PIC/S Guidelines on Excipient GMP Risk Assessment

The present PIC/S Guidelines is based on EC document 2015/C 95/02, and has been adopted by PIC/S as a guidance document. It is up to each PIC/S Participating Authority to decide whether it should become a legally-binding standard. PIC/S Participating authorities are listed on the PIC/S website.

The manufacturing authorisation holder is required to ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice (GMP) is. The appropriate GMP for excipients of medicinal products for human use shall be ascertained on the basis of a formalised risk assessment in accordance with these guidelines. The risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The manufacturing authorisation holder shall ensure that the appropriate GMP ascertained is applied. The manufacturing authorisation holder shall document the measures taken. The excipient risk assessment/risk management procedure should be incorporated in the pharmaceutical quality system of the manufacturing authorisation holder. Manufacturing authorisation holders should have the risk assessment/management documentation for appropriate GMP for excipients available on site for review by GMP inspectors. Consideration should be given to sharing relevant information from the risk assessment with the excipient manufacturer to facilitate continuous improvement. A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use in accordance with provisions established by applicable national competent authorities.

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