GMP Manufacturing
The skillbase at MAC is an essential factor in facilitating the vision, ethos and ultimately the business acumen of the company. Whilst providing regular pharmacy at each Dedicated Research Site, MAC also has aseptic suite facilities for GMP with an MHRA MIA (IMP) licence. Our suites can be used for preparation of an extensive range of sterile products e.g. Intravenous Injections and have Grade A negative pressure isolators, Microbiological Safety Laminar Flow Safety Cabinets (in Grade C monitoring), Good Manufacturing Practice (GMP) Grade B Clean Rooms which are EN ISO 14644-1 compliant.
Our temperature controlled suites and storage areas are serviced on a quarterly basis to stringent microbiological performance test standards (DOP testing, SDA and TSA settle and contact plates) and to ensure the room functionality conforms with the required specified limits of GMP Grade B specifications.
GMP Manufacturing capabilities across sites and aseptic facilities.
Naturally, our sites conduct all tests required to conform with industry standards. TSA settle and contact plates are monitored weekly and SDA settle and contact plates monitored monthly. MAC has invested heavily in resources over the past 5 years, to ensure that diverse capabilities are underpinned by the highest quality of service. Importantly, the teams of clean room staff at MAC are highly trained in aseptic techniques to ensure IMP is prepared precisely in accordance with SOPs, IMPDs, protocols and study specific pharmacy manuals.
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