The government has implemented stringent regulations to ensure universal compliance with good manufacturing practices, aiming to enhance quality control across materials, machinery, personnel, and facilities within pharmaceutical companies. All pharmaceutical enterprises are mandated to adopt the revised good manufacturing practices and adhere to the stipulated regulations within a timeframe ranging from six to twelve months.
Smaller entities or Micro, Small, and Medium Enterprises (MSMEs) with an annual turnover below ₹250 crore must undergo compliance and certification processes within a twelve-month period, while larger companies, those with a turnover exceeding ₹250 crore, are required to implement these measures within the next six months. These regulations, recently notified, establish good manufacturing practices and adherence to the Revised Schedule M as compulsory for all pharmaceutical companies.
Out of the 10,500 manufacturing units in India, approximately 8,500 fall under the MSME category. Among them, around 2,000 MSMEs, primarily those engaged in export activities, currently possess a World Health Organization Good Manufacturing Practice (WHO GMP) certificate.
As reported by businessline, the enforcement of these rules brings significant changes, introducing elements such as a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), equipment qualification and validation, change control management, self-inspection, and the establishment of quality audit teams for both internal and supplier assessments. These comprehensive measures are designed to elevate and standardize manufacturing practices across the pharmaceutical industry, promoting enhanced quality and safety standards.
