New WHO Draft on GxP for Development
Last year the WHO published draft documents on "Good manufacturing practices for investigational products" (GMP for IMPs) and "Good practices for research and development facilities". After consolidation of comments received and review of feedback, revised versions of the two guidelines have now been published for a second round of public consultation. The deadline for comments is 31 August 2021.
WHO´s Good practices for research and development facilities
Compared to the previous version the revised version contains several changes and amendments, like, for example, the following:
- New Title: WHO good practices for research and development facilities of pharmaceutical products.
- Scope: The main focus is to provide GxP for the production of pre-clinical and not for human use batches, manufactured in pharmaceutical formulation and development facilities.
- The principles described may be applied to other products, such as biopharmaceutical products, vaccines and medical devices.
- GxP is to be considered as a general guide and may be adapted to meet individual needs. However, the equivalence of alternative approaches should be demonstrated.
- The Glossary has been amended and moved from the end of the document to section 3.
- Quality management: Development procedures should be documented. Cleaning procedures are developed, verified and validated.
- Where Qualification & Validation are performed, the scope and extent should be appropriate using a risk-based approach.
- Self-inspections should also cover data and data integrity.
- Personnel: The appropriate protective garments should be worn, based on operation performed and risk. Personnel who are ill should not engage in the manufacture of pharmaceutical products.
- Training should be provided in accordance with a written programme that covers topics such as the theory and practice of GMP and the duties assigned to them. The appropriate task-related training should be further provided based on technical requirements and activities undertaken.
- Packaging and printed materials should be stored in secure conditions so as to exclude the possibility of unauthorized access.
- GxP data (including records for storage) may be recorded by electronic data-processing systems or by photographic or other reliable means.
- During processing, detailed information should be recorded at the time each action is taken. Upon completion, the record should be dated and signed in accordance with Data Integrity expectations.
- "Processing and process validation" changed into "Processing and process design" with reference to ICH Q 8 / Q11.
- Analytical procedure development: Analytical procedures developed by research and development facilities should be documented in sufficient detail to facilitate their successful transfer, when required, and should be appropriately validated as fit for purpose.
- Cleaning procedure development, cleaning verification and cleaning validation: Cleaning verification is defined as the act of demonstrating that cleaning was done to an acceptable level; for example, between two batches.
More information can be found in the two draft documents entitled "WHO good manufacturing practices for investigational products" and "WHO good practices for research and development facilities of pharmaceutical products" on the WHO Medicines website under "Working documents in public consultation".