Good Manufacturing Practice (GMP) is a process that ensures that products that are produced by pharmaceutical companies are of quality standards. The GMP is incorporated in the system of production and this result in the minimization or elimination of risks of the final products produced. GMP is integrated into all sequences of production from the raw materials, the premises design, to the equipment used. Also, the personnel training and hygiene are promoted since it is the principle contributor to GMP. Detailed and documented procedures are vital for the finished pharmaceutical products to be of quality.
A pharmaceutical microbial laboratory is mostly associated with three primary tests. Firstly, they are involved in sterility tests. Secondly, there is identification, detection, isolation and quantification of the microbial organisms. Finally, assays are done using microbial agents as test systems. Good practice in a laboratory is known as GLP. For the GLP process to be facilitated effectively there are diverse facets that will be considered supremely. The staff, environment, test method validation, equipment used, reagents and media used and referencing to international standards are the key aspects of GLP.
The management should recruit qualified and experienced people to work in the microbial laboratory. The workforce to be instituted in the laboratory should have the expertise to operate equipment and perform different tests. For example, the staff should have skills for the colony counting, plate pouring, preparation of media, aseptic techniques and identification procedure.
Moreover, the personnel should have a good practice in containment and disposal of microorganisms while they work in the laboratory. It is important to note that the laboratory staff is the primary contributors of ensuring GLP and they should occasionally be trained to elevate their working standards.
Environment of Laboratory:
The microbial laboratory and its equipment should be separated from the area of production. The separation is necessary since contamination, cross-contamination and mix-ups are avoided. Therefore, there should be an adequate and suitable space provided where samples, media, reference organisms can be comfortably handled.
Moreover, the design of the laboratory should ensure that disinfection and sterilization can easily be done to minimize the contamination risks. The good laboratory practices should be enforced to ensure that standard products are produced. For instance, the microbial laboratory should only be authorized to its personnel, each area in the laboratory should be used for the intended purpose, and various containment levels should be put in place.
Test Method Validation:
All tests to be done under the laboratory should be standardized. The verification of the method is important since it ensures there is the existence of both the negative and positive controls. These controls are vital in determining whether the tests performed are valid or not. Once the methods used to verify the quality of products are validated so are the results and recommendations adopted.
Each instrument, device or apparatus used for analysis should be calibrated and verified while ensuring good laboratory practice in a pharmaceutical laboratory. The laboratory should always maintain a qualification and performance verification for the equipment available. This ensures the measurements and specific roles of every equipment are standardized which will not cause an overstated or understated result.
Reagents and Media:
Reagents and media used in the laboratory should be of good quality. Usually, the reagents suitability for the various tests are taken into account, and specific batches are procured. Media to be used is either prepared by the staff or purchased ready for use. However, purchased media should be tested if they are suitable for use. It is best practice if the shelf-life, labeling, and the date are noted when the reagents and media are opened. This will ensure that the uses of reagents and media are well monitored to avoid sub-standard results.
Certified referencing materials are majorly used by microbial laboratories to verify, qualify and calibrate equipment. Also, the referencing can be used to ascertain the validity of a process and tests were done. Microbial reference cultures used for positive controls should be of international standards and should be maintained properly.
In conclusion, products produced in the pharmaceutical companies are usually used by the majority of people for therapeutic purposes. The quality of the products remains the essential aspect of promoting and enhancing health to the users of the final products. Good Laboratory Practices lay the foundation for ensuring that the standards are attained although the pharmaceutical laboratory practices. By making sure that the staff, equipment, environment, reagents and media and referencing are well instituted, this will collectively result in good laboratory practices.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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