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Pharmaceuticals/Reg CIP validation

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Question
Dear Mr Micheal,

I have a high shear mixer fitted with a CIP system and I am aware that it should be qualified before cleaning validation. So when is the appropriate to validate- OQ or PQ ? And what test items should be included in the testing.
Thank you once again.
regards,

Answer
Interesting question.

You have several qualifications to perform:

a. if the system is computer controlled - OQ of the computer system (hardware and software)
b. OQ/PQ of the mixing process
c. OQ/PQ of the CIP cleaning system

Perform the qualifications in the sequence shown above. Good Luck.

Pharmaceuticals

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Michael Anisfeld

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Disclaimer: SORRY BUT I DO NOT ANSWER QUESTIONS RELATED TO: DRUG ACTIONS/INTERACTIONS, INTERNET DRUG PURCHASES, RESULTS OF DRUG TESTS, IDENTIFYING DRUGS (FOR WHICH YOUR LOCAL PHARMACIST IS THE BEST PERSON TO CONSULT). My expertise is answering questions relating to pharmaceutical manufacturing and quality technologies, drug regulations and specifically GMP requirements

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