As a reaction to the growing number of substandard or counterfeit active pharmaceutical ingredients (APIs) that are increasingly introduced into the supply chains, the APIC - the interest group of the European API manufacturers - created a document intended as a guideline for assessing sources of APIs. This "APIC Quick Guide for API Sourcing" bears the subtitle "APIs from legitimate and reliable sources" and is directed both at medicinal product companies and at API manufacturers. In five subject-related chapters, the document gives practical advice on the question with the help of which measures the medicinal products manufacturer as the ultimate buyer of APIs can assess the supplier's quality. Conversely, the guide also contains numerous practical recommendations for the API manufacturer, which he can implement in order to demonstrate that he manufactures his APIs in compliance with ICH Q7 or EC GMP Guide Part 2.
The following subjects are dealt with in the individual chapters:
The chapters "Audits" and "Supporting Documentation" are dealt with in great detail and include quite practice-oriented tips, e. g. the recommendation to auditors to change the agenda at short notice and to re-inspect areas that have already been looked at in order to uncover scenarios that may have been created artificially. As another important point to get an overall picture of the audited site, the text mentions the Product Quality Review which gives the auditor a good overview of the GMP-compliant manufacture of an API.
What is important according to the APIC Quick Guide, is good and intense communication structures between the medicinal product manufacturer and the API supplier. There is an explicit reference to the topic of packaging, labelling and tamper-resistant closures. The API manufacturer should supply his customers with samples of the used labels and closures so that counterfeits can be spotted unmistakeably and quickly.
With its up-to-date and practical recommendations, the "APIC Quick Guide" represents an ideal complement to APIC's recently revised "How-to-do" document, which interprets the ICH Q7 guideline. However, the introductory chapter of the guide points out that these recommendations should be understood as elements of a jigsaw puzzle within the framework of a comprehensive supplier qualification, i. e. a risk-based reflection does have to be undertaken in advance in order to determine the reasonableness of the individual measures - depending on the API supplier in question. The Procurement of GMP-compliant APIs is also the topic of a conference with major stakeholders from industry and authority in Brussels, Belgium, on 13 - 14 March 2009.
The "APIC Quick Guide" can be found here.
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)