In 1962, Congress instructed the FDA to require that all drugs be produced according to Good Manufacturing Practice (GMP) which should be compliant to FDA 21 CFR Part 210-211. The move was in response to concerns about substandard drug manufacturing practices at the time, such as the use of thalidomide, a drug used in Europe to treat morning sickness, which was found to cause birth defects. The 1962 Drug Amendments brought modern quality assurance and control principles to drug manufacturing. The word "current" was later added to make it "CGMP" (or cGMP) to imply that the regulation allows for changing technology in attaining GMP.
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While 21 CFR Parts 210 and 211 both apply to GMP of drug products, each part addresses a different set of guidelines.
Subpart F, Section 211.100 – There shall be written procedures for production and process control, assuring that drug products have the intended identity, strength, quality, and purity. Written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units.
Subpart I, Section 211.160 – Any changes in specifications, procedures, sampling plans, or other laboratory control mechanisms shall be documented at the time of performance and reviewed by the appropriate organizational units.
Subpart B, Section 211.25 – Each person engaged in the manufacture, processing, packing, and holding of a drug product shall have the necessary education, training, and experience to perform the assigned functions.
Subpart J, Section 211.198 – Written procedures describing the handling of all written and oral complaints regarding a drug product shall be established and reviewed by the quality control unit.
Corrective and Preventive Action (CAPA):
Subpart J, Section 211.192 – Any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated. A written record of the investigation shall be made and shall include the conclusions and follow-up actions.
Subpart J, Section 211.180 – All records, or copies of records, shall be readily available for authorized inspection. Records shall be subject to photocopying or other means of reproduction as part of such inspection. Records that can be immediately retrieved from another location by computer or other electronic means shall be considered as meeting this requirement.
Subpart E, Section 211.84 – Each component shall be tested for conformity with all appropriate written specifications for purity, strength, and quality. Any lot of components that does not meet the specifications shall be rejected.
Compliance with the 21 CFR guidelines for pharma requires efficient management of disparate GMP functions to ensure drug products meet the requirements for safety, quality, strength, and purity. Automating quality and manufacturing management is the most effective way for pharmaceutical companies to collaboratively manage all aspects of drug product development.
MasterControl’s Quality Excellence™ solutions integrate all quality and manufacturing processes, making it easier to achieve compliance with all 21 CFR 210 and 211 requirements, including documentation, changes, training, complaints, CAPA, audits, and nonconformance.
Achieving compliance with 21 CFR Parts 210 and 211 requires strict attention to all of the GMP requirements. MasterControl equips you with all of the necessary tools to successfully meet the regulatory guidelines:
More companies are discovering that achieving compliance with 21 CFR Parts 210 and 211 is easier using automated technology. MasterControl’s Quality Excellence™ solutions have functionality that directly aligns with all of the GMP guidelines. Other benefits of using MasterControl include:
MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).