Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued

The EU Commission has issued Guidelines for the risk evaluation of pharmaceutical excipients for consultation - fulfilling the request from the Directive 2011/83/EC, Article 47 which says:

"The principles of good manufacturing practice for active substances used as starting materials referred to in point (f) of Article 46 shall be adopted in the form of detailed guidelines."

The three Guidelines with the titles

  • Determination of appropriate GMP based on type of excipient 
  • Determination of Excipient Manufacturer's Risk Profile 
  • Confirmation of Application of Appropriate GMP

were not issued separately, but are comprised in one document entitled "Guidelines on the formalised risk assessment for ascertaining the appropriate Good Manufacturing Practice for excipients of medicinal products for human use".

The first Guideline "Determination of appropriate GMP based on type of excipients" initially refers on the ICH Q9 Guide "Quality Risk Management" incorporated in Part III of the EU GMP Guide. The quality risk management principles described there are also to be applied to pharmaceutical excipients. In addition the new Guideline contains specific criteria for the risk evaluation in regard to

  • The origin of the excipient 
  • The dosage form and use of the medicinal product in which it is used

Finally the Guideline lists a number of GMP principles that have to be followed by the excipient manufacturer at minimum.

The second Guideline "Determination of Excipient Manufacturer's Risk Profile" requires the creation of a weak point analysis based on data e.g. from audits at the API manufacturer. It also has to be considered whether the excipient manufacturer is accredited or whether his QM system is certified. Based on the risk profile determined an appropriate control strategy has to be established.

The last Guideline "Confirmation of Application of Appropriate GMP" requires a permanent examination of the excipient's and manufacturer's risk profile. For that purpose the Guideline provides the following 5 observation criteria:

  • Number of quality defects in excipient batches 
  • Type and severity of the defects 
  • Loss of accreditation at the excipient manufacturer 
  • Trends at the quality attributes of the medicinal product (depending on nature and role of the excipient in the dosage form) 
  • Audit (re-Audit) at the excipient manufacturer

The document "Guidelines on the formalised risk assessment..." with the Guideline drafts is available on the EU Commission's News site of the EU Commission - open for consultation until 30 April 2013. Here you will get directly to the document.

The implementation of the new requirements will be covered at an ECA training course on GMP and GDP for Pharmaceutical Excipients in Prague.

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