GMP Complying Warehouse/ Production Facilities
WHAT IS A GMP CLEANROOM?
A GMP cleanroom is one that complies with Good Manufacturing Practice (GMP) standards. It 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
- Workflow
- 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
- To prevent cross-contamination through cleanliness
- Maintain systems, facilities and equipment
- Prioritize quality and integrate into the workflow
Do contact us for detailed discussions and prevent rightful design for your facilities.
Major International Codes of GMP | |||
| Product Category | International/Asia | USA | Europe |
| Active Pharmaceutical Ingredients | ICH Q7A | ICH Q7A (Guideline only | ICH Q7A |
| Non-sterile Products | PICS Guide to GMP for Medicinal Products | 21 CFR 210, 211 | PICS Guide to GMP for Medicinal Products and EMEA Guidelines |
| Sterile Products | PICS Guide to GMP for Medicinal Products Annex 1 | 21 CFR 210, 211 | PICS Guide to GMP for Medicinal Products Annex 1 and EMEA Guidelines. |
| Biologics | PICS Guide to GMP for Medicinal Products Annex 2 | 21 CFR 600-680 | PICS Guide to GMP for Medicinal Products Annex 2 and EMEA Guidelines |
| Cellular Therapies, Blood & Tissues | PICS Guide to GMP for Medicinal Products Annex 14 | 21 CFR 16, 1270, 1271,600-680 | PICS Guide to GMP for Medicinal Products Annex 14 and EMEA Guidelines |
| Investigational Products | PICS Guide to GMP for Medicinal 21 CFR 312, 314 Products Annex 13 | 21 CFR 312, 314 | PICS Guide to GMP for Medicinal Products Annex 13 and EMEA Guidelines |
| Medical Devices | EN 46001/2, ISO 13485, ISO 9001 | 21 CFR 820 | EN 46001/2, ISO 13485, ISO 9001 |
