Product Manufacturing—Life Cycle Phases

MedicinesThere are four stages in product manufacturing life cycle that include designing and developing the product, transferring technology to commercial-scale production, undertaking commercial manufacturing, and dealing with product discontinuation.

  • Product Development: The goal of development activities is to design a product and optimize its manufacturing process to consistently deliver the intended performance and meet the needs of patients, healthcare professionals, regulatory authorities and internal customers’ requirements. It consists of (a) PRODUCT Development—Material Design Space, and (b) PROCESS Development—Process Design Space.
  • Technology Transfer: The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach and ongoing continual improvement.
  • Commercial Manufacturing: The goals of manufacturing activities include achieving product realization, establishing and maintaining a state of control and facilitating continual improvement. The quality system will provide assurance that the desired product quality is routinely met, suitable process performance is achieved, and the control sets are appropriate. Another responsibility of manufacturing activities is to identify and evaluate improvement opportunities and ensure that the horizon of knowledge is continually expanded.
Product Discontinuation: The goal of product discontinuation activities is to manage the terminal stage of the product life cycle effectively. For product discontinuation, a pre-defined approach is used to manage activities such as retention of documentation and samples and continued product assessment (e.g., complaint handling and stability) and reporting in accordance with regulatory requirements.