IPEC has completed an updated version of the IPEC-PQG GMP Guide and the IPEC GDP Guide, bringing the documents fully in line with the latest thinking on Good Manufacturing Practice and Good Distribution Practice requirements for pharmaceutical excipients. 

Excipients have a wide range of applications and are essential components of the drug product formulation. Excipients play a critical role in the manufacture of medicines by helping to preserve the efficacy, safety, and stability of active pharmaceutical ingredients (APIs), and help to ensure that they deliver their promised benefits to patients. Therefore the quality of excipients is critical to assure the safety, quality and efficacy of medicines.

The new 2017 versions of the IPEC-PQG GMP Guide and the IPEC GDP Guide replace the 2006 editions. While the fundamental principles of GMP have not changed in the intervening period, there have been important changes in the way adherence to GMP should be achieved.

While the fundamental principles of GMP have not changed in the intervening period, there have been important changes in the way adherence to GMP should be achieved. In particular, there is an increased regulatory emphasis on risk-assessment that a pharmaceutical manufacturers to carry out. This risk assessment thinking should also be applied by Excipient manufacturers as they implement GMP.

The guide also needed to be updated to take into account the EXCiPACT standard, against which excipient suppliers can be certified to provide assurance that they are operating in conformance with excipient GMP.

The GDP Guide has been updated to provide guidance for those companies involved in the supply chain of pharmaceutical excipients and addresses more recent developments where an increasing emphasis is placed on risk and quality management.

IPEC has also published the first version of the IPEC Risk Assessment Guide for Pharmaceutical Excipients (RAG) to provide a systematic and scientifically sound methodology for the evaluation of risk to excipient quality and to facilitate more effective and consistent risk-based decisions by excipient makers, distributors, and users.

Guidance is provided herein on “HOW TO” conduct a risk assessment from the perspective of an excipient manufacturer or distributor. The guide provides an overview of: 1) quality risk management, 2) the scientific principles of risk identification and assessment and 3) an outline of the process and use of appropriate risk assessment methodologies.

IPEC will also publish soon the updated version the IPEC Quality Agreement Guide & Template designed to provide excipient users and suppliers a common starting point to create quality agreements that address fundamental quality issues specific to the manufacture and use of excipients.