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Good Manufacturing Practice (GMP) is a process that ensures that products manufactured by pharmaceutical companies are of quality. GMP is incorporated into the production system and thereby minimizes or eliminates risks in the final product produced. GMP is integrated in all stages of production from raw materials to premises design, machinery used.
Also, employee training and hygiene are promoted as these are major contributors to GMP. Detailed and documented procedures are critical to the quality of the finished pharmaceutical product.
A pharmaceutical microbial laboratory is mostly associated with three primary tests. First, they involve infertility testing. Second, there is the detection, identification, isolation and quantification of microbial organisms. Finally, assays are performed using microbial agents as test methods. Good practice in a laboratory is known as GLP. There are various aspects that will be given utmost consideration to effectively facilitate the GLP process. Staff, environment, validation of test methods, equipment used, reagents and media used and reference to international standards are key aspects of GLP regulations.
Laboratory Staff:
Management should appoint qualified and experienced people to work in microbial laboratory. The staff employed in the laboratory should have the skills to operate the equipment and perform various tests. For example, staff must have skills in colony counting, plate pouring, media preparation, aseptic techniques, and detection procedures.
In addition, personnel should practice a good practice for the control and disposal of microorganisms while working in the laboratory. It is important to note that laboratory personnel are primary contributors to ensuring GLP and should be trained occasionally to improve the quality of their work.
Laboratory environment:
Microbial laboratories and their equipment should be separated from production areas. Segregation is necessary to avoid contamination, cross-contamination and mix-ups. Therefore, an adequate and appropriate space should be provided where samples, media, reference organisms can be handled comfortably.
Furthermore, the design of the laboratory should ensure that disinfection and sterilization can be easily performed to reduce the risk of contamination. Good laboratory practices should be implemented to ensure that quality products are produced. For example, the microbial laboratory should be authorized only to its personnel, each area of the laboratory should be used for its intended purpose, and different containment levels should be established.
Test Method Validation:
All tests done in the laboratory should be standardized. Method validation is important because it ensures that both negative and positive controls exist. These controls are important to determine whether the tests performed are valid or not. The results and recommendations are accepted when the methods used to verify product quality are verified.
Equipment used:
Every instrument, instrument or apparatus used for analysis should be calibrated and verified while ensuring good laboratory practice in pharmaceutical laboratories. The laboratory should always maintain a qualification and performance verification of available equipment. This ensures that the measurements and specific roles of each tool are standardized which will not cause an overestimated or underestimated result.
Reagents and Media:
The reagents and media used in the laboratory should be of good quality. Generally, suitability of reagents for different tests is taken into consideration and specific batches are collected. The media used are either prepared by the staff or purchased ready for use.
However, the purchased media should be checked for suitability for use. It is best practice if shelf-life, labeling, and date are noted when reagents and media are opened. This will ensure that the use of reagents and media is well monitored to avoid sub-standard results.
Data Integrity:
Certified reference materials are mainly used by microbial laboratories to verify, qualify and calibrate equipment. Also, referencing can be used to confirm the validity of a process and was tested. Microbial reference cultures used for positive controls should be of international standards and properly maintained.
In conclusion, products produced by pharmaceutical companies are generally used by most people for therapeutic purposes. Product quality remains an essential aspect of promoting and improving the health of end product users.
Good laboratory practices form the basis for ensuring that standards are achieved throughout pharmaceutical laboratory practice. By ensuring that personnel, equipment, environment, reagents and media and referencing are well established, this will collectively result in good laboratory practice.
