Prepare guidelines for the periodic review of documents. Ensure that current industry practices and pharmacopoeia requirements are met by current versions of documents Written records should be kept so that data can be used to assess the quality standards of each drug at least annually to determine whether changes to drug specifications or manufacturing or control procedures are required. Written procedures should be established and followed for such assessments, including provisions on: When electronic signatures are used for documents, they must be authenticated and secured. Batch records: These documents are typically used and completed by the manufacturing department. Batch logs provide step-by-step instructions for production-related tasks and activities and include areas in the batch record itself to document these tasks. The local quality assurance unit is responsible for ensuring, through organizational measures and audits, that the GMP documentation and records systems used within the business unit are complete and comply with relevant GMP requirements, as well as that SOP requirements are met. Prepare Apex documents such as quality guidelines, quality guide, site root file, validation blueprint, etc. describe management`s quality commitments Prior to the commencement of treatment, a review should be conducted and documented to ensure that the equipment and workplace are free of previous products, documents or materials that are not required for the intended process and that the equipment is clean and fit for use. Documents must have unique content.

The title, nature and purpose must be clearly indicated. They must be carefully arranged and easy to check. The documents reproduced must be clear and legible. The following gates/checklists can help assess the compliance of “documentation and records” with GMP requirements. One of GDP`s main objectives is to protect public health and safety by preventing falsified, illegal or substandard medicines from entering the market. SOPs for change control, process or document review, or facility or equipment upgrades should be guided by impact assessment and change control procedures In the United States, GxP regulations are enforced by the U.S. Food and Drug Administration (FDA) and are included in Title 21 of the Code of Federal Regulations (21 CFR). In 21 CFR, Part 11 includes requirements for computer systems that create, modify, maintain, archive, retrieve or distribute electronic records and electronic signatures to support GxP-regulated activities. Part 11 was created to enable the adoption of new information technologies by FDA-regulated life sciences organizations while providing a framework to ensure that electronic GxP data is reliable and trustworthy. Test methods: These documents are usually used and completed by the Quality Control (QC) department. Test methods provide step-by-step guidance for testing consumables, materials, products, and other production-related tasks and activities, such as environmental monitoring of the GMP facility.

Provisions for the preparation, revision and distribution of documents The following documents and procedures must be prepared to meet the above requirements. The data generated by these procedures should be retained to demonstrate compliance with the above requirements. In the food, pharmaceutical and medical device industries, it is essential that good practices are in place to ensure controlled and consistent performance. it is an integral part of GMP. Procedures should be clear, concise and logical. Consider hiring a professional technical writer to do the job. Unlike permanent employees, they know how to write well and perform usability testing to make sure documents work. Independent review of the process can also help improve the process. Batch production records should be established for each intermediate and API/formulation and should contain complete information on the manufacture and control of each batch.

The batch production protocol should be checked prior to issuance to ensure that it is the correct version and a legible and accurate reproduction of the corresponding standard production instructions. If the batch production record is created from a separate part of the master document, the batch production record must contain a reference to the current master production instruction used.