Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 3: Contract reviewPrincipleThe API manufacturer should establish and maintain procedures, involving clear lines ofcommunication, to ensure that customer requirements are understood, documented and agreed.This should include confirmation that the API manufacturer has the capability to meet thecustomer’s requirements. Subsequent changes to the agreed contract should be adequatelycontrolled.3.1 Contract3.1.1 In this context the term 'contract' usually applies to the agreement between the APImanufacturer and the (downstream) customer.3.1.2 The API manufacturer should establish a written contract containing all the customerorder requirements.3.1.3 Any differences of understanding between the API manufacturer and the customershould be resolved before the contract is signed.3.1.4 The contract should take into consideration current regulatory and legislativerequirements relevant to both the country of manufacture and the country (orcountries) of intended use. It should also indicate to what degree manufacture and/ortesting is to be subcontracted.3.1.5 Some examples of items which should be considered in a contract are listed below:* Right of inspections* Materials purchasing* Testing and release of materials* In-process control (IPC)* Calibration, qualification and validation activities* Process Changes* Storage of samples* Quality Function responsibilities* Packaging, labelling, transport and storage* Handling of complaints and recalls* Archiving of records and documentation* Subcontracting16