The Active Pharmaceutical Ingredients Committee (APIC), i. e. the European association of API manufacturers, published a guideline and two templates for quality agreements in December: a template for the manufacture of so-called generic APIs and a template for the manufacture of APIs within the framework of an exclusive contract with an API manufacturer. These templates include all points that have to be regulated in such an agreement, like e. g. the right to conduct audits, the notification in case of an imminent official inspection, the keeping of retention samples and production documentation, the customer's right to examine the supplier's annual Product Quality Review, the handling of product reprocessing, deviations and out-of-specification results and many others more. Moreover, both documents include a table in which responsibilities of customer and supplier are marked by means of crosses.
Even though the two templates have the same chapters, the template for the exclusive API manufacture is adapted to the special customer-supplier relationship defined by the exclusive contract. Chapter 16 "Raw Materials" goes e. g. into great detail and describes the responsibilities of customer and supplier with regard to the procurement, handling, storage and monitoring of starting materials with considerable exactness.
In principle, these two templates cover all possible constellations of customer-supplier relationships. They are very helpful for the creation of quality agreements insofar as they provide a generally applicable basic framework that can be modified to suit the individual case and to take account of particularities in API production and of specific regulations. These templates together with the guideline are a valuable addition to the APIC publication list. Here you can download the templates as processable Word files:
Dr Gerhard Becker
On behalf of the European Compliance Academy (ECA)