GMP Manufacturing is conducted at our MHRA (MIA) IMP licensed facility, which can deliver bespoke clinical studies from single dose to batch production.

Production is facilitated by a range of specialised equipment and services, including a dedicated Aseptic Manufacturing Facility. Our suites can be used for the preparation of an extensive range of sterile products e.g., Intravenous Injections in the form of syringes or bags. We 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.

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 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.

This ensures the safe production, reconstitution, manufacture, manipulation, and dispensing of products in a controlled environment.

Other manufacturing activities include:

• Manufacture of non-sterile hard-shell capsules
• Manufacture of non-sterile other solid dosage forms
• Primary packaging of non-sterile other solid dosage forms
• Sterilisation of active substances/excipients/finished products – by Filtration
• Non-Sterile investigational medicinal products – liquids for internal use

Along with routine randomisation, blinding, product packing and labelling.

These all occur within separate, dedicated, manufacturing areas, to ensure safety, quality, efficiency, product segregation and line clearance.

Visit the MAC GMP Website.

MAC’s in-house pharmacy provides a medicine dispensing service and extends to patient dosing. Our team of pharmacists lead this service to ensure a safe and effective medicines system. We also manage our on-site pharmacies to ensure correct drug storage, reconciliation, accountability, and safe usage.

MAC Clinical Research ensures that clinical supplies and products are provided and distributed to wherever they are needed globally. MAC provides an effective logistical solution for importing and distributing a wide range of products, including controlled substances, at required temperatures.

MAC has a vastly experienced QP Release Team, who have worked in the industry for many years. The team ensure that each batch of product manufactured conforms to current legislations and all regulatory requirements. They have overall responsibility for product quality and are legally responsible for batch certification before products are used in clinical trials.

This is an extensive part of MAC’s pharmaceutical service. IMPs are managed by expertly trained staff who understand the importance of ensuring that quality, integrity and safety is maintained. MAC have a companywide 24/7/365 environmental monitoring system, which alerts the team of any temperature excursions. This system provides alerts before temperatures go out of specification, so that we can ensure corrective actions are taken. Our system also alerts via email and to a dedicated phone application to designated personnel, to ensure full and consistent system monitoring. MAC can store items from -80°C all the way up to room temperature, depending on the product’s requirements.

MAC Pharmaceutical Services provide controlled drug services across all our dedicated research sites. Sites are fully licenced, and equipped with appropriately controlled storage facilities. MAC is eligible to possess Schedule 1 to 5 controlled drugs, through our Home Office licences. The licences indicate our capability to hold, supply, produce and administer these products at each of our sites.