(Current) Good Manufacturing Practice (c)GMP stands for guidelines for quality assurance in production processes and environments in the production of drugs and APIs. These guidelines do also apply in the production of cosmetics, food and feed products.
In the manufacturing of pharmaceutical products, quality assurance is an important part, since a direct impact on the health of consumers arises.
The relevant guidelines are created worldwide by various commissions (e.g. Federal Drug Administration (FDA), U.S.).
All necessary certificates and documents, which are required for later validation of the system, are created by VTA during planning, manufacturing, inspection, installation and commissioning of a GMP-plant.
VTA supports its customers in all phases of validation and qualification such as DQ (Design Qualification), IQ (Installation Qualification), FAT (Factory Acceptance Test, together with customer), SAT (Site Acceptance Test, together with customer), OQ (Operational Qualification) and PQ (Performance Qualification).
Target is the documented confirmation that the distillation unit fulfills the earlier defined requirements in the URS (User Requirement Specification)
In GMP-plants special focus is on material selection, surface qualities, drain design, cleaning (e.g. CIP, SIP) and complete documentation.
Delivery of GMP-plants has always been a day-to-day routine for VTA. On request, we can supply you with extracts of our GMP exemplar documentation.