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Cleanroom Guidelines and Standards:
Key differences & commonalities

By Stefaan Vanhalle - R&D Manager

 

As we reach the final part of our series on Cleanroom guidelines and standards, we turn our focus to the key differences and commonalities across the leading regulatory frameworks that govern pharmaceutical manufacturing. In this installment, we will see how GMP Annex 1, PIC/S, ISO 14644, US FDA cGMP, ICH, and USP align and diverge in their approaches to cleanroom classification, monitoring, and design. By understanding these distinctions and overlaps, professionals in the pharmaceutical and life sciences industry can better navigate the complex landscape of global compliance, ensuring the highest standards of quality and safety in pharmaceutical production.

Key differences and commonalities

The GMP Annex 1, PIC/S (Pharmaceutical Inspection Co-operation Scheme), ISO 14644, US FDA cGMP ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), and USP (United States Pharmacopeia) are all regulatory or industry standards that address various aspects of pharmaceutical manufacturing and quality control. 


Cleanroom Classification

  • GMP Annex 1 and PIC/S:
    Both GMP Annex 1 and PIC/S provide guidelines for the classification of cleanrooms, particularly in the context of sterile medicinal product manufacturing.
    They emphasize the importance of maintaining specific air cleanliness levels to minimize the risk of contamination during aseptic processing.

  • ISO 14644:
    ISO 14644 is an international standard specifically dedicated to cleanroom classification and contamination control.
    It defines cleanliness classes based on particle counts in the cleanroom environment, offering a standardized approach applicable globally.

  • US FDA cGMP ICH and USP:
    While the US FDA cGMP regulations and ICH guidelines touch upon cleanroom requirements, they do not provide detailed classification criteria.
    USP, in contrast, emphasizes general cleanroom principles but leans on ISO standards for specific classification requirements.



Monitoring and Design

  • GMP Annex 1 and PIC/S:
    Both standards stress the need for robust environmental monitoring programs in cleanrooms.
    They outline requirements for continuous monitoring of critical parameters such as air quality, temperature, and humidity.

  • ISO 14644:
    ISO 14644 provides detailed guidance on monitoring contamination in cleanrooms, specifying acceptable limits for airborne particulate contamination.
    It also addresses the need for regular monitoring and periodic testing to ensure compliance.

  • US FDA cGMP ICH and USP:
    FDA cGMP regulations and ICH guidelines emphasize the importance of monitoring and control but may not provide specific details.
    USP provides general principles for cleanroom design and monitoring, often referring to other standards for specific requirements.


Areas of Commonality and Convergence

Quality standards:
All standards share a common goal: ensuring high-quality standards in pharmaceutical manufacturing.
They emphasize the importance of quality control measures to guarantee the safety and efficacy of medicinal products.

Compliance:
Each standard establishes guidelines or regulations that pharmaceutical companies must adhere to, promoting compliance with industry best practices.

Documentation:
Robust documentation of processes and procedures is highlighted across all standards, supporting traceability and accountability.
International Harmonization:
GMP Annex 1, PIC/S, and ICH contribute to international harmonization of pharmaceutical regulations, facilitating consistency in manufacturing practices globally.


Overlap and Integration:
There is often overlap among the standards, with companies needing to integrate requirements from multiple sources to meet global regulatory expectations.
In conclusion, while there are differences in approach and specificity among these standards, they collectively contribute to the establishment of a comprehensive framework for maintaining high standards in pharmaceutical manufacturing and cleanroom operations. Companies must navigate and integrate these standards to ensure compliance and the delivery of safe and effective pharmaceutical products.
 

If you have missed the previous parts or you’re interested in reading all the articles again please check our blog or contact us via communication@staxs.eu.

References

•    The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Brussels, 22/8/2022 C(2022) 5938 final
•    PIC/S guide to good manufacturing practice for medicinal products (PE 009-17 25/8/2023)
•    PIC/S guide to good practices for the preparation of medicinal products in healthcare establishments (PE 010-4, 1/3/2014).
•    ISO14644 Series (1-18)
•    https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations
•    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice
•    https://www.ich.org/page/search-index-ich-guidelines
•    https://www.uspnf.com/