Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 6: PurchasingPrinciplePurchased product and service should conform to clear and concise specified requirements.There should be mechanisms in place for evaluating sub-contractors, agreeing purchasing data,and verifying the quality of purchased product.6.1 Evaluation of suppliers6.1.1 There should be a system in place for qualification of suppliers.6.1.2 Suppliers may be approved on the basis of one or more factors such as historicalexperience, quality audit, third party certification etc., bearing in mind the nature ofthe purchase and its likely impact on final product quality.6.1.3 A list of approved suppliers should be supported by appropriate records reflectingperformance in terms of quality, delivery, cost-benefit etc. of each supplier.6.2 Purchasing data6.2.1 There should be a written and approved contract between supplier and APImanufacturer, which clearly states the responsibilities of each party. The scope of,and level of details within, the contract may be dependent upon the significance ofthe purchase in relation to the quality of the final API.6.2.2 Purchasing documents should contain data clearly describing the product ordered,including where applicable:- product identification, including grade or special requirements.- the applicable specifications as well as any additional quality system document orSOP that would apply to the goods when received- changes planned by the supplier of purchased goods6.2.3 Purchasing documents should be reviewed and approved for accuracy of specifiedrequirements prior to use.24