FDA Publishes Q&A Document on ICH Q7

May 24, 2018 Suzanne Konigsberg

By:       Mustafa A. Zaman, Principal Consultant and Siegfried Schmitt, Principal Consultant, PAREXEL Consulting

In April 2018, FDA published a guidance document that answers questions about the implementation of ICH Q7 – ‘’Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions & Answers-” – and is a useful addition to the ‘toolbox’ the FDA use to evaluate Active Pharmaceutical Ingredient (API) manufacturers.

The specific guidance was published in the year 2000 and over the years several agencies have published clarifying Q&A documents, including ICH in 2015. This is the first such document from the US FDA. Changes in technology, science and the regulations gave rise to requests for clarification or even interpretation of certain sections in ICH Q7. These are now provided in this Q&A document. 

This informative Question and Answer (Q&A) guideline:

  • Helps pharmaceutical companies ensure that APIs meet quality and purity characteristics.
  • Clarifies some of the ambiguity in certain sections in ICH Q7.
  • Topics addressed in the Q&A document include:
    • Quality Management;
    • Personnel;
    • Buildings & Facilities - Containment;
    • Process Equipment - Cleaning;
    • Documentation & Records;
    • Materials Management;
    • Production & In-Process Control;
    • Storage & Distribution;
    • Laboratory Controls, Validation, Change Control
    • Rejection and Reuse of Materials.
  • The document also elucidates the requirements for:
    • Releasing raw materials;
    • APIs Manufactured by Cell Culture/Fermentation
    • Sampling;
    • Acceptance Criteria;
    • Product quality review;
    • Risk Management (in the context of Quality Risk Management (ICH Q9);
    • Evaluation of material suppliers ( i.e. Agents, Brokers, Traders, Distributors, Re-packers, and Re-labelers);
    • APIs for Use in Clinical Trials.

PAREXEL is currently supporting clients in developing regulatory strategies as well as pre- and post-market submissions for a variety of small molecule and large molecule products to ensure that the Q7 guidance’s are correctly interpreted, so that they can be used as on-site assessment tools in order that their respective APIs meet the required quality and purity characteristics. This includes assessing a manufacturers current manufacturing capabilities, Quality Risk Management Tools and Quality Systems. PAREXEL experts cover all regulations globally.


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