Vinod Arora, Principal Advisor Institute of Good Manufacturing Practices India–IGMPI, gives insights on ways to enable cGMP to assure safety and efficacy of drug products
Good Manufacturing Practices (GMP) is a part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by marketing authorisation. GMP represents minimum standards that are necessary. Many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum standards.
The first version of GMP guidelines for manufacturing, processing, packing or holding finished pharmaceuticals was introduced by the US FDA in 1963. Four years later, the WHO version of GMP was prepared by a group of consultants at the request of the 20th World Health Assembly. From then there were several amendments and extensions of the guidelines and many countries developed their own GMP guidelines which are based on WHO guidelines
- WHO GMP Guidelines – Primarily used by pharma regulators in developing countries
- International Community of Harmonisation – GMP
- USFDA –GMP
- GMP Standards in other countries – Australia, Canada, Japan , Singapore
- International Organization for Standards (ISO)
- Pharmaceutical Inspection Cooperation Scheme (PIC/s)
- Common practices within the industry license reviews, crisis management, controls also sources of GMP
In 1991, GMP standards were harmonised at EU level (MHRA 2007). In 1999, the ICH, a common project of the EU, Japan and the US brought GMP for Active Pharmaceutical Ingredients which apply in signatory countries, the EU, Japan and the US and also in other countries –Australia, Canada, Singapore. GMP standards is a dynamic process and are upgraded periodically.
The enforcement of GMP rests on individual states; For the US, the responsibility is with the USFDA, in the EU with National Regulatory Agencies (e.g MHRA in the UK), in Australia with Therapeutical Goods Administration, in India with Central Drugs Standards Control Organization, Ministry of Health and Family Welfare
The main regulatory standard for ensuring pharma quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharma. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective.
What are cGMPs?
cGMP refers to the Current Good Manufacturing Practice regulations. cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures 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 pharma company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards.
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically sound design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the ‘C’ in cGMP stands for ‘current,’ requiring companies to use technologies and systems that are up-to-date in order to comply with the
regulations. Systems and equipment that may have been ‘top-of-the-line’ to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today’s standards.
Why are cGMPs so important?
A consumer usually cannot detect (through smell, touch, or sight) that a drug product is safe or if it will work. While cGMPs require testing, testing alone is not adequate to ensure quality. In most instances, testing is done on a small sample of a batch (for example, a