Pharmaceutical labs play an important role in pharmaceutical production and quality control of drugs. Testing and certification of drugs and their raw materials are done in these labs before administering the drugs in humans to treat diseases. Methods are developed and validated for raw materials and also for finished products in the pharmaceutical labs.
What kinds of lab tests are performed in pharmaceutical labs?
- Testing of raw materials
- Testing of finished products or drugs
- Validation of methods undertaken for drug production
- Stability testing
- Development of analytical methods including statistical analysis
- Microbiological assays
- X-ray diffraction testing
- Specialty services
The life cycle of drug development in pharmaceutical labs
Discovery and Development of drugs- Research are carried out for different health problems and solutions to the problems are found after extensive research work.
Pre-clinical research- Determination of the toxic properties, pharmacokinetic information, and efficacy is done.
Clinical Development- pharmaceutical labs are of the most important here as clinical trials are conducted here on healthy volunteers to calibrate it for final human usage.
Review and approval of drugs- Reports obtained from clinical trials are forwarded to regulatory bodies of the country that is governed by the government for final approval.
The process of the pharmaceutical lab inspection encompasses the comprehensive evaluation of the entire lab including the people that work in the lab and the raw materials being used in the making of the medicines. The following aspects are taken care of in this process:
- The methodologies to be used for testing a new drug
- Assessing if the pharmaceutical lab has conformance with that of Good Manufacturing Practices or GMP
- Aspects of operations of the pharmaceutical lab
Concept of GMP
Good Manufacturing Practice is a system to ascertain that the pharmaceutical items are produced consistently from the lab and that there is proper quality control. The standards are designed in such a way that the risks are minimized.
Concept of Good Laboratory Practice (GLP)
GLP should be followed in any pharmaceutical lab which is as follows:
Pharmaceutical labs should have the proper infrastructure to support all the required Quality Control tests and examinations.
- Labs should be in close association with the Mfg. Department but at a safe distance so as to avoid dust, pollution, vibration, and traffic in order to protect the delicate instruments.
- Separate wings should be formed for sterilization, microbiological tests, and instruments for analysis. All these wings should have an interconnection with the internal door.
- The Airlock system must be effective and provisions must be there for the air conditioner and fumigation chamber respectively.
- Adequate space must be there and there must be provisions for utilizing water properly, solvent storage, collection of extracted dust, etc.
- Lab furniture must be so designed that they have adaptable.
- The tabletop must be resistant to acids, alkalis, and solvents.
- The floor of the lab must have a good drainage system and has to be smooth and easy to clean.
3 Es in Quality Control
- Effectiveness- The planning of lab activities should be done in such a way that aims are achieved.
- Efficiency- It is the relation between resources used and final results.
- Excellence- Working with sincerity and accuracy.
Pharmaceutical Industry of Australia: Statistics and Facts
The market has been growing steadily over the last few decades even after facing the present global challenge of the Coronavirus pandemic. Whole sellers and retailers of the Australian pharmaceutical industry serve as the base of operation for several international pharmaceutical companies and biotechnology industries. A few important facts about the Australian pharmaceutical industry are:
- The most commonly prescribed drug- Atorvastatin
- Percentage of patients who take medications from prescription – 67.5%
- Total number of pharmacies- 5715
Pharmaceutical labs must follow the above-mentioned procedures strictly as human lives are associated with their sincerity.