Good manufacturing practices are required in order to conform to the guidelines recommended by agencies that control the authorization of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
GMP
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GMP CERTIFICATION!
HIGHLIGITS
OVERVIEW
Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.
Our specialized GMP audits, which include thorough on-site assessment and detailed reports with objective data, help you achieve GMP compliance and secure food safety in your supply chain. GMP audit include a review of:
- Raw materials (including water)
- Production processes
- Equipment used in processing and manufacturing
- Labeling process
- Personnel training and handling practices
- Buildings and facilities
- Prevention of physical and chemical hazards
- In-house laboratories
- Records and documentation
- Consumer complaints recording
REGISTRATION PROCESS
1. Preparation
Preparation of plant and documents as per guidelines
2. Test Lab
Setting up of in house test lab
3. Product Testing
Testing of product from approved lab
4. Application
Submission of Application
5. Inspection
Inspection
6. License
Issue of License
ARE YOU READY FOR GMP CERTIFICATION !
FREQUENTLY ASKED QUESTIONS
1. Why is GMP important?
Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers.
2. Poor quality medicines can damage health
A poor quality medicine may contain toxic substances that have been unintentionally added.
A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect.
3. GMP helps boost pharmaceutical export opportunities
Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. Governments seeking to promote their countries’ export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements.
4. Is GMP necessary if there is a quality control laboratory?
Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the product afterwards. GMP prevents errors that cannot be eliminated through quality control of the finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same quality as the units of medicine tested in the laboratory.