ABSTRACT
Change is inevitable in a pharmaceutical manufacturing operation. Vendors change processes, sources, and specifications for raw materials, equipment requires repair, service, or replacement, manufacturing locations are changed, batch sizes are increased or decreased, and advancements in technology are made that dictate changes to the operations. Changes made in a pharmaceutical manufacturing plant that have any potential to impact the safety, quality, purity, efficacy, or potency of a pharmaceutical preparation must be made in a way that assures these characteristics are not adversely impacted. Supporting data must be generated and appropriately reviewed; regulatory filing requirements must be considered and met; and any associated data need to be retained for the length of time the product being manufactured using the change is on the market. A written change control program in your company must account for all these aspects. Good manufacturing practice (GMP) regulations in Title 21 Code of Federal Regulations (CFR) 210 and 211 do not specifically state requirements for written change control procedures [1]. Such procedures are required by current good manufacturing practices (CGMP), however, and are included in the proposed CFR 210 and 211. This chapter will review many common industry change control practices. Readers are asked to review the practices listed and select those that best fit the needs and corporate culture of their company.
