Good Control Laboratory Practices

In order to achieve reliable results, Quality Control laboratories should have sufficient resources and appropriate facilities, with properly trained, managed and motivated staff, and adopt good quality control laboratory practices. Materials and products should not be released for use or supply until their quality has been judged satisfactory. Quality Control should be independent from Production. Quality Control should adopt procedures necessary to ensure that the relevant tests and checks are carried out... 

GLP must not be confused with that part of GMP that is concerned with operations in QC laboratories that assure the quality of medicines for human use (sometimes referred to as good quality control laboratory practice). Although there are a number of similarities in the practical aspects, GLP is in place to assure the integrity and quality of data GMP is there to assure the quality of the product, i.e. its conformance to specification. There have been a number of statements recently from FDA sources on this subject [10]. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

The reviewer should estabHsh that the laboratory reporting the study has the necessary professional reputation, scientific experience, and expertise in the area investigated. It should be confirmed that adequate quaHty-control faciHties are in place and good laboratory practices and procedures foUowed. 

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

FDA resources are expended in areas based not on their absolute importance but on the lack of industry capability to control a particular concern. When manufacturing processes were primitive, unclean, and uncontrolled, the FDA issued the Good Manufacturing Practices and eventually the Good Laboratory Practices, Good Clinical Practices, and Good Tissue Practices. Together these Practices provide standards for the industry operations. 

Analytical chemistry is a critical component of worker safety, re-entry, and other related studies intended to assess the risk to humans during and subsequent to pesticide applications. The analytical aspect takes on added significance when such studies are intended for submission to the U.S. Environmental Protection Agency and/or other regulatory authorities and are thus required to be conducted according to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Good Laboratory Practice (GLP) Standards, or their equivalent. This presentation will address test, control, and reference substance characterization, use-dilution (tank mix) verification, and specimen (exposure matrix sample) analyses from the perspective of GLP Standards requirements. 

Chemists whose work is characterized by good laboratory practice will work in such a way that they make sure they fully understand what it is they have to do before they begin work. They will always be in control of their actions. 

Consider the risks - are they covered by general good laboratory practice, or are more rigorous controls necessary (e.g., COSHH) ... 

Experimental use of animals is controlled under Good Laboratory Practice (GLP), and study protocols are submitted to the Animal Research Ethics Committee for approval. Studies using animals can only proceed with the approval of the Ethics Committee, which consists of technical personnel. 

For TM to be accepted into mainstream medical treatment, a likely scenario is the application of scientific methodologies and controls for TM development, evaluation, and production. Many of the tools for high throughput screening (HTS) and assay systems can be used to test the efficacy of TM, similar to the irrational approach of screening natural products. Pharmacology studies have to be conducted in accordance with Good Laboratory Practice (GLP). 

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