SCM

Quality Agreement Guidelines and Template
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Quality Agreement Guidelines and Template

ByPharma Digest

One of the biggest issues facing the pharmaceutical industry and patients today is quality, integrity and security of the pharmaceutical supply chain, preventing contamination (adulteration) and eliminating counterfeits. A suitable Supplier Qualification Program has hence to be implemented by each user of purchased APIs (or intermediates). A major element of such a supplier qualification program…

Vendor Qualification in Pharmaceutical Industry
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Vendor Qualification in Pharmaceutical Industry

ByPharma Digest

The primary step for Manufacturing is to ensure that API (Drug Substance) Vendor Qualification is complied to manufacture a FDF- Finished Dosage Form / Formulation (Drug Product) which confirms the Product Quality. The same fundamental is applicable to API for which Key Starting Material (KSM) is sourced for API manufacturing. Every company will have a…