Some recent questions I received pertaining to CMO and equipment / process verification and validation (V&V), with my answers:
Ques 1. In a CMO context, where very different process are run, should the PQ of the equipment be specifically performed for each manufacturing process?
Ans: You could validate the equipment for it's general use(s), and/or expected uses. Then have your V&V SOP(s) address a method to validate or verify the particular run for a client that adds the unique requirements of that client's lot(s). Or add such additional V&V requirements by means of a 1st Article inspection (and/or other tests / QC) addressing the additional requirements.
Ques 2. Is it possible to perform qualification of the equipment during the performance qualification of the process? In this case, could the critical parameters, defined for the process, be used for the PQ of the equipment? Or do they need to be specific for each piece of equipment?
Ans: The approach I favor (and explained in my webinars, but by no means the only way) is to qualify / validated the equipment by means of the IQ, OQ, and PQs. The critical parameters are addressed under the OQ, and can include DOE. The PQs address the robustness, repeatability and reproduceability of the the equipment given all allowable worst case inputs (shifts, RM lots, etc). Each piece of equipment needs to be so addressed. I generally do a process V&V for such things as cleaning, etc. However, I have done process V&V for the entire production process, in which case, I have separate verifications under the overall process validation, that address each piece of equipment, as explained in the webinar briefly. Note the need to define terms per your company's "working" definitions, also emphasized throughout my applicable webinars.
Ques 3. Which is the criterion to define a piece of equipment as critical in a manufacturing process?
Ans: The key criterion to such definition is the equipment's contribution to the "critical quality attributes" of the element of the final product it acts upon, especially as it relates to the end user, the patient / clinician. This is an important point that I try to emphasize in my many webinars o V&V, and recommended tying such decisions in the V&V test cases / scripts to a Product Risk Management File / Report per ISO 14971 or ICH Q9. It's possible to develop a generalized Risk document for a CMO, and then add some unique requirements to it in the batch record, tied to an additional analysis of the client's product.
Obviously 1 and 3 require obtaining some requirements as to quality attributes and safety / efficacy of the product's field use from the client, perhaps as part of the contract, a quality agreement, questionaire, or similar document. Rather than being a burden, I think such a requirement might add to a company’s credibility in the eyes of its customers.
-- John E. Lincoln, jelincoln.com
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