Good manufacturing practices (GMP)
- Training / workshop
- Risk analysis
- Gap analysis
- System validation
- Software validation
- Hardware qualification
- Validation documentation
- Change control
Complex matter presented in a comprehensible way
With Good Manufacturing Practices (GMP), your organization complies with the guidelines prescribed by agencies that issue and control the authorization and licensing of the production and sale of food, beverages, cosmetics, pharmaceuticals, dietary supplements, and medical devices.
These guidelines set out the minimum requirements that a manufacturer must meet to ensure that its products are consistently of high quality from batch to batch for their intended use. The ISO 13485 standard is designed to minimize the risks that cannot be eliminated by testing the final product.
The main risks are unexpected contamination of products that cause damage to health or even death, incorrect labelling that can lead to patients receiving the wrong medicine and, finally, insufficient or too much active substance in the product, causing ineffective treatment and adverse effects. The rules can vary considerably from industry to industry but the main purpose of GMP is always to prevent damage to the end user.
GMP includes additional principles to ensure that the product is free of contamination, that it is consistent in its production, that its manufacture is well documented, that the staff is well trained and that the product has been quality checked for more than just in the final stage.
From on-site expertise to the complete package
Bring out the Best is happy to organize an on-site workshop for your staff. Your employees actively participate and thus learn the basic principles of GMP. In addition, their quality awareness is increased. This workshop can also be tailor-made for your organization.
Bring out the Best is also happy to support you with the other issues you may encounter with GMP (and the ISO standards 9001, 27001 and 13485). Certification is an intensive process that, in addition to quality assurance, also includes themes such as cleaning, SOPs, distribution and recall.