Merck

Compendial Testing & Regulatory Guidance

Numerous global standards, such as ISO, ACS, USP, PhEur, JP and FDA CFR can provide local and international pharmaceutical Analysis and quality control (QC) regulatory guidance.

Drug sponsors and applicants are required to propose specifications (i.e., attributes, analytical procedures, and acceptance criteria) for the excipients, drug substances, and drug products in their applications. These specifications should adhere to the quality standards in the United States Pharmacopeia/National Formulary (USP/NF), the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), or the Japanese Pharmacopoeia (JP). Compendial pharmacopeial tests are standardized protocols for many pharmaceutical raw materials and finished products. Testing and compliance to these standards detailed within compendial methods is a basic requirement for global manufacturing, release and distribution of pharmaceutical ingredients and drug products.


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