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Good Manufacturing Practices (GMP) by WHO

Ensuring Pharmaceutical Safety: Importance of Good Manufacturing Practices (GMP)

Description: Discover the significance of Good Manufacturing Practices (GMP) in maintaining quality and safety standards in pharmaceutical production. Learn about the implementation of GMP based on WHO standards for enhanced drug safety.

Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organisation (WHO) standards.

Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year

What are Good Manufacturing Practices?

Good Manufacturing Practices (GMP, also referred to as 'cGMP' or 'current Good Manufacturing Practice') is 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.

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.

The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

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

Detailed, written procedures are essential for each process that could affect the quality of the finished product.

 There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made

Why is CGMP so important?

A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While CGMP requires testing, testing alone is not adequate to ensure quality. In most instances testing is done on a small sample of  batch (for example, a drug manufacturer may test 100 tablets from a batch that contains 2 million tablets), so that most of the batch can be used for patients rather than destroyed by testing. Therefore, it is important that drugs are manufactured under conditions and practices required by the CGMP regulations to assure that quality is built into the design and manufacturing process at every step. Facilities that are in good condition, equipment that is properly maintained and calibrated, employees who are qualified and fully trained, and processes that are reliable and reproducible, are a few examples of how CGMP requirements help to assure the safety and efficacy of drug products.

Principles of GMP

1.      Create Standard Operating Procedures (SOPs) 

2.      Enforce / Implement SOPs and work instructions

3.      Document procedures and processes

4.      Validate the effectiveness of SOPs

5.      Design and use working systems

6.      Maintain systems, facilities, and equipment

7.      Develop job competence of workers

8.      Prevent contamination through cleanliness

9.      Prioritize quality and integrate into workflow

10.  Conduct GMP audits regularly