“A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.”
–International Society for Pharmaceutical Engineering. Good Manufacturing Practice (GMP) Resources. Accessed May 2014.
It’s not enough to create a useful product. That product must be made legally and ethically. This is especially true in science and pharmaceuticals. One way to ensure a legally and ethically made product is through current Good Manufacturing Practices (cGMP).
According to the World Health Organization, cGMP is “the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.”
One of the most important and time-consuming aspects of cGMP is documentation. As shown by Andra Miller of the Biologics Group at the Gene Therapy Vector Production Conference, documentation consists of two key components, Standard Operating Procedures (SOPs) and records.
A company can set and maintain cGMP documentation through SOPs. SOPs are written guidelines that explain each step of production. SOPs are detailed, methodical instructions. The purpose of SOPs is to ensure that every employee completes every step of an operation in the same manner. This is especially important in a pharmaceutical setting because inconsistent methods could skew results. Companies create SOPs and share them with their employees before anyone steps foot in the lab to prevent method errors and data inconsistencies.
A second way a company can adhere to cGMP documentation is through records. Unlike SOPs, which companies create before production begins, records are created during and after operational processes. For example, as an employee finishes a task or step in a project, he or she will record its completion. This serves as verification that the authorized person conducted the procedure at the proper location and time. Conversely, if a task does not occur as expected, there must be a record showing what happened and why.
Documentation is one of the most important steps of cGMP. It comprises SOPs and records. By focusing on documentation and its two components, a company can set and maintain good practices for the development of its product. In the world of pharmaceuticals, good practices make perfect.