GMPs or Good Manufacturing Practices are the practices and the systems required to be adapted by Pharma industries in drug manufacturing, food processing and handling, quality control, also the quality system involving the manufacture and testing of pharmaceuticals including active pharmaceutical ingredients, foods, pharmaceutical products, medical diagnostics and medical devices. GMP is a global conceptual approach designed to minimize the potential risks to the patients involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP constitutes the mandated license to operate in pharmaceutical manufacturing all over the world.
The term ‘GMP’ is well identified worldwide for the quality control and management of manufacturing and quality testing of pharmaceutical products. There is also another term into existence called cGMP (Current Good Manufacturing Practices). cGMP with its nomenclature reminds most of the companies to comply with updated regulations.
Above all, pharmaceutical manufacturers must not place patients at risk due to inadequate safety, quality or efficacy that outline the aspects of production and testing that can impact the quality of a product.
Why is GMP Important?
Pharmaceutical quality is of vital importance for safety of life. Hence, several regulations are made mandatory, one such key is GMP.
For instance, just imagine getting a prescribed drug from the pharmacy and hoping the best for the drug to work and get well soon. You may have no idea on the quality of efficacy of the drug, but GMP regulations includes all those what patient needs for using the drugs including below:
- Label on the Drug
- Safe for human consumption
- Drug Efficacy
- Use by or Expiry Date
- Correct Dosage
- Quality Tested
- Contaminated with microbes (if any such)
In Today’s World, GMP is established to regulate the standard quality of pharmaceuticals and other medical products. GMP lies at the heart of Pharma Industries. GMP has gained much importance as they are guidelines which are especially enacted to ensure quality and safety in the production of food, drugs, cosmetics, medical diagnostics and devices. These GMP regulations, enforced by the Food and Drug Administration, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.
But, why do we actually need the GMPs? Shouldn’t we (individuals, companies) simply and strictly follow Quality control regulations and be able to figure out any errors during production of pharmaceutical drugs medical devices thereby yielding safe and effective products. Yes, Of course, Good quality must be implemented during the manufacturing process, but it cannot be testing tool for the final product. GMP checks all the errors that cannot be however eliminated through quality control of the finished product. GMPs are claimed to be standard legal regulations which protects the consumer from purchasing a product which is not effective or even dangerous. Failure of pharmaceutical firms to comply with GMP regulations can result in very serious risky outcomes.
This blog highlights the importance of GMP in Pharma industry, bringing out the best information to the students aspiring to begin their career in Pharma.
Merits of GMP
GMP exists mainly to protect the health and safety of patients or consumers. Do you wonder what would be the benefits of GMP?
GMP takes the credits of following benefits.
- Evidence of safe and efficient product.
- Compliance with legal requirements.
- Increases consumer confidence and trust buildup in your products.
- Reduction of product claims, returns, reprocesses and rejections.
- GMP helps boost export opportunities.
- Cost saving benefit.
Demerits without GMP:
- Unexpected product contamination
- Causing damage to health or even death
- Labeling Errors
- Ingredients Composition
Who Need GMP?
GMP is required by the Pharmaceuticals industries, Biotech companies, Bulk drug API manufactures, Formulators and Food Processors, Manufacturers of Medical devices, cosmetics and other life-science industries.
GMP is incorporated by more than 100 countries into their medicine’s laws, and also many more other countries have adopted their own GMP requirements. However, WHO-GMP stands as a basis for the WHO Certification Scheme and prequalification of vaccines.
In general, Pharmaceutical firms and biotechnology companies follow GMPs to ensure their products are manufactured adhering to specific requirements like identity, strength, quality, purity, efficacy and safety. Compliance is regulated by the Food and Drug Administration (FDA).
Topics included in GMP and following regulations in below areas of Pharma industry.
- Area or Location: Buildings and Facilities.
- Equipment: Maintenance of equipment, cleaning, calibration and validation.
- GMP Validation.
- Production and In-process controls.
- Production Materials: Proper management.
- Packaging and Labeling of Products.
- Laboratory Controls.
- Personnel: Qualification, Safety and Responsibilities.
- Complaints and Recalls.
- Change Control.
- Computer Systems and Information Technology.
- Quality Assurance and Quality Control.
- Documentation and record keeping of GMP procedures.
- Drug Product Regulations.
Low standard quality medicines are not only a health hazard, but a waste of money for both governments and also individual consumers, it may also lead to shortage of drugs. GMP regulates all such quality issues of medical products and hence GMP is currently very crucial. The majority of countries accept the import and sale of medicines that have been manufactured to internationally recognized GMP standards.
Individuals looking for a new challenge in the pharmaceutical quality field, with keen interest entering demand career path, simply go through the training programs available through Pharma Knowledge Centre. Here in the training offered, you can learn everything about good manufacturing practices which you’ll definitely need to make a smooth transition into your career path. PKC is offering a best opportunity in the Pharma industry to get certified for becoming a GMP Professional.
Pharma Knowledge Centre is designed to help Pharma graduates to understand the basics on Good Manufacturing Practice with the Practice course for students including Hand’s on training. Contact the PKC team to get started today to become an expert in Good Manufacturing Practice. The knowledge provided by PKC is intended to guide students entering into Pharma industries.
Topics covered in syllabus of PKC GMP Training include: Brief about Pharma Companies, GMP History and GMP Requirements, Work flow, Production Management, etc.
The GMP training program of PKC has been designed in a way so as to compliment the basic education and judge the job opportunities in providing a platform for Life Science and Pharmaceutical professionals to enter Pharma and biotech industry. In this GMP program, there is a great scope to learn and acquire specialized knowledge and most importantly practical skills required to function personnel in various arenas like pharmaceutical, biotechnology, medical device, food, cosmetics, and also other associated life-science industries.
- Chaloner-Larsson, Gillian, Anderson, Roger, Egan, Anik, Da Fonseca Costa Filho, Manoel Antonio, Gomez Herrera, Jorge F. et al. (1999). A WHO guide to good manufacturing practice (GMP) requirements.
Pharma Knowledge Centre – “My Learning Life” (PKC) engaged Young Indian Youths to prepare this presentation/Blog and the same has been prepared by one of the associated youngsters in consultation with PKC.
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