Whereas MAHs may use this risk assessment strategy to determine if their excipient suppliers meet the GMP requirements they define, excipient supplier may use it to understand how their customers (MAHs) establish GMP requirements for each excipient, thus allowing the excipient supplier to anticipate and provide support as applicable.
The document frequently refers to the original European Union Guideline, but does not parallel the Guidelines in its organization. It is comprised of the following sections:
- The risk assessment process
(Especially detailed and useful for those who may require a better understanding and instructions for how one might assess risk. It highlights the need to consider not only risks inherent to the excipient, but also risks from excipients suppliers and risk associated with the end used application)
- Risk mitigation activity including communication with the suppliers
- Residual risks resolution
- Triggers for risk review
Annexes which provide examples of a Process Flow Diagram, General Documentation Package or Compliance Declaration, Suitability of Risk Assessment tools, Formalised Excipient Risk Assessment References and Examples of risk scoring, have been included.
IPEC Europe notes that the EU Guidelines do not introduce any new requirements for GMP or Good Distribution Practice (GDP) for excipient suppliers or distributors who are already compliant with appropriate standards, such as the IPEC-PQG GMP Guide, EXCiPACT GMP and GDP standards or the NSF/IPEC/ANSI-363 2014 US national standard.
IPEC Americas: Insider
IPEC Europe: How-to document
Источник информации: www.gmp-publishing.com