15/16 February 2022
The origins of the WHO GMP Guide go back to 1967. The Guide, which has undergone many revisions and changes since then, was last published as Annex 3 of the Technical Report Document TRS 961 in 2011. The document is so to speak the mother of all GMP documents of the WHO.
Following sections have been changed in this draft:
1. Pharmaceutical quality system (formerly "quality assurance")
2. Good Manufacturing Practices for pharmaceutical products
7. Contract production and analysis
17. Good practices in quality control
Similar to ICH Q10 the QA system (Quality Assurance) in Chapter 1 was replaced by the Pharmaceutical Quality System (PQS), and thus the life cycle idea was reinforced. The active role of senior management is required now within the quality system here as well. Moreover, senior management is also responsible for the implementation and review of the PQS. In the sub chapter on deviations, the term CAPA was added. Deviation investigations were thus extended by preventive measures and the monitoring of these measures.
The ICH approach is also reflected in Chapter 2. Here GMP was previously described as a means to reduce risks in pharmaceutical production. In the new text, GMP is not only supposed to minimise the risks but manage them. Also, the term GDP (Good Distribution Practice) is mentioned here for the first time.
Chapter 7 now also includes sub-contractors. This means that contract givers should also be able to audit the premises of sub contractors by contract. The contract giver’s responsibility to ensure that all products and materials of the contract manufacturer met the specifications were extended by a monitoring and the review of the performance of the contract manufacturer – including the implementation of the necessary improvement measures.
You can find the new draft of the WHO guideline, i.e. the amended chapters and the comparison with the previous text as well as the forms for comments in the ECA Members’ Area. To download, you have to be a registered ECA member (see the ECA membership opportunities in case you are not yet member). Deadline for comments is 15 September 2013.