Good manufacturing practice is marked by an interesting history and has transformed over time. This post seeks to explore all that GMP entails – its history, definition, basic tenets, variations and importance.
A Brief History on GMP
The industrial revolution transformed agriculture in the 19th century. The improved productivity in farm produce could now be transported all over the country in an unprecedented way. However, these blessings came with its drawbacks.
Toxic chemicals were used as preservatives, unpasteurized milk was rampant, medicines contained uncontrolled amounts of narcotics. All these raised the dangers of consuming food and medicine. Consequently, the dawn of the 20th century was marked by the apparent need to enact regulations to prevent the society from the potential threat posed by these products.
What is GMP?
Good Manufacturing Practice (GMP) is a set of guidelines that ensure the quality of food, pharmaceutical devices, drugs and blood sample. For more insight into what GMP is, kindly view our post on What is GMP?
Basic Tenets of GMP
GMP are marked by subtle differences among countries. Similarly, GMP varies among various industries. However, they are hinged on the same basic tenet – to protect the health interest of the end users of a product. To achieve this, GMP covers various aspect of production. It ensures that the production personnel are adequately trained and it also ensures that the end-products are rigorously tested to ensure contaminant-free products. Some of the basic principles of GMP includes:
Good Hygiene and High Quality
The manufacturing facility should be clean at all times. Similarly, the production process must be carried out in the appropriate environmental conditions in other to prevent adulteration and to ensure that the products meet the specifications.
Documentation covers a lot of the manufacturing aspects. Procedures for carrying out operations must be unambiguously stated. Also, the production history must be well documented at all times. This will enable manufacturing companies to note marked deviations and it will also enable them to trace a product’s batch if it is identified to be unsafe for consumption. To get more understanding of GMP Documentation, you should read our post on GMP Documentation and Records.
The distribution of products should in no way reduce its quality. Travel distance, transportation conditions and expiry date must be taken into account to ensure that products are adequately distributed to the end users.
Variations of GMP
Different countries have their prevalent GMPs. In the United States, the Food and Drug Administration (FDA) is responsible for creating the GMP guidelines. In over a hundred countries, the GMP created by the World Health Organization (WHO) is prevalent. Several countries like Japan, Canada, Singapore, Vietnam and the European Union uses a GMP that is a slight variation of WHO GMP.
How are good Manufacturing Practices Enforced?
Several countries have a specified regulatory agency that is responsible for ensuring that companies comply with the stated GMP.
Some popular regulatory agencies include:
- US Food and Drug Administration enforces GMP in the United States;
- Therapeutic Goods Administration (TGA) in Australia,
- National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria;
- Medicines Control Council (MCC) in South Africa;
- Ministry of Food and Drug Safety (MFDS) in South Korea;
- Drug Regulatory Authority in Pakistan;
- Directorate General of Drug Administration (DGDA) in Bangladesh; and so on.
These agencies carry out routine checks in manufacturing sites. Also, they carry out unannounced inspections from time to time to ensure that the companies are always in compliance with good manufacturing practices.
The Importance of GMP
Good manufacturing practices are important because they ensure that the quality of food and drug meet-up to the minimum safety standard. Without GMP, companies would be at liberty to manufacture products any way they like, regardless of safety considerations.
GMP has, indeed, have a profound effect on raising the quality of products. With current advances in technology, manufacturing costs have declined while speed and quality have increased. These factors will enable companies to adhere to GMP without compromising lots of profits.
Similarly, technology makes it easier for regulatory bodies to enact GMPs. At the moment, there are over 20 GMPs. In the future, there would probably be an international harmonization of these GMPs to form a regulatory framework. It is almost certain that the future is brighter as industries will be held to higher manufacturing standards. Consequently, the quality of human health is expected to further improve.