EMEA to Update GMP Guide With Starting Materials Section
The European Medicines Agency (EMEA) plans to update Chapter 5 of its GMP Guide to reflect the agency’s requirements that active substances and certain excipients, also known as “starting materials” used as components for pharmaceutical products, be manufactured according to good manufacturing practices (GMPs).
Under the EMEA Ad Hoc GMP Inspection Services Group’s (GISG) proposed timetable for publication, the consultation will be released in late September with a deadline for comments in March 2008.
“Although [Chapter 5] does provide some guidance on the qualification of suppliers, it does not emphasize the obligation to ensure that active substances are produced in accordance with GMP,” the EMEA said.
Special attention will likely be given to the traceability and confirmation of the origin of active substances, the EMEA said. In addition, testing of starting materials will be detailed in a new section of the GMP Guide.
“Some member states require the manufacturer to test starting materials itself while others permit the use of certificates of analysis provided by the supplier. A harmonized approach, taking into account principles of quality risk management, is desirable [for] striking a balance between assurance of quality … and the efficient use of resources,” the EMEA said.
Testing harmonization of starting materials is not expected to have a negative effect in industry. In fact, the GISG said, the update “should help some manufacturers use existing resources in a more effective way.” The EMEA added that the revision should bring clarity and transparency into this area of GMP to the benefit of both industry and inspectors.