Additional manufacturing lines - combination products

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

Hi All,

Just wondering if anybody has any expertise on guidance for additional lines?

I am updating a company procedure for process validation. The proposed wording is as follows. Am I covering everything that would be considered industry standard in medical device and pharma?

IQ / OQ / PQ definition:
"IQ – Evaluation of processing and test equipment is required to ensure that the equipment and its software have been manufactured/installed to the manufacturer’s specifications and are capable for the intended operation.
OQ – provides a high degree of assurance that the process, when run at predetermined limits, is capable of producing product that meets all specifications.
PQ – demonstrates that the process, when run under normal operating conditions is capable of consistently producing product that meets predetermined specifications.

Additional lines – current requirements:
If a validated manufacturing line is replicated, typically for the purposes of introducing additional manufacturing capacity, the following is required:

  • IQ of each piece of equipment on the additional manufacturing line
  • OQ of each replicated process on the additional manufacturing line, unless a documented rationale can be provided to justify not repeating OQ. Refer to Appendix 3 for details on what needs to be considered.
  • A determination of the level of PQ testing, relevant to the additional manufacturing line. The level of testing is typically a reduced level in outputs tested from what was carried out as part of the original PQ and may be justified based on factors such as:
    o knowledge of the process
    o quality history of the processes
    o operator training/qualification requirements
    o level of experience of operators on the replicated line
    o Proven and effective process controls

IQ requirements – as per IQP

OQ requirements – as per OQ decision tree

  • Will environment change?
  • Any changed process equipment?
  • Any change to process or process set-up?
  • Any change to in-put materials?
  • Any change to measurement methods or specifications?
  • Any change to operator training/qualifications?
    o If No – document rationale for No OQ/PQ

PQ requirements, as per above……………

Appreciate your input on this.

Rgds,
P.

2

Have a few pointers on what I would expect procedurally:

A) I would strongly advice to proceduralize at least one PQ-run at set-point as documented evidence that equipment/system is fit for purpose. My experience is that it is hard to justify less than this, even if the lines should be identical. Additionally, that would give good confidence and serve as documented evidence moving forward into PV.

B) Has the relation to Facility Qualifcation Status been covered anywhere in this procedure? Impact of additional manufacturing lines on environmental conditions need to be covered somewhere. A reference towards present procedure for Qualification/Classification of Facilities might be applicable?! Potential re-qualification of the facility should be mandatory part of these types of projects.

Best Regards
Jonas Waltersson
QA Specialist Validation