Developing Effective Procedures In Drug Manufacturing

By Jeff Hall and Lisa Hawkins

Needing to develop or update your procedures? Are you sitting at your computer starting to write procedures for every subject discussed in regulations and standards, addressing each statement with a procedural step? Put the procedure template away. The first step to writing effective procedures is in understanding WHY you are writing that procedure.

As everyone knows, a QMS/GMP/SOP controlled document system is made up of a certain set of procedures that get the job done, right? Let’s challenge that idea. An effective documentation system is not a series of procedures: it is a process by which the organization will maintain a state of control that ensures patient safety by manufacturing products that are safe and efficacious. This doesn’t happen because of procedures. Procedures are functional tools of a controlled process but are not the entirety of a control system.

Before fingers are ever put to a keyboard to start writing a procedure, the organization should evaluate its place in the product lifecycle, the type of product it is manufacturing, and the resources it has available to implement effective procedural controls. An organization with fewer than 50 people will end up with a different system than a multi-site organization with 50 people in one group. The path to get there, however, can be the same regardless of the organization.

This paper explores the change management, risk management, and knowledge management processes and how they integrate with one another to help you construct proper procedures for your organization.