What is the difference between GMP and GLP?
Both Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations are vitally related to laboratory testing. However, the two categories of regulation have notable differences, beginning with their end goal.
Good Manufacturing Practice
GMP is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production and testing that can impact the quality of a product. Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
A Good Manufacturing Practices (GMP) Certificate can be issued by companies, which are able to document adherence to Good Manufacturing Practices, as outlined by the U.S. FDA, State Health Departments, or by another set of standards. Most countries prefer that GMP certificates be issued from a trade association, such as ACMA.
What are Good Manufacturing Practices (GMP)?
Good Manufacturing Practice (GMP)
- Establish Good Written Procedures.
- Qualify and Validate Processes.
- Identify Roles and Responsibilities.
- Keep All Records.
- Use the Right Facilities and Equipment.
- Assemble a Competent Team.
- Practice Good Hygiene.
- Maintain Facilities and Equipment.
- Ensure Quality.
- Use GMP Audit Checklists.
What is GMP contract manufacturing?
A GMP technical agreement ensures compliance to the current good manufacturing practices (cGMP). Need for a Technical Agreement. By defining a clear technical agreement, both parties know who will be responsible for what, thus avoiding conflicts and have defined a clear escalation route.
Is GMP the same as cGMP?
GMP is widely being used in the world when compared to CGMP. In fact, more than 100 different countries out there in the world tend to use GMP. However, only handful countries adhere to the guidelines of CGMP. GMP is widely applicable to a large number of situations out there in the world, when compared to CGMP.
What countries use GMP?
The World Health Organization version of GMP is used in over 100 other countries, mostly in the developing world. Similar GMPs are found in the EU, Australia, Canada, Japan, Singapore, and the Philippines. HACCP is used in the US, and is enforced by the FDA (for seafood and juice) and USDA (for meat).
What is a GMP lab?
GMP laboratories are laboratories that follow and systematically document adherence to Good Manufacturing Practice regulations, recognizing the importance of putting quality first and upholding production excellence at every step of the pharmaceutical manufacturing process.