What is CFR Part 58?

What is CFR Part 58?

21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies. This part prescribes good laboratory practices for conducting nonclinical laboratory studies.

What does CFR 21 cover?

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

What is the regulation code for GLP?

The Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) Regulations, 21 Code of Federal Regulations (CFR) Part 58, were first issued as a draft rule on November 19, 1976 (41 FR 51206), with the final rule issued on December 22, 1978 (43 FR 59986).

Who is the single point of control for a study?

The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.

What are Good Laboratory Practice Regulations?

The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.

Is OECD principle related to GLP?

The OECD Principles of Good Laboratory Practice (GLP) ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations. The principles have been created in the context of harmonising testing procedures for the Mutual Acceptance of Data (MAD).

What does CFR Part 211 deal?

21 CFR Part 211 compliance requires the manager of any regulatory controlled manufacturing company to manufacture all medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorization and do not place patients at risk due to inadequate safety.

How do you read CFR?

Publication procedure The CFR is structured into 50 subject matter titles. Agencies are assigned chapters within these titles. The titles are broken down into chapters, parts, sections and paragraphs. For example, 42 CFR 260.11(a)(1) would be read as “title 42, part 260, section 11, paragraph (a)(1).”

How can I practice GLP?

GLP principles include

1. Organization and Personnel. Management-Responsibilities.
2. Quality assurance program. Quality Assurance Personnel.
3. Facilities. Test System Facilities.
4. Equipment, reagents and materials.
5. Test systems. Physical/Chemical.
6. Test and reference items.
7. Standard operating procedures.
8. Performance of study. Study Plan.

What are the Good Laboratory Practice GLP regulations?

How many controls are in a case?

Investigators planning case-control studies are usual- ly advised to include no more than four or five controls per case because little statistical power is gained by fur- ther increasing this ratio (1,2).