Review on Good Documentation practice in pharmaceutical manufacturing unit as per European Union GMP Chapter-4 on Documentation

Abstract

Good documentation constitutes an essential part of the quality assurance system and is key to operating in compliance with GMP requirements. Documentation requirements of maintaining complete, accurate, truthful and verifiable data in all cGXP documents that are needed to be maintained as per regulatory requirements and various Governmental regulations, laws, rules and statutes/acts. Documentation may exist in a variety of forms, including paper-based, electronic or photographic media. Ensure that the Document should be free from error and during any point if error identify then rectify with proper reason for correcting including sign and date. A system should be in place to indicate special observations and any changes to critical data. GMP Document must have predefined retention period and document must be stored in secure and easy to retrieve or easily available as and when required. Batch Processing and Packaging Instruction must be in place and Contemporaneous entry provision must be available. Instruction and procedure for using equipment; instrument must be clear and specific. Specification with authorization should be available for analysis of Raw Material and Packing Material, Intermediate and Bulk Product, Finished Product.