(12e) Effective Technology Transfer of Pharmaceutical Capsule Manufacturing

A pharmaceutical capsule is currently produced at two different manufacturing sites, one in the US and the other in Europe. Since manufacturing at both sites is being discontinued, production needs to be transferred to another site in the US. The manufacturing processes at both current sites, although similar, have some distinct differences in the way the pharmaceutical powder is granulated prior to filling the capsule (encapsulation). Since the new site will be the only site for worldwide production, the new manufacturing process needs to be harmonized (demonstrating that the new process is equivalent to both current processes). Process equivalence is also important to demonstrate for the required FDA and multinational filings before the new site can be approved. This paper discusses the key aspects of the powder granulation and encapsulation unit operations and how sound technology transfer principles are used to manufacture an equivalent capsule product.