Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 4: Design and development controlPrincipleThe design and development process should be controlled to ensure that the resulting product(or service) meets the agreed specification. To achieve this the API manufacturer shouldestablish and maintain documented procedures to control and verify the design anddevelopment of the product. A plan should be prepared for each design and developmentactivity showing responsibilities and organisational interfaces with relevant communicationroutes and resources for each phase. The plan should include regular meetings to comparedesign input requirements with output results in terms of agreed acceptance criteria, i.e. designverification. Once complete, verification should be followed by design validation. Design anddevelopment (excluding research) changes should be formally controlled. The output of allreviews, verification and validation activities should be recorded. Stability testing is part of thedevelopment phase of the API as it generates evidence to support shelf-life claims.4.1 Planning4.1.1 The API manufacturer should prepare plans which describe or make reference toeach design and development activity. These plans should clearly indicateresponsibilities, organisational and technical interfaces and establish channels forclear and timely communication of relevant information.4.1.2 Planing activities should be assigned to qualified, trained and experienced personnelequipped with adequate resources.4.1.3 Plans should be updated as the design and development stage evolves.4.2 Input4.2.1 Design and development input should incorporate all relevant information, includingcontract review findings and applicable statutory and regulatory requirements.4.2.2 The design input plan should include a requirement for GMP compliance from thepoint at which the final API quality is likely to be affected, and at stages likely to bespecified in the registration documentation. Less rigorous application of GMPprinciples may be appropriate, if justifiable, at earlier stages.4.2.3 Design input should be documented and reviewed at appropriate stages (milestones)4.2.4 Ambiguous or conflicting design requirements should be resolved with thoseresponsible for imposing such requirements.18