When we purchase any medical, Ayurveda, food or nutraceutical product, we may see in the label that the product has been manufactured under GMP compliance. So this article is to describe what does GMP mean and how it impact on our health.
What is cGMP
cGMP stands for Current Good Manufacturing Practices, is a set of regulations enforced by a regulatory body requiring Raw materials are procured from approved vendor then tested and released before use in batch, area are suitable for manufacturing, area is properly cleaned and arranged, equipment are suitable for use, qualified and calibrated on periodic basis, personnel are properly trained and qualified, activities are documented, are few examples how cGMP works. If these can be put in to practices in a pharmaceutical manufacturing plant, mix-ups, contamination, product failure can be avoided. ‘C’ in cGMP stands for current which allows company to use technology which are modern and up to date.
Many company uses risk management approaches to meet the requirements of quality products to ensure their intended purpose and to protect the public health. GMP ensures that quality is built into the organization and processes involved in the manufacture of the products and all those operations should be carried out strictly according to cGMP (Current Good Manufacturing Practices). A comprehensive quality system model, which, if implemented, will allow manufacturers to support and sustain robust, modern quality systems that are consistent with cGMP regulations. The inherent flexibility of the cGMP regulations should enable manufacturers to implement a quality system in a form that is appropriate for their specific operations. This guideline applies mainly to manufacturers of medicinal products (finished pharmaceuticals). However, the principles can be extended to the manufactures of food, medical devices, herbal medicines, cosmetics, etc. In future, the Authority will establish, where appropriate, specific cGMP requirements as supplements to the main guide to address matters related to certain product quality requirements. The guideline serves as a basic minimum requirement for both local pharmaceutical companies and foreign companies to be authorized for import products. It is also a reference and guidance tool to the Authority for GMP inspection and licensing of establishments. The requirement for establishment licensing is described in the guideline for establishment licensing. The guideline is a minimum requirement and as such does not restrict any new technological development and concept, which have been validated and installed in the manufacturing of products to improve the quality assurance system. The guideline shall be regularly reviewed and revised considering the needs and technological growth in the pharmaceutical sector.
A user cannot detect product quality through smell, touch, or sight hence does not know whether the product will work and safe for use. Testing alone cannot guarantee the quality of the product as what is tested is destroyed and what is consumed is not tested. So quality should be built in to every step of the manufacturing of the product.
For example a company produces 10 Lakh injection vials in a batch. Out of 10 Lakh vial one is found with defected quality and defected vial is used for treatment of our nearest one. So that person died. For the manufacturing company success rate may much higher but for me its a 100 percent loss. Hence that much care shall be taken during manufacturing of the drug product. Same way as a consumer we should be careful while purchasing any product which will be used for human or veterinary consumption.
Every label claim is not truth
A lot of company may claim that the product is manufactured under cGMP compliance but actually they may compromise with the requirements. For this reason only USFDA is giving warning letter or import ban to event many of top branded pharma companies. So, do study about the company profile before being a loyal customer of the company.