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Also, the personnel training and hygiene are promoted since it is the principal 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 regulations.
Laboratory Staff:
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 to ensuring GLP and they should occasionally be trained to elevate their working standards.
Moreover, the design of the laboratory should ensure that disinfection and sterilization can easily be done to minimize the contamination risks. The good
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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.
Equipment Used:
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 of the equipment available. This ensures the measurements
and specific roles of every equipment are standardized which will not cause an overstated or understated result.
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.
Data Integrity:
Certified reference 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.
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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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