Product Development Laboratory

Preparing a Label in a Lab

In coordination with others, this group is responsible for defining the details and specifications of the manufacturing process and final product. Working with clinical research, they determine the form of the product (tablet or injectable), how it will be produced, the non-active ingredients (such as lactose or sucrose sugars), and the best way to make it. They identify critical control parameters that are used in validating the process.

Example of a GMP expectation that applies to Product Development

The written process instructions describe the in-process controls to be conducted in order to assure batch uniformity and integrity.

Example of GMP requirements specific to this GMP expectation

  U.S.

• To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch. Such control procedures shall be established to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. [211.110(a)]

  Canada

• Master formulae...include the instructions for any in-process controls, along with their limits. [C.02.011 # 24.8]

  European Union

• The processing instructions should include the instructions for any in-process controls with their limits. [EU # 4.15(d)]

• There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded. [EU # 4.23]