Throughout the research arena, GLP or Good Laboratory Practice plays the role of a quality system for research laboratories and organizations. With time, GLP studies have become an integral part of the drug discovery and developmental process. These ensure consistency, uniformity, quality, reproducibility, reliability, and integrity from testing the Physico-chemical properties to chronic toxicological testing.
Applicability of the principles of good laboratory practices –
As far as the concern is about the pharmaceutical laboratories, the GLP study principles apply only to studies related to the following –
- Those that are non-clinical in origin, i.e. mostly those studies that are based on either in vitro testing or are performed on animals
- Those that are designed for generating data on both the properties and safety profiling of the pharmaceutical drug candidate under analysis
- Thus, according to the requirements mentioned under GLP lab guidelines, the following studies play a crucial role in accomplishing the below mentioned clinical studies –
- Toxicity profiling for single-dose study
- Toxicity profiling for repeated (sub-acute and chronic) dose study
- Toxicity profiling for repeated (embryo-foetal, fertility, and teratogenicity testing)
- Determination of the mutagenic potential, carcinogenic potential, toxicokinetic, and pharmacodynamic parameters of the clinical trials
Major principles under good laboratory practice –
The five significant principles mentioned under the GLP studies which must be followed by every drug manufacturing and testing entity are as follows –
Testing Facility Organization and Personnel –
The study personnel involved in the clinical trial should possess sufficient knowledge about the principles of GLP studies and where to apply them. The testing facility organization and personnel should be selected in such a way that it should –
- Record every single raw data
- Comply strictly with the SOPs
- Exercise all the essential requirements to minimize the risks or any laboratory hazards
- Helps in ensuring the integrity of the clinical study
The facilities designed for the drug development or clinical process should be of suitable size. They should be equipped with favourable manufacturing or testing requirements. It should favour an adequate separation degree to carry out a different range of drug discovery and development activities. It should facilitate easy availability of separate rooms for diagnosing, treating, and controlling the spread of diseases.
Quality Assurance Programme –
The quality assurance team involved in the process should make sure that the study plans being used and the SOPs generated are optimized according to the requirements and are all up-to-date. The verification of all the documents should be made in accordance that it complies with the norms mentioned under good laboratory practice. GLP lab studies provide a nod for three different types of inspections to check the compliance of the scheduled study with the GLP principles – study based inspection, process-based inspection, and facility-based inspection.
Test Systems –
All three forms of test systems, i.e. physical, chemical, and biological test systems, should be made available and should comply with the GLP requirements. Each one of them should provide an adequate set of information regarding source records, arrival date, and conditions.
Apparatus, Materials, and Reagents –
Apparatus, materials, and reagents being used in the manufacturing or testing system should be of adequate capacity and appropriate design. The personnel in-charge of handling these instruments should be well-versed with the facts about the document inspection, cleaning and maintenance protocol for the instruments, and apparatus calibration.