tailieunhanh - Pharmaceutical Coating Technology (Part 11)

Validation of tablet coating processes Graham SUMMARY Validation is a concept that means different things to different people. This chapter will highlight all the activities that are necessary to ensure that all aspects of the coating process are fully documented from design through to operation, to provide compliance with regulatory requirements. ‘If it hasn’t been documented, it hasn’t been done.’ FDA INTRODUCTION The FDA defines validation as: ‘Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.’ Validation has also been defined as. | Page 267 11 Validation of tablet coating processes Graham SUMMARY Validation is a concept that means different things to different people. This chapter will highlight all the activities that are necessary to ensure that all aspects of the coating process are fully documented from design through to operation to provide compliance with regulatory requirements. If it hasn t been documented it hasn t been done. FDA INTRODUCTION The FDA defines validation as Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Validation has also been defined as the activity performed to demonstrate that a given utility system process or piece of equipment does what it purports to do. The primary means of accomplishing this end is the scientific study designed to specifically permit the determination as to whether the entity under scrutiny in fact meets or exceeds the specifications of its design is properly built shipped received stored installed operated and maintained is suitable for its intended application is in accordance with principles established and generally accepted by the scientific community conforms to basic cGMP design criteria Page 268 will satisfy the concerns of regulatory bodies is capable of consistently producing a product that is fit for use will meet objectives established for productivity safety and quality. The EC has adopted very similar cGMP criteria. This scientific study is generally detailed in a validation protocol. A well-designed validation programme properly supported by senior management will accrue considerable benefit to its sponsor. Not only will regulatory obligations be fulfilled but also processes will be optimized productivity improved and downtime reduced. In short a validation programme with a sound scientific base and proper experimental design is simply good business if taken .