GMP Society

The GMP Society is an international organisation for Good Manufacturing Practices (GMPs) “Quality Professionals” to grow professionally and interact with like-minded individuals. We provide a forum for the free exchange of ideas and information to improve the production of pharmaceutical (medicinal) drug products.

Our member-led organisation affirms and promotes the principles of GMPs in all our professional activities by:

• Striving to protect the integrity of the pharmaceuticals we produce;
• Creating an environment where all products manufactured for human and veterinary use are of superior quality to confirm the well-being of the patient who uses our products;
• Providing training programs and certification programs to educate professionals with recognised, superior qualifications as we facilitate the development of GMP quality professionals in all markets, especially developing nations and regions;
• Fostering an environment of support to sustain not only our own companies, but all the companies manufacturing APIs and drug products for human and animal use;
• Working towards creating one international GMP standard for drug products and become recognised as a primary voice for GMP standard settings by regulatory authorities;
• Providing opportunities and benefits for our members in:
  • Information sharing and networking
  • Training
  • Education
  • Career development and
  • Personal advancement opportunities

Through our analysis and official documents, we will analyze international pharmaceutical regulations to provide compliance insight and focus for proper implementation, where appropriate. Communication among members is facilitated by active blogs, workshops, training programmes, conferences, GMP Review journal and our book publication program(s). 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

5 Ways for Pharmaceutical Cleanrooms to Achieve New GMP Standards

                                                    Image: SERVICOR™

As the pharmaceutical industry faces tightening regulations and potential supply chain disruptions, both domestically and internationally, manufacturers must prioritize maintaining Good Manufacturing Practices (GMP) to ensure continued success and differentiation in a highly competitive market. 

Achieving GMP-compliant cleanrooms is vital for ensuring the highest standards of product safety, quality, and efficacy. However, compliance is just the starting point—these cleanrooms must also be designed to optimize performance, minimize contamination risks, and enhance operational efficiency. With ongoing regulatory updates, particularly around Annex 1, pharmaceutical companies need to stay ahead of the curve by implementing strategies that prevent disruptions to production while meeting the ever-evolving compliance requirements. Here are five key cleanroom considerations to ensure regulatory changes do not disrupt operations.

1.    Cleanroom Materials and Construction
 

Achieving GMP compliance begins long before cleanroom construction starts. It begins with selecting a cleanroom manufacturer partner who provides certificates of compliance and ensures that materials used in construction are free from contaminants. Proper handling of materials is crucial to avoid cross-contamination during manufacturing. Non-porous surfaces and chemical-resistant materials should be chosen to ensure the durability and ease of sterilization needed in pharmaceutical production environments.

"The choice of materials and how components are sealed is essential," says Mark Zabala, expert in cleanroom design, regulatory compliance and senior sales manager of modular cleanroom, SERVICOR™, by Nortek Air Solutions CleanSpace. "Any gaps or seams left during construction can introduce potential contamination and structural risks." Cleanrooms designed with steel modular components, like SERVICOR, ensure that the structure is sound and allows for a custom fit to meet the unique needs of each facility. These features are particularly critical for pharmaceutical manufacturing where contamination control is paramount.

2.    Flush Walls and Flush Ceilings: A Foundation for GMP Pharmaceutical Cleanrooms

A key feature in GMP-compliant pharmaceutical cleanrooms is the removal of surfaces that could harbor contaminants or complicate cleaning processes. Flush walls and ceilings are essential to maintaining a contamination-free environment, as they are much easier to clean and maintain.

"Flush surfaces minimize the potential for microbial growth or particle generation, which is vital for processes like aseptic filling or sterile drug production," Zabala explains. "Eliminating joints, seams, and fixtures that are difficult to clean significantly reduces the areas where contaminants can accumulate."

This design not only makes cleaning more efficient but also ensures the integrity of the cleanroom environment is upheld, especially for critical pharmaceutical applications where sterility and minimal contamination are non-negotiable.

3.    Airflow and HVAC Systems: Controlling Contamination at the Source

Airflow and HVAC systems are fundamental to maintaining GMP cleanroom standards. These systems regulate air change rates and filter airborne particles, ensuring minimal contamination. Pharmaceutical cleanrooms typically use high-efficiency particulate air (HEPA) or ultra-low penetration air (ULPA) filters to capture airborne particles and microorganisms that could compromise product quality. "The HVAC system must maintain specific airflow rates and pressures while ensuring uniform air distribution," says Zabala. "This is crucial to preventing cross-contamination and ensuring that the air in critical areas remains uncontaminated."

Well-designed airflow systems prevent contaminants from circulating within the cleanroom by pushing them toward escape or return vents. Proper placement of equipment, workstations, and technology is key to not obstructing this critical airflow, which is designed to maintain the cleanroom’s stringent requirements. Additionally, pressure differentials—positive pressure in sterile zones and negative pressure in hazardous areas—are essential to controlling the flow of air and ensuring containment where needed.

4.    Advanced Monitoring and Data Logging Challenge

As technological advancements continue to evolve, monitoring systems in pharmaceutical cleanrooms must become more sophisticated to ensure consistent compliance with GMP guidelines. These systems track critical environmental parameters, including temperature, humidity, particle counts, pressure differentials, and access control. "Real-time monitoring is vital for maintaining GMP standards," says Zabala. "Automated monitoring systems provide continuous data logging, allowing operators to track trends and take proactive steps if any environmental parameters go out of specification."

These systems trigger alarms if particle counts or other conditions exceed predefined thresholds, enabling rapid corrective actions. Beyond regulatory compliance, data logging is critical for traceability during inspections and ensures transparency and accountability.

A recent study found that information management already takes up nearly 30% of staff time. Digital twin technology, applied to Automated Material Handling Systems (AMHS), allows for a virtual replica of the cleanroom logistics to be created. With an expected increase in the number of organizations using these twins for data logging, pharmaceutical manufacturers can streamline and continue to innovate to increase speed to market.

5.    Validation and Continuous Improvement

Validation is the final step in ensuring that a pharmaceutical cleanroom is fully GMP-compliant. This process involves rigorous testing and measurements to confirm that the cleanroom’s environmental conditions are within acceptable parameters and that all systems are functioning correctly.

"Validation ensures the cleanroom supports the production of high-quality, safe pharmaceutical products," Zabala explains. "It’s not just a checkbox to get up and running, it’s about verifying that the environment is continuously controlled and monitored."

Once operational, ongoing monitoring, regular maintenance, and requalification are essential to maintaining compliance. This continuous improvement process ensures that the cleanroom adapts to evolving industry standards and remains efficient, reducing the risk of non-compliance or production delays.

A Holistic Approach to GMP Pharmaceutical Cleanroom Compliance
 

To meet GMP standards, pharmaceutical cleanrooms require a holistic approach that includes cutting-edge design features, continuous monitoring, rigorous material selection, and thorough validation processes. Critical elements such as flush walls and ceilings, advanced airflow systems, and real-time data logging all contribute to a sterile environment capable of meeting the exacting requirements of pharmaceutical production.

Additionally, comprehensive Standard Operating Procedures (SOPs) are essential. The perfect cleanroom design will only be effective if backed by SOPs that govern gowning, cleaning, maintenance, and behavior within the cleanroom. Working with professionals to create robust SOPs will ensure the cleanroom operates as intended, further supporting GMP compliance.

As regulatory requirements continue to evolve globally, pharmaceutical cleanroom design must be treated as an ongoing process that demands attention to detail, regular reassessment, and operational excellence. By integrating the latest technologies, materials, and monitoring systems, pharmaceutical manufacturers can ensure their cleanrooms not only meet current GMP standards but also provide a foundation for future innovation and growth.

--

About Mark Zabala

 
With 18 years of experience in the cleanroom industry, Mark Zabala’s comprehensive skill-set spans field installations, site coordination, cleanroom design, and engineering. Mark has been involved with IEST as a voting/contributing member in several working groups, as well as an active member of ISPE and SEMI.  His extensive background enables him to gather critical insights in his role as senior sales manager at Nortek Air Solutions CleanSpace that lead to the successful implementation of cleanroom systems for customers and partners alike.

About Nortek Air Solutions CleanSpace 

 
With world-class brands like CleanPak®, Huntair®, SERVICOR®, Temtrol®, Governair® and Mammoth® Nortek CleanSpace produces innovative, safe cleanroom solutions that meet and exceed strict contaminant and particulate-free environment standards so that customers can continue creating products that make the world safer, healthier, and more productive. Nortek Air Solutions CleanSpace has engineered over 20 million square feet of cleanroom systems that exceed strict contaminant and particulate-free regulations to keep the world’s most innovative spaces running. Learn more about NortekAir.com.
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

GMP Validation - a book to guide you through the international requirements

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to provide a map and a compass for navigating the choppy waters of international regulations.

Available via Euromed

GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.

This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification. The book concludes with four useful appendices providing templates to aid the reader.

Part A: Essential tools for the validation manager

 
1. Qualification, Validation and the Formalised Approach
2. Validation Documentation
3. Hazard Identification and Assessment of Risk
4. Validation Project Management and Risk-based Problem Solving
5. The V-model and the Lifecycle Approach to Validation
6. Quality Risk Management and the Validation Process
7. Data and Statistics for the Validation Manager
8. Validation Errors: Concept and Case Study
9. Calibration Process and Setting Calibration Criticality
10. Setting the Standards for New Equipment Purchases
11. Process Validation: Maintaining Quality and Compliance

Part B: Case studies and GMP concepts for validation

 
12. Audit and validation requirements of single-use technologies
13. Containment system integrity: microbial challenges for sterile products
14. Cleanroom design, commissioning and verification
15. Qualification of disinfectants
16. Utility Design and Qualification for Efficient Pharmaceutical Operations
17. Pharmaceutical Water Systems
18. Equipment Design: Assessing Cleaning and Hygiene
19. Autoclaves and Steam Sterilisation
20. Pure Steam for Sterilisation
21. Cleaning Validation: Balancing GMPs and Risk
22. Compressed Air and Other Gases
23. Data Loggers and Temperature Mapping
24. Microbiological Method Validation
25. Data Integrity and Qualification
26. Isolator Sterility Validation
27. Analytical Method Development
28. Analytical Method Transfer
29. Computerised System Software Validation
30. Sterile Filter Validation

Part C: Appendices

 
Appendix 1: Validation Master Plan.
Appendix 2: IQ Protocol.
Appendix 3: OQ protocol.
Appendix 4: New equipment risk assessment.

Available via Euromed 

 

About the Author

 
Tim Sandle originally trained as a parasitologist before moving into microbiology. He took first degrees in microbiology and politics, and then proceeded to study for a master’s degree and a PhD part-time. Tim is currently Head of GxP Compliance and Sterility Assurance at Bio Products Laboratory. He is additionally a visiting tutor at the University of Manchester and University College London lecturing in pharmaceutical microbiology. He is a longstanding committee member of Pharmig and has served on several other international committees and editorial boards. Tim has written a number of books, and numerous papers, and technical articles relating to GxP concerns, microbiology and contamination control.

Available via Euromed 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Avoiding Errors With The Batch Release Process: Best Practice CGMPs

Despite most companies having effective batch release procedures, errors can occur leading into products being released which are unsuitable (for the different reasons where a recall can occur). Such issues may be picked up by the company, consumers, or medical staff (such as in the form of a customer complaint). For example, one common reason for recalls is where process for testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications or identity and strength of each active ingredient prior to release (as per 21 CFR 211.165(a)).

 

 

 

To avoid such issues, this article considers some best practices for the batch release process.

 

 

Sandle, T. (2022) Avoiding Errors With The Batch Release Process: Best Practice CGMPs, Journal of GxP Compliance, 26 (2). DOI:  https://www.ivtnetwork.com/article/avoiding-errors-batch-release-process-best-practice-cgmps

 

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Revision of PIC/S GMP Guide (PE 009-16)

 

The PIC/S GMP Guide to Good Manufacturing Practice (GMP) for Medicinal Products has been revised to include:

 

·         A revised Annex 13 on the Manufacture of Investigational Medicinal Products; and

·         A new Annex 16 on the Certification by the Authorised Person and Batch Release.

 

PIC/S Annex 13 has been revised based on EC Regulation No. 536/2014 on Clinical Trials, which will replace EU Annex 13. This is in line with the Co-operation Agreement between PIC/S and EMA, which provides that the PIC/S and EU GMP Guides should be harmonised with the aim of keeping GMP standards equivalent, thus facilitating the exchange and use of information concerning the manufacture of medicinal products.

 

 

PIC/S Annex 16 is a new annex to the PIC/S GMP Guide. Historically, PIC/S did not adapt EU Annex 16, when it was adopted as part of the EU GMP Guide. Initially, PIC/S considered this annex to be EU-specific and difficult to transpose for PIC/S purposes, in particular since the PIC/S GMP Guide is limited to the manufacture of medicinal products and not to import and distribution.

 

See: https://picscheme.org/en/news/revision-of-pics-gmp-guide-pe-009-16

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)