF), Quality Manual (QM), Main SOPs, Equipment Validation, Process Validation, Cleaning Validation, Computer System Validation, Product Quality Review, Risk Analysis, Audits and Inspections.

[nacptpharma-blog]

13 Important Benefits of Cannabis Validation

Cannabis corporate training to cannabis employers on all major areas of validation: Specialized corporate training can be done for all types of validation: Process Performance Qualification, System Validation includes Facility, Utility, Equipment and Computer Validation, Cleaning Validation, Testing Method Validation, Packaging Components Validation, and other related validation. Most of the corporate training can be offered via on-line or on-campus training for a group of employees.

Benefits of Validation

1)      Demonstrate consistency in the process and systems

2)      Public safety

3)      Comply with regulatory requirements

4)      Quality Assurance

5)      Minimize noncompliance work

6)      Avoid Failures

7)      Reduce batch rejection

8)      Avoid recalls

9)      Avoid reworks

10)  Corporate image

11)  Legal protection

12)  Protect third party contract

13)  Increase revenue for long run

Types of Cannabis Validation

Corporate Training: Cannabis Quality Control Testing Method Validation

AS per GPP requirements, all cannabis analytical testing methods is a mandatory validated. Cannabis testing methods needs to validated as per Health Canada’s GPP, European Good Manufacturing Practices (EU-GMP) regulatory requirements and industrial standards. Test methods validation includes assay for cannabinoids potency, residual solvents, contaminations which includes heavy metals, pesticides, foreign materials, extraneous substances, dissolution, disintegration, microbiological content, toxins and etc.

Corporate Training: Other Types of Validation

It is highly recommended for Cannabis Corporate Training industry to validate their production processes which includes cultivation, processing and packaging processes as well as systems which includes facility, utility, equipment, computer and instrument qualifications.

Aspirants who want to become Validation Specialists, Validation Assistant, Validation Scientist, Validation Engineer, Validation Technologists should attend the cannabis validation corporate training to understand and implement validation techniques within their processes and systems.

[gxp-auditing-blog]

Different Types of GxP Services

GxP services in the UK encompass various quality and compliance practices designed to ensure that life sciences organizations, including pharmaceutical, biotechnology, and medical device companies, adhere to strict regulatory requirements. GxP stands for Good [X] Practice, where "X" can represent different areas of focus. Below are the common types of GxP services offered in the UK:

1. Good Manufacturing Practice (GMP)

Focuses on ensuring the quality and safety of products during manufacturing processes.

Includes services like GMP audits, validation of manufacturing processes, equipment qualification, and batch record review.

2. Good Laboratory Practice (GLP)

Ensures the quality and integrity of non-clinical laboratory testing data.

Covers services such as laboratory audits, SOP development, and training on GLP compliance.

3. Good Clinical Practice (GCP)

Maintains ethical and scientific quality standards for designing, conducting, and reporting clinical trials.

Services include GCP audits, clinical trial monitoring, and regulatory compliance support.

4. Good Distribution Practice (GDP)

Focuses on ensuring the quality of pharmaceutical products during storage and distribution.

Services include supply chain audits, temperature-controlled logistics validation, and GDP training.

5. Good Pharmacovigilance Practice (GVP)

Relates to monitoring the safety of medicines and managing adverse drug reactions.

Services include pharmacovigilance audits, risk management plan development, and compliance monitoring.

6. Good Documentation Practice (GDP) (distinct from Good Distribution Practice)

Refers to maintaining accurate and consistent documentation across processes.

Services include document control system setup, record management, and training on documentation standards.

7. Good Automated Manufacturing Practice (GAMP)

Focuses on the use of automated systems in manufacturing processes to ensure compliance.

Services include computer system validation (CSV), software qualification, and risk assessments.

8. Good Clinical Laboratory Practice (GCLP)

Combines aspects of GLP and GCP to ensure high-quality laboratory services supporting clinical trials.

Services include laboratory setup, accreditation support, and compliance training.

9. Good Regulatory Practice (GRP)

Ensures compliance with local and international regulatory requirements.

Services include regulatory strategy development, dossier preparation, and submission management.

These GxP services are integral to maintaining the UK's reputation for high standards in life sciences and healthcare, ensuring that products and processes meet stringent safety, efficacy, and quality

[skillbesolution]

Pharmaceutical Computer System Validation and Regulatory Affairs Courses: Essential Knowledge for Industry Professionals

Introduction to Pharmaceutical Computer System Validation

Pharmaceutical Computer system Validation (CSV) is a critical process in the pharmaceutical industry. It ensures that computer systems used in drug development and manufacturing meet regulatory requirements and function as intended. CSV is essential for maintaining the integrity, security, and reliability of data.

The Importance of Computer System Validation in Pharmaceuticals

CSV is not just a regulatory requirement but a fundamental part of ensuring product quality and patient safety. Validated systems help prevent errors, data breaches, and ensure compliance with Good Manufacturing Practices (GMP). By validating computer systems, pharmaceutical companies can avoid costly recalls and regulatory penalties.

Key Steps in Computer System Validation

1. Planning and Preparation: Developing a validation plan is the first step. This includes defining the scope, objectives, and responsibilities.

2. Risk Assessment: Identifying and evaluating potential risks associated with the computer system.

3. Requirement Specifications: Documenting the functional and operational requirements of the system.

4. Testing: Conducting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) tests.

5. Validation Report: Compiling the findings and ensuring that all aspects of the validation process are documented.

Understanding Regulatory Affairs

Regulatory affairs (RA) in the pharmaceutical industry involve ensuring that companies comply with all of the regulations and laws pertaining to their business. Regulatory affairs professionals are responsible for keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products.

Importance of Regulatory Affairs Courses

Regulatory affairs courses equip professionals with the knowledge and skills needed to navigate the complex regulatory landscape. These courses cover a wide range of topics including drug development, regulatory compliance, and submission processes.

Key Topics Covered in Regulatory Affairs Courses

1. Regulatory Framework: Understanding global regulatory environments, including FDA, EMA, and other regional authorities.

2. Drug Development Process: Learning about the stages of drug development and the regulatory requirements at each stage.

3. Compliance and Documentation: Mastering the art of maintaining compliance and proper documentation.

4. Submission Procedures: Gaining insights into the preparation and submission of regulatory documents.

5. Post-Marketing Surveillance: Understanding the requirements for monitoring the safety and efficacy of drugs after they have been marketed.

Benefits of Pursuing Regulatory Affairs Courses

1. Career Advancement: Regulatory affairs professionals are in high demand. Completing these courses can significantly boost career prospects.

2. Comprehensive Knowledge: These courses provide a thorough understanding of the regulatory processes.

3. Skill Enhancement: Enhance skills in areas such as regulatory writing, strategic planning, and project management.

Integrating CSV and Regulatory Affairs Knowledge

Professionals who are knowledgeable in both CSV and regulatory affairs are invaluable assets to pharmaceutical companies. Their expertise ensures that systems are not only compliant but also efficient and effective. Integrating knowledge from both fields can lead to improved quality control, streamlined processes, and better overall compliance.

Conclusion

In the rapidly evolving pharmaceutical industry, staying updated with the latest regulatory requirements and validation techniques is crucial. Pharmaceutical computer system validation and regulatory affairs courses provide the necessary knowledge and skills to ensure compliance and maintain high standards. Investing in these educational opportunities can lead to a successful and rewarding career in the pharmaceutical sector.