CGMP compliant facility

Shri J P Nadda, Union Minister for Health and Family Welfare recently inaugurated the first of its kind Current Good Manufacturing Practise (CGMP) compliant facility within the Central Government for manufacture of DPT and TT vaccine at the Central Research Institute (CRI), Kasauli in Himachal Pradesh. This makes CRI the first Central Government Institute to have cGMP compliant infrastructure for vaccine production.

• Recent advancements in regulatory requirements and introduction of cGMP concept in vaccine manufacturing had led to the need for creation of cGMP compliant infrastructure and processes.

 What are CGMPs?

CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).
CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.

• Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
• This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This also assures that drug products meet their quality standards.