Good Manufacturing Practices Standards

Recently, the government of India has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) for pharmaceutical companies which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.

About GMP

•Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards.

•It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

•It covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff.

•The GMP system was first incorporated in India in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and the last amendment was done in June 2005. WHO-GMP standards are now part of the revised Schedule M.

•There are around 10,500 manufacturing units in India out of which around 8,500 falls under Micro, Small and Medium Enterprises (MSME) category.

•The country has about 2,000 units in MSME category in the country having WHO-GMP certification.

What Are The New Regulations

•Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months,

•Medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year

What are the Major Changes In Revised GMP Guidelines

Pharmaceutical Quality System and Risk Management

The new guidelines introduce a pharmaceutical quality system, which emphasizes the establishment of a comprehensive quality management system throughout the manufacturing process.

Companies are now required to implement quality risk management practices to identify potential risks to the quality of their products and take appropriate preventive measures, also regular quality reviews of all products are mandated to ensure consistency in quality and processes.

Stability Studies

Companies are now required to conduct stability studies based on climate conditions. This involves maintaining drugs in stability chambers at specified temperatures and humidity levels to assess their stability over time. 

Additionally, accelerated stability tests may be conducted to assess the product's stability under accelerated conditions.

GMP-Related Computerized Systems

The new guidelines emphasize the use of computerized systems to manage GMP-related processes.

These systems are designed to prevent data tampering, unauthorized access, and omission of data. They also automatically record all steps and checks to ensure adherence to processes without any tampering.

Investigational Products For Clinical Trials

The new schedule M also lists out the requirements for additional types of products, including biological products, agents with radioactive ingredients, or plant-derived products.

The new guidelines lay out requirements for investigational products being manufactured for clinical trials. This ensures that the products used in clinical trials meet the necessary quality and safety standards.

What Is The Need For Revised GMP Guidelines

Alignment With Global Standards

Implementation of the new norms will bring the Indian industry on par with global standards.

Incidents of Contamination

There have been a string of incidents where other countries have reported alleged contamination in India-manufactured syrups, eye-drops, and eye ointments.

The deaths of 70 children in the Gambia, 18 children in Uzbekistan, three persons in the United States, and six deaths in Cameroon have been linked to these products.

Deficiencies In Current Practices

Risk-based inspection found numerous deficiencies in 162 manufacturing units in India.

Deficiencies include inadequate testing of raw materials, lack of product quality review, infrastructure issues, and missing qualified professionals.

There are only 2,000 of the 10,500 drug manufacturing units in India at present that meet global standards, being WHO-GMP certified.

The improved standards will ensure that pharmaceutical companies follow standard processes, quality control measures, and do not cut corners, improving the quality of medicines available in India as well as sold in the global market.

Confidence To Regulators From Other Countries

Instituting the same quality across the industry will give confidence to regulators from other countries.

In addition, it will improve the quality of drugs in the domestic markets. Most of the 8,500 manufacturing units that are not WHO-GMP certified supply medicine within India.

Way Forward

India's move to implement revised GMP guidelines signifies a significant step toward achieving global quality standards in the pharmaceutical industry.

The revised standards aim to enhance quality control measures, proper documentation, and IT support, thus ensuring the production of high-quality medicines in India and for the global market.