The selection of raw materials and their suppliers is a key issue at every stage of a drug’s life cycle (from R&D through to marketing).
As qualification requirements for suppliers and raw materials are either non-existent or very low in the early stages of a drug’s manufacturing process development, quality departments are often not involved, or are only minimally involved, in the selection process for raw materials and their suppliers during these phases. It is not uncommon for low-quality raw materials to be used during these development phases (R&D grade materials, for example). These materials may have poorly defined specifications, or none at all. It is also possible that the manufacturers of these materials produce them using an uncontrolled manufacturing process and without a quality system, or with a low-level quality system.
Failure to take quality aspects into account when selecting raw materials during the development phase can lead to numerous complications when the product enters the clinical phase:
- Inability to qualify the supplier, or complicated qualification, with the need for frequent audits and an extensive remediation plan with the supplier.
- Inability to qualify material to GMP requirements. The supplier may be unable to provide the quality documentation needed to qualify the material. Lack of control over the manufacturing process for these materials can lead to high inter-batch variability, resulting in numerous batches that do not meet the drug manufacturer’s specifications.
As a result, the drug manufacturer ends up with very high-risk materials and suppliers, which will cause many problems if he continues to use them. It may therefore be necessary to change supplier in order to have a raw material and supplier of adequate quality. A change of material/supplier can be complex to manage, with a potential impact on the manufacturing process and the need to adapt it. This can greatly delay the drug’s progress towards commercialization, and have a significant financial cost.
For all these reasons, it is important to take a long-term view and to consider quality aspects in the selection of materials and their suppliers as early as possible in the development of a drug. It is important to have a multi-disciplinary approach, and for the scientists in charge of drug development to work with quality personnel in the choice of raw materials and their suppliers. In the case of R&D grade materials, it is essential that the supplier also has the same material in pharmaceutical grade and produced using a similar manufacturing process, so as to be able to make the switch when the developed drug goes into GMP production.
