Documentation: Records and Reports. 2017

Michael J Akers
Baxter BioPharma Solutions, Bloomington, Indiana. mjakers356@gmail.com.

This article deals with documentation to include the beginning of documentation, the requirements of Good Manufacturing Practice reports and records, and the steps that can be taken to minimize Good Manufacturing Practice documentation problems. It is important to remember that documentation for 503a compounding involves the Formulation Record, Compounding Record, Standard Operating Procedures, Safety Data Sheets, etc. For 503b outsourcing facilities, compliance with Current Good Manufacturing Practices is required, so this article is applicable to them. For 503a pharmacies, one can see the development and modification of Good Manufacturing Practice and even observe changes as they are occurring in 503a documentation requirements and anticipate that changes will probably continue to occur.

UI MeSH Term Description Entries
D004282 Documentation Systematic organization, storage, retrieval, and dissemination of specialized information, especially of a scientific or technical nature (From ALA Glossary of Library and Information Science, 1983). It often involves authenticating or validating information. Documentations
D004335 Drug and Narcotic Control Control of drug and narcotic use by international agreement, or by institutional systems for handling prescribed drugs. This includes regulations concerned with the manufacturing, dispensing, approval (DRUG APPROVAL), and marketing of drugs. Drug Regulations,Narcotic Control,Pharmaceutical Policy,Drug Control,Narcotic and Drug Control,Pharmaceutic Policy,Control, Drug,Control, Narcotic,Controls, Drug,Controls, Narcotic,Drug Controls,Drug Regulation,Narcotic Controls,Pharmaceutical Policies,Policies, Pharmaceutical,Policy, Pharmaceutical,Regulation, Drug,Regulations, Drug
D004339 Drug Compounding The preparation, mixing, and assembly of a drug. (From Remington, The Science and Practice of Pharmacy, 19th ed, p1814). Drug Formulation,Drug Preparation,Drug Microencapsulation,Pharmaceutical Formulation,Compounding, Drug,Formulation, Drug,Formulation, Pharmaceutical,Microencapsulation, Drug,Preparation, Drug
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D017408 Guidelines as Topic Works about a systematic statement of policy rules or principles. Guidelines may be developed by government agencies at any level, institutions, professional societies, governing boards, or by convening expert panels. For guidelines in the field of health care and clinical medicine, PRACTICE GUIDELINES AS TOPIC is available. Guidelines as Topics

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