17 Ensuring Drug QualityBrenda.ppt

* Audit/ Review Annual Product Review Regular trending reviews and evaluation of process and product Evaluation of stability, recalls, OOS, product complaints, returns Risk assessment, mitigation before occurrence of serious consequences Ensure operation is maintained in an ongoing state of control Knowledge gained for continuous improvement in product life cycle * Contract Agreement Clear contractual agreements on: Responsibilities of each party Effective communication on all issues that potentially impact drug quality Adequate qualification, auditing and regular periodic evaluations of contractors Notification to FDA for changes in contractors * Document Controls A most critical element to support acceptability of a production batch and GMP compliance Not just a bureaucratic exercise to satisfy FDA REQUIRE ORIGINAL RECORDS as the task (operation) is being performed, not a re-copying of the original. Data must not be altered Production: batch records QC: testing records Violations: Serious Consequences * Documentation All SOP (especially production batch record) should be in sufficient detail for the operator to carry out the task in a consistent manner Changes in SOP must be reviewed and approved by QA * Material Management * Material Controls Raw materials Intermediates Components API Manufacturing materials e.g., sterilizing filters Facility materials e.g., HEPA filters * ICH Q7A: Materials Management Manufacturers of intermediates and/or API should have a system for evaluating the suppliers of critical material Materials should be purchased against an agreed specification, from a suppliers, approved by the quality unit(s) If the supplier of a critical material is not the manufacturer of that material, the name and address of that manufacturer should be known by the intermediate and/or API manufacturer. Changing the source of supply of critical raw materials should be treated according to Section 13, Change Control. * Equipment Management * Qual