On Target With Antibody Drug ConjugatesSource: Piramal Enterprises Limited
By Vijay Shah, Executive Director & Chief Operating Officer of Piramal Enterprises
Few would dispute the fact that pharmaceutical formulation has become increasingly challenging. The difficulties all start with the ingredients used to make finished drugs. As more Active Pharmaceutical Ingredient (API) and excipient manufacturing moves offshore, particularly to India and China, there have been increasing complaints of variable quality and tightening supply. Ingredients have never officially been covered by existing pharmaceutical good manufacturing practices (GMPs), although different countries follow guidelines set by WHO, as well as ICH Q7.
Supply chain disasters of 2008, the heparin recalls and tainted glycerin tragedies, focused attention on the lack of systematic and harmonized global quality control standards for pharmaceutical ingredients.
Sweeping regulations in Europe and the US, namely the Falsified Medicines Directive and the FDA Safety and Innovation Act, aim to address this need, and improve the safety and quality of APIs and ingredients. Globalization of the market has also heightened awareness that the world’s regulators couldn’t possibly inspect every pharmaceutical ingredients plant or all the new API and ingredient manufacturing facilities coming online. Regulatory authorities, including EMA and FDA, collaborated on some API plant inspections, and have recognized a role for independent third-party auditors for API and ingredients facilities.
This has led to the development of formal cGMP guidelines for excipients and new options such as third-party supplier auditing and qualification programs.