Good Laboratory Practices

The knowledge gained over a long period of time in the establishment of a system of Good laboratory practices in pharmaceuticals industry is highlighted with respect to some specification like design, location, equipment, chemicals and mixing chemicals, reports and auditing.

The laboratory should be located, designed, customised to meet the performance required by all quality control and analytical requirement.

Although good laboratory practices in pharmaceuticals require that the laboratory should be well located to accommodate the manufacturing department, the two should be separate to avoid dust, vibration and internal and external traffic of people working there.

Separate wings should be there for microbiology and sterility, analytical, instruments and they should be interconnected.

Good laboratory practices in pharmaceuticals require also that good air circulation be made and that involved fumigation chamber. Also, space, water, utility, solvent storage and extraction dust collection that is well covered is needed.

In addition to the effective airlock, laboratory furniture so designed to cater for any change and the top part of the table must be covered properly and being resistant to alkali, acids, and solvent.

Lastly, on this section, the floor surface should be smooth and easy to clean. Adequate drainage facility to be built.

A written standard procedure that is on use for every instrument.

Adequate space at a separate room for instruments should be created and it should be under controlled temperatures. Cleaning and handling of equipment done under care.

Maintenance and calibration service to be stored always done at an interval time.

Glassware for example that is used in measuring must be calibrated and certified before use.

Instructions regarding handling, operating operation be displayed near the instruments.

Overloading of electricity system must be eliminated and adequate lighting provided.

The stabilizer instrument for voltage should protect delicate instruments.

Proper labeling of usage containers of chemicals must be done.

During transferring of chemicals, it must be done with care. The alway usable solutions labeling to be done.

It is a very important factor of Good Laboratory practice in pharmaceuticals. The information is recorded for purpose of future reference.

Documents that are always required are the logbook for usage, protocols, maintenance and calibration of equipment.

All the performed test as a record and also the graph must be stored with the raw data.

The authorized personnel must be the only ones that control and access the records and reports. This assist in quick referencing since if many people are involved, misplacement may be made.

The people that must be authorized at the laboratory must meet the education qualification, trained and have the required experience to complete any task that arises or required in the laboratory.

There must be a sufficient number of people working in different areas within the laboratory.

The appropriate clothing to suit their requirement should be of the present environment. The one that prevents chemical combination and microbiology.

A good and durable equipment extinguishing should be identified and bought or placed at a strategic area.

All the people involved in testing require antidote in case of an accident that may occur.

All these considerations for good laboratory practice in pharmaceuticals when followed to the latter, then its daily operation will be up to the standard.

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