What are the FDA Requirements for Equipment Qualifications?

What requirements does the FDA have for equipment qualifications? This is a question that requires a more detailed look into the regulations. However, a current Warning Letter offers a more simple way for information.

If you take a look at the US GMP regulations for medicinal products (21 CFR 210/211) regarding equipment qualification, you will not find a clear requirement. In Part D on equipment, you can find guidance under §211.63. that equipment should be of appropriate design, size, and location for use as intended. General information on equipment surfaces regarding interactions can be found in §211.65. The requirement for maintenance is described in §211.67. Comparable passages related to premises are found in Part C of 21 Code of Federal Regulations (CFR) 211. In §211.68, emphasis is still placed on calibration, as well as inspection or testing in accordance with a written programme.

But the term equipment or room qualification does not fall.

In the currently valid FDA Guidance on Process Validation we can read the term qualification, but the classical qualification levels DQ, IQ, OQ, PQ mentioned in Annex 15 are not mentioned. This was different in the previous guideline, at least with regard to IQ and PQ.

But what is the importance of equipment qualification for the FDA?

A manufacturer of over-the-counter (OTC) medicinal products had neither sufficiently validated its manufacturing process nor sufficiently qualified its equipment. That lead to a Warning Letter. Explicitly, the FDA cited § 21 CFR 211.63, as described above. Further, the Warning Letter, citing the FDA Process Validation Guidance, specifically states that equipment qualification is an integral part of the process validation programme.  

The FDA requests in response by the OTC manufacturer to its Warning Letter:

• A validation programme with the corresponding subordinate documents (in particular to a Process Performance Qualification (PPQ) as well as the evaluation of intra- and inter-batch variabilities in a Continued Process Verification programme) 
• Timelines for the PPQ runs 
• PPQ plans

and

• an equipment and premises qualification programme, including SOPs

Conclusion: Although the topic of equipment qualification is not as prominent in the FDA Guidance on Process Validation as PPQ runs and Continued Process Verification, it is an integral part of the process validation programme and thus indispensable.

 You can find the Warning Letter to Seoul Cosmetics on the FDA website.

We will discuss what an EU and FDA compliant and still "lean" qualification can look like at the ECA Qualification and Validation Forum Update 2023 live online on 14/15 November 2023.