What do you mean by gmp

This protects the consumer from purchasing a product which is not effective or even dangerous. Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure, fines, and jail time. GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, and complaint handling.

Governments save money on enforcement and regulation measures that might otherwise snowball out of control without GMP to guide everyone. Being a responsible manufacturer means abiding by good manufacturing practices. So, everything to do with your physical premises from the equipment it contains to its very layout must be factored against good manufacturing practices.

Well-defined processes can help a manufacturer stick to the legislative requirements surrounding GMP and produce quality, safe products every time. Good manufacturing practice depends on well-documented processes. If your policies provide the guidelines and rules to follow in the business and your documented processes outline the journey of your products from end to end, then it is your procedures that are the step-by-step instructions of how to achieve those processes.

In order to remain compliant with GMP legislation then your procedures must be detailed down to the nitty-gritties as well. From then on, you will be inspected on a regular basis.

If the MHRA deems your organisation to be at a higher risk based on their risk ratings system , you may be inspected more frequently as a priority. However, each nation typically has its own inspectors run by the local regulatory authority.

Each country in the EU has its own regulatory body and so manufacturers must apply to the applicable authority for their country.

In order to be certified to manufacture pharmaceutical and related products in the US, you will have to apply for approval with the FDA. At that point FDA assessors will arrive to determine if your company has the necessary equipment and ability the five Ps to safely manufacture what you intend to make.

Medical devices are also licensed separately to other therapeutic goods such as medicines, with manufacturers of these products requiring a Conformity Assessment Certificate. Medsafe refers to the above-mentioned code whenever a manufacturer applies for a License to Pack Medicines or Licence to Manufacture Medicines, or for a GMP certificate. An auditor may come to your premises to check for compliance, although this may not be necessary if you can produce equivalent compliance documents from a recognised overseas agency.

Good manufacturing practices exist to protect customers and manufacturers alike from the risk of faulty products. They combine a mixture of best practices — known as the five Ps of GMP — as well as strict legislation to ensure compliance and mitigate the risk that a harmful product may end up in the market.

Australia Department of Health — Good manufacturing practice overview. The wholesale distribution of medicinal products is an important activity in integrated supply chain management. Today's distribution network for medicinal products is increasingly complex and involves many players. These guidelines lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent counterfeit medicine from entering the legal supply chain.

Compliance with these guidelines will ensure control of the distribution chain and consequently maintain the quality and the integrity of medicinal products.

In our GMP Glossary you will find over official definitions of many important terms used in everyday pharmaceutical practice. We list terms of the following sources:. A helpful and easy to read guide which facilitates the entry into the complex world of Good Manufacturing Practice GMP and teaches the necessary basics.

What is GMP? Anyone who takes part in the production of medicinal products or active pharmaceutical ingredients must comply with GMP regulations, regardless of whether that individual is employed in Executive Management Quality Management Production Quality Control or Engineering of a pharmaceutical company or supplier.