The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical Report
Series No 885, 1999.
As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product.
The manufacturer of the finished pharmaceutical product is normally dependent on the manufacturer of the excipient to supply excipients meeting the required specification.
An appropriately established and implemented quality management system evaluating and controlling risks in the production and quality control of such excipients is therefore required.
Some excipient manufacturers may be required to follow good manufacturing practices for excipients used in pharmaceutical products. Reports of pharmaceutical products which contain contaminated excipients, or excipients with impurities leading to the death of patients, have further highlighted the need for a revision of the original guideline.
Furthermore, the concept of ongoing improvement, lifecycle approach, better quality management systems, risk management and management review should be described in such a guideline, alongside the necessary good storage, good trade and good distribution practices to ensure their reliability throughout the supplychain.
The manufacturer of excipients used in pharmaceutical products should be able to identify risks associated with the production (including stages of manufacturing, route of synthesis) and quality control of its products. This includes, but is not limited to,
- the premises,
- equipment,
- utilities,
- storage and distribution.
The manufacturer of such excipients should assess those risks, and identify appropriate measures to mitigate such risks. The effectiveness of the measures should be evaluated to ensure that they are appropriate.
This document provides information on good manufacturing practices that should be implemented to assist manufacturers to produce and control excipients used in pharmaceutical products that will meet their intended specifications, in a consistent manner.
Risk assessment may be useful in determining which excipients should be manufactured in accordance with this guideline.
Read also: Excipients in Pharmaceutical Applications