With good reason, the manufacturing and distribution of pharmaceuticals is a highly regulated process. A robust management system must be in place to ensure compliance with the World Health Organisation (WHO) Good Manufacturing Practice guidelines as well as all local regulations, and to ensure satisfactory delivery of products.
Forensic Investigations
Failure of machinery in both the manufacturing and distribution process can result in a costly loss, as all manufacturing machinery must meet standards of sterility and all transportation must be highly controlled.
Our experts have been instructed on many losses associated with pharmaceutical products, including:
- Root cause investigation of a fire which resulted from a build-up of static electricity due to the use of cleaning products that are used to maintain a suitably sterile environment that complies with regulation.
- Smoke contamination of raw materials used in the active product. We were able to determine the level of contamination in a raw material and whether it was suitable for production through the use of sample testing.
- The failure of a chiller used to maintain an appropriate temperature for pharmaceuticals. As a result of the failure of the chiller and the failure in the temperature notification system, the finished product spoiled, costing the manufacturer over a million dollars.
Risk Management
To manage the risks associated with the pharmaceutical industry and to remain in compliance with all global regulations, a robust risk maintenance system is necessary. We have provided risk assessments for pharmaceutical manufacturing plants, paying particular attention to the technical and operational controls in place that are used to ensure compliance with applicable regulations.
We interrogate Building Management Systems (BMS) and analyse operational conditions such as temperatures, humidity, air quality and water purification systems to ensure equipment and processes meet the strict conditions required by GMP guidelines and other local regulations.
We have worked with several facilities in the supply chain for pharmaceuticals, including manufacturers, laboratories, suppliers of raw material (active ingredients and non-active ingredients), warehouses and logistics operators that handle the transportation and storage, hospitals and other medical establishments that must comply with appropriate industry standards.
