How does an Authority react if no Process Validation is available?

Recommendation

15/16 February 2024

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A successfully completed process validation is one of the basic GMP requirements for a product to be marketed. So, how does an authority react if a product is already on the market but no process validation has been carried out? The FDA provides answers in a current Warning Letter.

The Indonesian manufacturer assured that process validation would be carried out as a measure to address the lack of process validation. This was far from being enough for the FDA who required the naming of timelines for the completion of activities and more details. Furthermore, the FDA expects an assessment of the products that are on the market without process validation and still within expiry.

The FDA still wanted the following details:

• A detailed summary of the validation programme with regard to the product lifecycle with the corresponding written specifications.
• A detailed description of the Process Performance Qualification (PPQ) and the Continued Process Verification activities. For the Continued Process Verification, the description should also cover both intra-batch and inter-batch variation.
• Timelines for the PPQ of the respective products
• Process performance protocols

In addition, programmes and current SOPs for a previously missing cleaning validation were requested, as well as a programme, protocols and procedures on the missing equipment qualification. The FDA also requested a CAPA plan for cleaning procedures and practices. 

For further information please also see the FDAWarning Letter to PT. MegaSurya Mas.