FDA Good Laboratory Practices Guidelines for Pharmaceutical Manufacturers

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There are a number of guidelines that have been put forth by the FDA regulating good laboratory practices. These guidelines can be found in full here. However, we think that there are a few general FDA guidelines that you should be aware of no matter what your role within your organization is.

General FDA GLP Guidelines to Know

The FDA, or Food Drug Administration, has put forth a set of guidelines to monitor and ensure good laboratory practices. Title 21 of the CFR (Code of Federal Regulations) outlines these guidelines in detail. Each title within these guidelines is updated yearly.

While compliance with all guidelines is mandatory, there are some specific guidelines you should be aware of as these can impact your day-to-day operations:

  • Facility: You should be aware of the FDA guidelines for all testing facilities, including animal care facilities, animal supply facilities, facilities for handling test and control articles, laboratory operation areas, and specimen and data storage facilities.
  • Equipment: All equipment that is utilized within any testing facility must adhere to the regulations put forth in Title 21. These regulations include the design of the equipment as well as the maintenance and calibration of the equipment.
  • Personnel: Each individual operating within the testing facility must adhere to all good laboratory practices outlined by the FDA. In addition, Title 21 includes specific protocols for testing facility management, the study director, and the quality assurance unit. These protocols can be found in full detail here.

Laboratory Best Practices You Need to Follow

Here are some of the most important FDA good laboratory practices that you need to be aware of. These guidelines dictate nearly every aspect of work to ensure the optimal security and safety for all involved. From the facility you are operating in to the employees you have on staff, the FDA has set forth specific guidelines that must be adhered to. It is vital that you remain in full compliance with these guidelines at all times.

Full Facility Compliance

There are a number of lab management best practices that should be followed in the conduct of nonclinical laboratory studies.

From the facility size to the construction, there are specific facility standards that must be adhered to:

  • Animal care facilities: Each facility must be equipped with an accurate number of animal rooms and areas. In addition, there must be a separation of species and test systems, isolation of individual projects, quarantine of animals, and the routine or specialized housing of animals. In addition, separate areas must be utilized for the diagnosis, control, and treatment of laboratory animal diseases.
  • Animal supply facilities: Facilities must also be equipped with separate storage facilities for feed, bedding, supplies, and equipment. These areas must be separate from the test centers and protected against disease or contamination.
  • Facilities for handling test and control articles: The FDA guidelines for the handling of test and control articles also outline that the following tasks must contain separate areas to prevent contamination: receipt and storage of articles, mixing of test and control articles, and storage of test and control article mixtures.
  • Laboratory operation areas: For routine and specialized procedures, separate laboratory areas must be utilized.
  • Specimen and data storage facilities: All raw data and specimens must be stored in appropriate archives; access is to be limited to authorized personnel only.

Appropriate Equipment Maintenance

In addition to the facility requirements outlined above, all equipment that is utilized must be in accordance with the following guidelines (subpart D of Title 21 outlines these regulations in full):

  • Equipment design: All equipment that is used in the generation, measurement, or assessment must be of appropriate decision and adequate capacity.
  • Maintenance and calibration of equipment: Every piece of equipment must be thoroughly inspected, cleaned, and maintained. In addition, equipment that is used for the generation, measurement, or assessment of data must be adequately tested, calibrated, and standardized. Records must also be maintained at all times that include all inspections, maintenance, standardizing, or calibrating operations.

Proper Document Management

A final report must be generated for each nonclinical laboratory study. These reports must include all 14 aspects outlined here by the FDA. In addition to the information that must be included within the reports, proper record retention must also be adhered to as well. With record retention rates lasting anywhere between 2-5 years, proper document management is vital. Containing highly sensitive information and data, these documents must be secured and kept with the utmost care.

As one can imagine, there is a wealth of information at each facility that must be managed with care. In the past, this was primarily done via paper storage. However, the major problems with this type of document management are that it is often less efficient and highly susceptible to security breaches.

A Document Management Solution: eFileCabinet

Thankfully, there is a solution. No longer is paper the only option for document management; with digital document management, you can streamline your operations and ensure that only the right personnel are able to access these highly secure documents. In addition, digital document storage ensures that your facility is always in full compliance with the FDA’s record retention guidelines.

Secure, reliable, and far more efficient, eFileCabinet makes record retention a straightforward process. There is no need to worry about keeping storehouses full of paper records; with digital document storage, your files are all secured in one easy-to-access location for years to come.

Simply fill out the form on this page to request a 15-minute demo, and learn how eFileCabinet can help you follow the FDA recommendations on good laboratory practices.

By | 2016-12-15T11:59:44+00:00 October 8th, 2015|
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