Qualification of Excipients for Use in Pharmaceuticals

http://ipecamericas.org/sites/default/files/ExcipientQualificationGuide.pdf

IPEC is an international industry association formed in 1991 by manufacturers and users of excipients. It is an association comprising three regional pharmaceutical excipient industry associations covering the United States, Europe, and Japan (which are known respectively as IPEC-Americas, IPEC Europe, and JPEC). IPEC’s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace and the development of best practice and guidance concerning excipients.

Raw Materials for the Production of Cell-based and Gene Therapy Products

http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/11/WC500153800.pdf

 

Certificate of Analysis Guide for Pharmaceutical Excipients

http://ipec-europe.org/UPLOADS/CoA-guide-2013.pdf

International Pharmaceutical Excipients Council (IPEC) is an international industry association formed in 1991 by manufacturers, distributors and end-users of excipients. At the time of writing there are regional pharmaceutical excipient industry associations including the Americas, Europe, China, and Japan. IPEC’s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of best practice and guidance concerning excipients

SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

http://apic.cefic.org/pub/guidelinesupplierqualification_200912_final.pdf

Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines.

Certificates of Analysis

http://www.bcit.ca/files/appliedresearch/pdf/certificates_of_analysis_nov_08_nw.pdf

A very common question asked by manufacturers, suppliers and contract laboratories is: “what should be on a certificate of analysis?” Let’s start from the beginning by defining a “certificate of analysis” or “CofA.” Alas, that modern mainstay of electronic information, Wikipedia, is silent on the topic. A Google search, however, turns up hundreds of examples of actual certificates but surprisingly few definitions

 

Raw Materials Testing Considerations and Benefits

http://cdn2.hubspot.net/hub/159220/file-18393937-pdf/docs/raw_materials_failure.pdf?t=1421649211293

http://c.ymcdn.com/sites/www.casss.org/resource/resmgr/imported/WCBPCMC09CordobaRodriguezSlides.pdf

Many raw materials suppliers do only a fraction of their business with pharmaceutical, personal care products or cosmetics companies. A raw material thus may have multiple uses. Consequently specifications may be set to ensure consistency of the material from lot to lot. However, the specification boundaries set by a particular supplier, although consistent, can be much wider than those acceptable for GMP manufacturing purposes.

 

The International Pharmaceutical Excipients Council

http://ipec-europe.org/UPLOADS/CoA-guide-2013.pdf

 

International Pharmaceutical Excipients Council (IPEC) is an international industry association formed in 1991 by manufacturers, distributors and end-users of excipients. At the time of writing there are regional pharmaceutical excipient industry associations including the Americas, Europe, China, and Japan. IPEC’s objective is to contribute to the development and harmonization of international excipient standards, the introduction of useful new excipients to the marketplace, and the development of best practice and guidance concerning excipients

Certificates of Analysis

http://www.bcit.ca/files/appliedresearch/pdf/certificates_of_analysis_nov_08_nw.pdf

 

A very common question asked by manufacturers, suppliers and contract laboratories is: “what should be on a certificate of analysis?” Let’s start from the beginning by defining a “certificate of analysis” or “CofA.”

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC)

http://apic.cefic.org/pub/guidelinesupplierqualification_200912_final.pdf

 

 

SUPPLIER QUALIFICATION & MANAGEMENT GUIDELINE

Manufacture of Medicinal Products and the Active Pharmaceutical Ingredients (APIs) used as starting materials in the production of these products is subject to strict good manufacturing practice regulations that are designed to ensure their quality, safety and efficacy. This ensures that patients worldwide and at any time can have confidence in the quality, safety and efficacy of medicines

Water purification in the pharmaceutical industry

https://library.e.abb.com/public/0b52bf2c0b4f18f9c1257983005619cb/AD_RandC_007-EN.pdf

 

The conditions for water purification in the pharmaceutical industry are subject to stringent standards. Satisfying these requirements is essential for companies wishing to prove that their products have been safely produced and are suitable for sale both at home and overseas