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13 September 2013

Pharmaceutical excipients

Excipients, which are contained inside drugs to a considerable amount, play a fundamental role as regards safety, quality and effectiveness of the drug itself.

As well as affecting the appearance of the drug, excipients often alter the physical features, significantly contributing to the stability or the release of the active ingredient in the pharmaceutical formulation.

Despite that, while in Europe the production of Medicinal Products and active ingredients is regulated by laws and guidelines, there is no definition of clear rules as far as regards the production of pharmaceutical excipients to date.

Whilst awaiting for the current law system to be cleared, we want to be of service to companies manufacturing pharmaceutical excipients to the purpose of implementing an effective Quality System, in compliance with what is found in the IPEC guidelines (International Pharmaceutical Excipients Council), which define the GMP regulations (Good Manufacturing Practice) as far as regards excipients.

 

Our consulting services

  • Definition, implementation and maintenance of a Quality System based on GMP regulations concerning pharmaceutical excipients, both integrating Quality Systems of ISO (International Organization for Standardization) kind, if available, and ex-novo if lacking.
  • Personnel training about Quality system and GMP regulations concerning GMP regulations for  pharmaceutical excipients
  • Preparation of high quality EIPs (Excipient Information Package)
  • Preparation of a template about the analysis certificate according to GMP
  • Planning of stability studies suitable for specific excipients and drafting of the relating reports

Our consulting are ideal to spare the excipient manufacturer the filling of countless quality questionnaires which the drug manufacturer usually requires, thanks to our drafting of highly detail level EIPs

Use cases

  • When an excipient producing company has to implement or improve its Quality System to be able to state sincerely that the produced excipient is of pharmaceutical grade
  • GMP regulations for excipients are already part of the American Pharmacopeia (USP, United States Pharmacopeia <1078>). A manufacturer who declares his excipient to be consistent with USP must guarantee not only compliance with the specific monograph, but also to <1078> chapter, that means he has to be able to work in compliance with GMP. Moreover, GMP for excipients will probably become compulsory in Europe as well. In any case, GMP rules for specific medicines manufacturers compel the latter to buy elements of the produced drugs according to GMP. For such reasons the operation of GMP for excipient manufacturers might become soon a Hobson’s choice.

 

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