Current Good Manufacturing Practice requirements

Current good manufacturing practice requirements for the control of drug product containers and closures are included in 21 CFR Parts 210 and 211. The U.S. Food and Drug Administration (FDA) requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission requirements for child-resistant closures are included in 16 CFR 1700. 

Current good manufacturing practices requirements have been discussed throughout this section. The reader must... 

Current Good Manufacturing Practices [135] establish the requirements for maintaining a stability program and require that most pharmaceutical dosage forms have an established expiration date supported by test data [134]. There are few allowable exceptions. 

The current Good Manufacturing Practice (cGMP) regulations are guidelines that FDA requires a pharmaceutical manufacturer to meet. Compliance with the cGMPs is a prerequisite for the approval of NDAs, INDs, and antibiotic forms. General areas in which... 

Why do we have to worry about method validation in the first place The most compelling reason is that the law requires it. Title 21, Part 211 of the Code of Federal Regulations on Current Good Manufacturing Practice for Finished Pharmaceuticals states ... 

Record keeping is a prime requirement of current good manufacturing practices. The records required for a validated steam sterilization cycle are listed below ... 

In addition to the somewhat empirical and difficult development of NIR applications, thorough documentation must be produced. NIR methods have to comply with the current good manufacturing practice (cGMP) requirements used in the pharmaceutical industry. Various regulatory aspects have to be carefully considered. For example, NIR applications in classification, identification, or quantification require extensive model development and validation, a study of the risk impact of possible errors, a definition of model variables and measurement parameters, and... 

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