Good Manufacturing Practices standards

Good Manufacturing Practices standards

News: The government has set a deadline for pharmaceutical companies to implement the revised Good Manufacturing Practices (GMP) standards, aligned with World Health Organisation (WHO) standards.

What are GMP standards?
• Good manufacturing practices (GMPs) are guidelines or regulations that ensure that products, such as food, drugs, medical devices, and cosmetics, are produced and controlled according to quality standards.
• The World Health Organization (WHO) has defined GMP as the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.

What are the new regulations?
• Companies with over Rs 250 crore turnover must adopt the revised GMP within six months, while smaller enterprises having a turnover of less than 250 crore have a year.
• Non-compliance could lead to license suspension or penalties.
• The move seeks to enhance drug quality and safety, addressing deficiencies found in inspections The changes will include a pharmaceutical quality system, quality risk management, and product quality review.

What are the benefits of GMP?
• It reduces the likelihood of product contamination, labelling errors, and inconsistent ingredient levels.
• Reduce the risk of recalls, compliance issues, and other problems.
• Protect both Life Sciences companies and customers.
• Prevent and control contamination and cross-contamination.
• Prevent mislabeling and adulteration.