21 CFR Part 58: Mastering Good Laboratory Practice Regulations

The Code of Federal Regulations (CFR) is a monumental document dictating legal requirements across numerous fields, including the field of food and drug safety. A significant component of this regulatory landscape is the 21 CFR Part 58, a regulation addressing Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies.

Unraveling 21 CFR Part 58
Regulating nonclinical laboratory studies that support research or marketing permits for products regulated by the FDA, 21 CFR Part 58 focuses on promoting reliability, consistency, and integrity of chemical (including pharmaceuticals) and physical science testing data.

21 CFR Part 58: A Closer Look at Its Main Provisions

1. General Provisions: This outlines the scope, definitions, and applicability of the regulations, indicating that it applies to nonclinical studies intended to determine the safety of regulated products.

2. Organization and Personnel: Laboratories must have a sufficient number of personnel with the education, training, and experience necessary to perform their assigned functions.

3. Facilities: This provision ensures that the laboratory facilities are suitable in size, construction, and location to meet the requirements of testing procedures and protect the test systems.

4. Equipment: Equipment used for generating, measuring, or assessing data must be adequately tested, calibrated and maintained.

5. Testing Facility Operation: This sets forth standard operating procedures (SOPs), animal care, test and control article handling, protocol for conduct of a study, records, and reports.

6. Quality Assurance Unit (QAU): QAU is an internal function that monitors studies to ensure that they are conducted in accordance with the protocol.

Navigating the Challenges of 21 CFR Part 58 Compliance
Compliance with 21 CFR Part 58 can be complex due to the detailed and broad scope of the regulation. It requires a thorough understanding of the regulation, diligent documentation, consistent quality control and adherence to specified procedures.

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