Changes to an Approved Product: Chemistry, Manufacturing and Controls

| 01 April 2008

It is a huge achievement for any company to obtain licensing rights to an approved pharmaceutical product. Postapproval challenges are inherent in the marketing and distribution process. Of these, foreseen and unforeseen changes to the manufacturing process top the list. Sponsors of newly licensed products may encounter issues that were not fully realized during development, such as long-term stability issues, which only come to light within the first two years postapproval. Such unforeseen issues require corrective actions that usually impact the approved manufacturing process in one or more ways. At the same time, there are likely to be foreseen, legitimate needs to make changes to the approved product or production process. Postapproval changes can be relatively minor, such as like-for-like changes to manufacturing equipment; or they can be more critical, such as a change to the drug product container closure. The latter is common for products that undergo "lifecycle" management. For example, the company may, develop and obtain approval for the drug supplied in a vial, then plan to obtain approval for a prefilled syringe presentation for ease of patient use.


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