Many companies are paying high cost API sources and would like to change source. Drivers of change may include quality or performance improvements, better assurance of GMP and regulatory compliance, increase reliability of supply or to reduce costs, lead time and/or working capital.
Switching API source involves a considerable amount of work including checking that the new supplier really can supply and is GMP compliant, checking that the new API source does actually work in the product, generating stability data on the new source, and demonstrating BE.
Competitive bidding has historically been used to reduce the cost of purchased materials. In the case of APIs, it is not always clear that lower ingredient prices will generate a satisfactory return on the effort to qualify an additional source of supply.
However, there are several potential challenges to changing API sources. Whenever making a change from one source to another, pharmaceutical regulations require a stringent process be undertaken to qualify the new source. This process must be repeated in part for each product form or SKU utilizing that ingredient. This effort may involve additional opportunity costs if resources are borrowed from other value adding activities to carry it out. The benefits from the change must justify the cost.
The change effort requires resources. Research and development; quality control; quality assurance; production; and purchasing all play key roles in qualifying ingredient sources. In this case, “source” means the actual manufacturer of the API. In addition, many drugs are BCS class 3 for which dissolution test equivalence can be used as long as the BCS measurements are done in accordance with the appropriate (FDA) guidance.
Gamlen Tableting Ltd can offer a compliant testing service for BCS permeability measurements and checking of the properties of both the API (if needed) and the product.
Gamlen tableting can definitively show that the product made using the new API supplier is equivalent or not, in compaction terms and dissolution terms, to the product made by the existing supplier which reduces one of the major risk factors and enables lower procurement costs of APIs.