MHRA requires active Maintainance of API Manufacturing Sites

The Medicines and Healthcare Products Regulatory Agency (MHRA) published a statement about maintenance of Active Pharmaceutical Ingredients (API) manufacturing sites and other sites named on marketing authorisations. The following text is taken from the MHRA press release:

"Through its inspection programme, the MHRA has encountered numerous examples of API manufacturing sites that are named on marketing authorisations but are not currently used and not fully maintained as approved suppliers. In some cases such API sites may never have supplied API for marketed product. This can also apply to other sites eg drug product manufacturing, importation or batch release sites. Therefore in order to clarify MHRA expectations the following guidance is provided:

  • The MHRA regards all API manufacturers that are registered on UK marketing authorisations to be approved to supply without further notice and with immediate effect; sites without proven documented GMP compliance status cannot be regarded as an effective back up supply source of starting material.
  • As a minimum, and in order to comply with EU directives on the use of GMP compliant APIs, the supplier approval process must be supported by evidence of effective GMP compliance of the API manufacturing site(s). As per European Medicine Agency (EMA) guidance it is expected that this will be confirmed via audit of the API manufacturing site by or on behalf of the relevant manufacturing authorisation holder. Audits should have been conducted at intervals not exceeding three years, by persons with appropriate training and experience, to confirm the current GMP status of the site.
  • Any API manufacturer listed on a UK marketing authorisation that has not been maintained as an approved supplier does not meet the EU requirements for starting materials to have been manufactured in compliance with EU GMP requirements.
  • The MHRA can inspect API sites named on marketing authorisations at any time where GMP compliance status is unknown or suspected to be deficient. Confirmation of non-compliance can result in regulatory action being taken by the MHRA."

The complete text can be found on the MHRA Webpage.

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