Equipment Qualification

Quality Assurance
1

How do service providers stay abreast of pharmacopeia changes - is it their responsibility or is it the responsibility of the customer. Should they be categorising their equipment based on USP categorisation so as to ensure correct qualification and validations are recommended to their customers.
A simple off the shelf pH meter is now being used in, continuous manufacture and so its application may change - what impact will this have on the IQ/OQ.
What does industry expect from service providers wrt equipment qualification etc.
Any thoughts would be most welcome.

2

Dear
Could you please elaborate and simplify.

Thanks

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3

I am looking to establish how industry view service providers in terms of levels of service and responsibility pertaining to guidelines and pharmacopoeias. Do we put too much trust in our service providers for keeping on top of updates in guidance’s, or is this part of the contract. Do our technical agreements reflect this responsibility or is it just taken for granted?

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4

Dear,

Generally the service provider should be first audited and approval shall be made upon evaluation by in-house SOP procedures.
Usually the outside service provider must have accreditation/certification and all.
They perform the qualification study as per guideline requirements, but we need to verify and additional aspects can be covered as per site qualification SOP.

Thanks

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