Pharmaceutical & Medicinal Product Quality Control Testing

The failure to maintain the required temperatures during shipment of pharmaceuticals by road, air, rail or sea has the potential to result in entire shipments being rejected. MTD has wide experience of investigating such incidents and advising our clients whether the rejection of the shipment is justified or is one that is due to “fear of loss”.

We have similar experience of investigating problems that arise due to system failures during the long-term storage of pharmaceuticals in temperature controlled warehouses.

The system failures we investigate range from key equipment malfunctions through to breakdowns in adhering to approved standard operating procedures.

The breadth of issues we encounter during our pharmaceutical investigations requires the pharmaceutical team to be supported by experts in related fields. In addition to our chemistry and biotechnological expertise, we can draw upon our in-house expertise in metallurgy, materials and engineering to provide further expert opinion when required. All our experts are, in turn, supported by our extensive laboratory services, which are internationally recognised and accredited facilities.

Any pharmaceutical investigation has to recognise the highly regulated environment in which pharmaceutical companies and their third-party logistics providers operate. We have many years’ experience of dealing with both parties and this allows us to examine claims from both a regulatory and technical point of view.

We have spoken at an international conference on how the human element can cause adherence to the requirements of Good Manufacturing Practice and Good Distribution Practice to break down.