“Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.“
(EC Directive 2003/94/EC, Article 8.1).
“… buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations. Any such building shall have adequate space for the orderly placement of equipment and materials to prevent mix-ups … and to prevent contamination.”
(21 CFR Sec. 211.42 (a) (b)).
Premises and equipment are the basic technical components of pharmaceutical production. From the GMP standpoint they have a great significance, being in contact with pharmaceutical products from the raw material stage through to the finished product.
In our ebook "Premises" you will find answers to these and more questions:Which official requirements must be observed when designing rooms in accordance
with the EU GMP Guide and the U.S. cGMP regulations?
Which design concepts does FDA recommend for an aseptic processing facility?
How can the requirements for the different room grades be met?
What details must be observed when designing rooms for pharmaceutical purposes?
What has to be taken into account during installation of building services in clean rooms?
Which physical and microbiological parameters require monitoring?
Table of contents- Official Requirements
- Material flow, personnel flow and layout
- Room classes
- Construction elements
- Barrier systems and isolators
- Building services
- Heating Ventilation Air Conditioning (HVAC)
- Process Gases
- Qualification of premises and airconditioning systems
- Monitoring of HVAC systems
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