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GLP Compliance

GLP, or cGLP, stands for current Good Laboratory Practice, and is a set of regulations set forth by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) to help ensure that the processes and conditions under which laboratory studies are planned, performed, monitored, recorded and reported are are valid and high-quality.

GLP regulations describe the minimal standards for conducting nonclinical laboratory studies that support applications for research or marketing permits for products regulated by FDA or EPA such as human drugs, animal drugs, food color additives, fragrances, medical devices, biological products, and pesticide products. The regulations do not pertain to studies using humans.

GLP compliance is determined by regulatory inspections similar to those conducted to assess Good Manufacturing Practices (GMP) compliance. The main distinction between GLP and GMP is that GLPs are study-based methodologies whereas GMPs are processed-based methodologies.

Regulations

The following regulations must be applied in order for a laboratory to achieve Good Laboratory Practive GLP compliance. Note that GLP dictates that a Sponsor, Study Director, and Testing Facility Manager be selected and appointed.

A Sponsor must be selected and appointed and is required to notify the laboratory testing facility that the study must comply with GLP standards. Personnel records must be available to prove adequate training and experience for all key employees.

A Testing Facility Manager must be selected and appointed to designate the Study Director, to verify the presence of a Quality Assurance Unit, and to ensure the presence of adequate personnel, resources, facilities, equipment, materials, and practices.

A Study Director must be selected and appointed as the contact person that ensures all protocols are properly approved and followed, that all data is recorded, that GLP standards are followed, and that data, documentation, protocols, specimens, and final reports are archived.

A Quality Assurance Unit (QUA) must be appointed to ensure that facilities, personnel, practices and records are in compliance with GLP regulations, to maintain a master schedule sheet of studies, to inspect each non-clinical study to ensure compliance and to report findings to the Study Director and to the Testing Facility Manager.

All equipment must have standard operating procedures (SOPs) describing their use, maintenance, and calibration.

All testing methods must have standard operating procedures (SOPs).

All test studies must have written protocols describing the objectives and methods used for conducting the test study.

All data must be in written form, dated and initialed.

The final report by the QUA must contain a compliance statement signed by the test applicant, the Sponsor and the Study Director describing deviations from GLP standards.

GLP Data Records

GLP regulations specify what must be recorded, as follows:

Name and address of the laboratory
Name of the Sponsor
Name of the Study Director
Study title, objective and procedures
List of all control and test articles
Location where raw specimens and data are stored
Description of all methods used
Description of the test system, including frequencies
Description of all dosages, routes of administration and duration
Descriptions of data transformations and calculations used

GLP Control Articles

Control articles (also known as test articles or reference substances) are used to calibrate instrumentation. The accuracy of the control articles determines the accuracy of the analytical method used.

Main requirements for control articles are: The identity, strength, purity, composition and other characteristics should be determined for each batch and documented. * Methods of synthesis, fabrication, or derivation of test and control articles should also be documented. Copies of this documentation must be stored with the study data and must be available for FDA inspection.

The stability of each control article must also be determined. This can be done either before study start or simultaneously according to written SOPs which provide for re-analysis.

Each storage container for a control article must be labeled by name, chemical abstract number, batch number, expiration date and any storage conditions for maintaining identity, strength, purity and composition.

FDA 21 CFR Part 58

FDA 21 CFR Part 58: GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

FDA 21 CFR Part 58

Subpart A: General Provisions
Subpart B: Organization and Personnel
Subpart C: Facilities
Subpart D: Equipment
Subpart E: Testing Facilities Operation
Subpart F: Test and Control Articles
Subpart G: Protocol for the Conduct of a Non Clinical Laboratory Study
Subpart J: Records and Reports

21 CFR Part 11 - Electronic Records and Signatures
This regulation pertains to more than just GMP/cGMP and gives the requirements for electronic records, electronic signatures and handwritten signatures executed to electronic records.

FDA 21 CFR Part 111

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

Subpart A--General Provisions
Subpart B--Personnel
Subpart C--Physical Plant and Grounds
Subpart D--Equipment and Utensils
Subpart E--Requirement to Establish a Production and Process Control System
Subpart F--Production and Process Control System: Requirements for Quality Control
Subpart G--Production & Process Control System: Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement
Subpart H--Production & Process Control System: Requirements for the Master Manufacturing Record
Subpart I--Production and Process Control System: Requirements for the Batch Production Record
Subpart J--Production and Process Control System: Requirements for Laboratory Operations
Subpart K--Production and Process Control System: Requirements for Manufacturing Operations
Subpart L--Production & Process Control System: Requirements for Packaging & Labeling Operations
Subpart M--Holding and Distributing
Subpart N--Returned Dietary Supplements
Subpart O--Product Complaints
Subpart P--Records and Recordkeeping