In this article, I will discuss the role of quality control in the Pharmaceutical industry.
What is Quality Control in the pharmaceutical industry?
Quality Control is a key department of the pharmaceutical industry. I have been working in the pharmaceutical industry for the last seven years and I know how much Quality of a product and system depends on the quality control department.
Quality Control in a pharmaceutical industry refers to a sum of all the procedures to ensure the identity and purity of the product, procedure, method or system. It consists of all the attributes which decide whether the product meets all the specified standards or not.
Quality control does not only concerned with the quality of active substance (API) but it also covers other factors such as excipients and product development procedure. Quality Control is responsible for all chemical testing parameters and procedures right from receiving of Raw material to the finished good.
Quality Control and Good Laboratory Practice (GLP) are a set of guidelines to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical and pharmaceutical products. These guidelines were made public in FDA’s publication of Proposed Regulations on GLP in 1976, with the establishment of the Final Rule in June 1979.
Good Laboratory Practice in Quality Control Department
According to these guidelines, quality control in the pharmaceutical industry has to follow some rules and regulations. Quality control is responsible to follow standard operating procedures. There is a developed procedure for every operation of instrument and equipment.
We have made SOPs regarding the operation of UV Spectrophotometry, High-performance liquid chromatography HPLC, pH meter, FTIR and similarly other instruments. Not only this, SOPs for precautionary measures and handling of chemicals are also followed.
The safety of personals is a prime priority. In the quality control laboratory, we have made sure that proper precautions are taken while handling glassware, chemicals or hazardous material. It is a very important part of GLP. Use of safety goggles, mask, gloves, respiratory protection equipment, fuming hood and availability of first aid box is necessary to do work in the Quality Control laboratory. Chemicals and reagents must be present in proper containers, at a proper place with proper identification.
International Pharmacopoeia and reference standard
In the department of quality control in the pharmaceutical industry, the procedures which are used to test material or product must present in monographs, and international reference standard (USP, BP, BNF). Follow the procedures accordingly. These methods are used to identify the material. Qualitative and quantitative analysis is performed to test the quality of the material or the product.
Method Validation is a key role of Quality Control. Our industry has developed some in-house methods of analysis to test the product. Such methods are needed to be validated. The method of chemical testing must be properly validated and documented as evidence.
Tests performed by the quality control department in the pharmaceutical industry
Physical as well as chemical parameters are performed to test any product. These parameters are the weight of a single dosage form, disintegration test, dissolution test, identification test, chemical assay, content uniformity test, and sterility tests.
Stability testing is a sensitive issue for the products. Products are stored under specific environmental conditions to check stability. Stability testing is also performed by quality control.
General instruments of quality control laboratory in pharmaceutical industry
• Weighing balance
• Disintegration apparatus• Dissolution apparatus
• Muffle furnace
• pH meter
• water bath
• friability tester
• hardness tester
Testing stages in quality control
In a quality control lab of our Pharmaceutical industry, testing is performed at three levels
• testing of Raw Material
• In-process testing
• Testing at Finished good stage
For the evaluation of the vendor of raw material, the advance samples are also tested by the quality control department. Apart from these, stability testing is also performed by quality control. Investigation of deviation and out of specification analysis is also performed by it under the lead of quality assurance.
The microbial laboratory is also part of the quality control department where sterility tests are performed. Not only this, but the quality control also coordinates with RND and the quality assurance for the achievement of the quality of the product.
Being a part of the quality system, Quality Assurance performs sampling at every stage and ensures the results of the quality control department.