We know that the term quality control in pharmacy has very much importance in the pharmaceutical field. It is very much necessary that the product which is being manufactured must have good quality to treat patient and the user of those product, and the responsibility of pharmacist and the pharmaceutical industry has increased.
The term quality to the product includes all factors which contribute directly as well as indirectly to achive:
- safety
- effectiveness
- and reliability of the product.
To achieve quality control a concept of Total quality control is to be appreciated:
- Which includes all the aspects starting with the procurement of raw material to the finished product available at the drug store and till it is consumed by the customer.
- It will include not only the parameters of GMP but also the storage-handling and preserving it till the ultimate use.
Some of the points of quality control:
- The quality of product must be genuine
- It must be physically and chemically pure.
- Must contain same amount of ingredients which are stated on the label
- It must be effective after administration
- Shelf life and the stability must be achieved.
The job of quality control is to check the substance for quality and quantity and in order to achieve both this parameters the standards laid down by various regulatory agencies are to be followed. The quality standards and guidelines are sometimes different in different country.
In the quantitative analysis depending upon the characteristics of the substance and its formulation various analytical methods are followed such as physicochemical methods to determine.
- Specific gravity
- Density
- Viscosity
- Surface Tension
- Refractive Index
- Optical rotation etc,
pH-potentiometry, conductometry, polarography, colorimetry, spectrophotometry, fluorimetry, flame photometry etc are made to check the above said properties.
Other methods for quantitative determination includes:
- Chromatographic method
- Gravimetric analysis
- Precipitation method
- Complex formation etc.,
Studies such as:
- Disintegration
- Hardness
- Friability
- Dissolution for tablets and related preparation
- Bioavailability studies
- Absorption-elimination studies
- Pharmacokinetic studies
- Biological and microbiological studies are also carried out.
The basis of all the studies and tests of quality control is the ensure that quality product is available to the consumer and patient.