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Overview…

Compendial pharmacopoeia 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.
What is the purpose of a compendia?
A compendium may concisely summarize a larger work. In most cases, the body of knowledge will concern a specific field of human interest or endeavour (for example: hydrogeology, logology, ichthyology, phytosociology or myrmecology), while a general encyclopedia can be referred to as a compendium of all human knowledge.

COMPENDIAL TESTING

As a drug sponsor or applicant, you are required to evaluate your drug substances and products according to standards in official compendia. A central challenge in compendial testing is the complexity and diversity of pharmaceutical compounds and the raw materials used in the process, which may require multiple methods or techniques to release them for clinical or commercial use. Compendial testing also requires significant resources and expertise, particularly in the areas of analytical chemistry and statistics, to ensure accurate and reliable results.
What is the compendia method?
What are Compendial Methods？ Compendial methods are standardized methods (protocols) from US Pharmacopoeia (USP). Compendial tests are performed to determine if the pre-set sepcifications are met and/or to address anticipated regulatory concerns.
 
What is USP compendia?
The USP Compounding Compendium provides access to the United States Pharmacopeia standards and the National Formulary (USP–NF), the official compendia of standards for drugs marketed in the United States.

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 Pharmacopoeia/National Formulary (USP/NF), the British Pharmacopoeia (BP), the European Pharmacopoeia (EP), or the Japanese Pharmacopoeia (JP).

Compendial pharmacopoeia 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.

Speak to an expert today and get further support on compendial testing and complying to regulatory requirements.