Chromatography Forum

OK, another cGMP question. I work at R&D/pilot manufacturing facility, and we make OTC pharmaceutical consumer products. Am I correct that all raw materials and intermediates received here (each lot) for use in consumer products for consumer tests and OTC stability assays MUST be assayed to meet the same Acceptance Tests that are required at our full scale production facilities?

For example: if the API must meet our company's purity test, identity test, color test, and solubility test at manufacturing QC, must those same tests be re-run at R&D if that same lot is received there for use? I'd think YES, or how else would one really know what it is, and if it's OK (like if it was mis-labeled)? Comments please.

CPG,

The short answer is 'Yes', just as you figured.

However, it is possible to avoid doing compete/full specification testing of the raw materials. At the minium, you would perform the appearance and identiification tests and you would accept the certificate of analysis that comes with the lot of raw material. You would need to have an approved (i.e. audited and certified by QA/regulatory compliance) vendor/supplier and there would need to be a tamper proof container used in the shipment.

This is all dependent upon the rules established by your QA and regulatory.


By the way, my last position was similar to yours. I worked for an OTC company in the R&D group and we had a pilot manufacturing facility (and all was cGMP compliant). I was indirectly involved with the raw materials group in that: (1) I was the author for the SOP on the preparation of specifications and (2) as the SME for the LIMS, I often assisted in the setting up of specifications within the LIMS.

Regards,
Dan