– GMP Complying Warehouse/ Production Facilities
WHAT IS A GMP CLEANROOM?
A GMP cleanroom is one that complies with Good Manufacturing Practice (GMP) standards is a quality management system used predominantly by medical and pharmaceutical manufacturers to ensure a controlled cleanroom environment for operations.
The main goal of GMP standard is to minimize the risks of microbiological, particulate, and pyrogen contamination during the preparation and sterilization of medicines or medical devices. Any application that involves producing, filling, compounding, or packaging sterile medicinal products must comply with GMP standards to ensure a high level of product safety and consistency. To achieve this level of control, safety, and repeatability, GMP standards address a wide range of cleanroom issues, including:
- Equipment verification
- Personnel qualification
- Process validation
- Sanitation and cleanliness
- Record keeping and documentation
MAC are able to help client to design and build GMP (adhere to PCI/S Guide to GMP – 21CFR) compliance warehouse / production or re-packaging facilities.
We work with GMP consultants to provide consultancy services to our clients and ensure their facilities are formally accredited GMP facilities.
GMP Environment Requirements :-
1). To prevent cross-contamination through cleanliness
2). Maintain systems, facilities and equipment
3). Prioritize quality and integrate into the workflow
Do contact us for detail discussions and prevent rightful design for your facilities.