Good Manufacturing Practice
Rules and guidelines for ensuring quality in the production of pharmaceutical products, active ingredients, foodstuffs, animal feed and cosmetics.
Manufacturers of medicines, active substances, food and all other areas, the use of which directly affects the health of consumers, must at all times ensure that their processes and products do not have a negative impact on the lives of consumers. In addition to production, this also includes management, control, the necessary measures and documentation vis-a-vis the authorities. Only when everything is ensured and fulfilled may a manufacturing permit be issued.
Since there is no internationally uniform GMP guideline, the production facilities are designed in accordance with the respective laws and regulations of the industry in the country of manufacture and / or in the corresponding export country. It should be noted that proof of compliance must be submitted before the placement of products on the market and the use of medicines, active substances, cosmetics, food or feed. This task is assigned to the manufacturing company by specifications and checked by the authorities.
At SCHRADER, both the development and the production of the systems are managed from a single source. With many years of experience in plant construction and specially trained employees in the disciplines of GMP and plant qualification, SCHRADER offers individual solutions for projects in the field of pharmacy, food and cosmetics.
SCHRADER develops tailor-made solutions for every requirement and every application form of a product. For example, the service programme includes e.g.:
The scope of delivery includes basic and detailed engineering, construction and, if required, 3D planning to comply with the applicable hygienic design and aseptic design standards, factory acceptance test (FAT) with spray masking test in accordance with the VDMA data sheet, as well as assembly, commissioning and acceptance at the installation site (Site Acceptance Test, SAT). In addition, support in the planning and implementation of plant qualification, as well as regular maintenance, is, of course, possible. The scope of the necessary GMP measures is determined by the GMP risk analysis and contractually recorded.
Good Manufacturing Practice (GMP) includes, depending on the product and use:
National laws and
EU GMP Directive
GAMP, I Set of Rules
Operating specifications, work instructions
In Germany, according to section 13 of the German Medicines Act (AMG), the holder of a manufacturing permit must have suitable facilities for the production, testing and storage of the medicines (section 14 para. 1 No. 6 AMG). Therefore, the Medicines and Active Substances Ordinance (AMWHV) stipulates that plants that are used for the production of medicines and that are of decisive importance for quality must be qualified (section 5 para. 2 of the Regulation on the Application of Good Manufacturing Practice in the Manufacture of Medicinal Products and Active Substances, and on the Application of Good Professional Practice in the Manufacture of Products of Human Origin – AMWHV).
For this purpose, the following note on “Qualification of Equipment” can be found in the EU GMP Guide (in Chapter 3.34): “Manufacturing equipment should be designed, arranged and maintained in such a way that it is suitable for its intended purpose.” The implementation of this requirement is regulated in Annex 15 to the EU GMP Guide.
The same applies to the USA. Here, under the “Federal Food, Drug and Cosmetic Act (1939/1997)” (FD&C Act), are the formulations of the general and permanent regulations of the USA, the so-called “Code of Federal Regulations” (CFR), which also includes the “Title 21 Foods and Drugs”, which is important in the GMP environment.
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