RE: Bulk product manufacturing contract Contribution from JD Mallet written on 9/3/2010 at 16:32
Original contribution: Bulk product manufacturing contract written by Igor on 9/3/2010 at 14:49) Dear Igor,
The GMP Manual you quote is fully right. That's true that the paragraph 7.3 of the EU-GMP guide only states that "The contract giver is responsible for assessing the competence ..." but you have to know that the same requirement in the WHO-GMP guide which is very similar to the EU guide states that the contract giver has TO Audit the subcontractor for assessing its competence.
This is, in fact, quite logical because even if the sub-contractor is regularly inspected but the competent authority, it is not assessed for all the products he may manufacture.
The only "competent" entity concerning a particular product is obviously the Contract (or Order) Giver. It's him and only him who is supposed to have the perfect pharmaceutical, technical and scientific knowledge of the particular product.
This is also why most of GMP auditor are not in the perefect line when they audit their subcontractants for general GMP compliance while they should focuse on the GMP compliance related to the particular operations of the particular product(s).
General GMP Compliance is normally assessed but the competent inspectorate.
To make it short there is no real difference with the vendor qualification of an API. For non-active ingredient the "documentation assussment" could be acceptable provided there is no significant risk associated with the ingredient. But, if it goes around PEG I would say that, heree too, an audit is mandatory.
Last, I am a little bit surprised with your assertion that "different inspectors have a different attitude on this topic". Would you be so kind to tell me which country's inspectors are not requiring the audit of the subcontract ?
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