Paving the Way Forward
Jebsen & Jessen Ingredients in Indonesia achieves GDP certification and is licensed to enter the pharma ingredients business
Jebsen & Jessen Ingredients in Indonesia successfully obtained licenses from the Food and Drug Supervisory Agency (BPOM), marking the end of a six-month journey that began in April.
The business unit needed a Pharmaceutical Wholesaler (PBF) license and a Good Distribution Practice (CDOB) certification in order to be a licensed distributor of active pharmaceutical ingredients. This process began with an application for the PBF license in the wholesale trade of pharmaceutical ingredients for humans and animals which was successfully received in May with permanent validity given the company’s continuation.
To qualify for CDOB certification, the business unit put in place standard arrangements on quality management, organisational and personnel management, building and equipment, operations, and self-inspection. These requirements were implemented with training to all parties involved in distributing pharmaceutical goods to end customers. In parallel, Jebsen & Jessen Ingredients in Indonesia must also have a licensed pharmacist responsible for Quality Control and Quality Assurance.
After BPOM reviewed the submitted documents and conducted a detailed on-site audit, the five-year CDOB license was awarded in October. With these licenses, Jebsen & Jessen Ingredients in Indonesia is now ready to enter the active pharmaceutical ingredients market!