Quality control is very much important in pharmaceutical industry. Doctors always need a good quality product for treatment. Pharmacist and pharmaceutical industry is responsible for delivering good quality product. All the factors which contribute either directly or indirectly to the purity, safety, effectiveness and reliability of the product will be included under the term 'quality'. To achieve all these characters there is need to undertake quality control. A typical total quality control starts from the procurement of raw materials to the finished product until it gets consumed by the patient. When a drug is administered to the patient it should not show any undesirable/toxic effects.
- Quality control ensures that a drug will have the following characteristics:
- Genuine Quality as well as good nature
- Physically and chemically pure
- It contains same amount of ingredients as mentioned on the label
- It must be in such a form that after administration it is effective
- Quality in terms of shelf life/stability
- No toxic impurities
The drug is tested for both quality as well quantity by the quality control department. Every country will have an official pharmacopoeia which will give the standards of quality for all the medicines along with the methods to be used for quality control. Revised supplements are published periodically to stay up-to-date pertaining to drug quality.
Every test or criterion that is prescribed as a standard in the pharmacopoeia is a parameter. (E.g. Assay, solubility, limit test for arsenic). The number of parameters indicates the rigidness of the standard and reliability. However we do not need too many parameters. To ensure good quality few critical and important parameters are enough. Too many parameters lead to confusion, tedious analytical process and also increase the cost of production. In order to avoid these problems pharmacopoeia will select some critical tests and prescribes them.
Quantitative analysis depends on the drug characteristic and its formulation. The analytical methods include some physicochemical methods. The other methods include separational techniques.
The basis of all these tests is to ensure that quality drug is made available to the patient.
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- "Pharmaceutical Chemistry-Inorganic", G.R. Chatwal, Volume 1, 2007, pg 27, 28, 29
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