Good Manufacturing Practices (GMP) audits are conducted by the U.S. Food and Drug Administration (FDA) to ensure compliance with federal regulations. Good manufacturing practices are established by FDA to ensure the manufacture of safe and effective pharmaceutical products for the general population to consume and use. The procedures followed during a GMP audit serve to identify as to whether or not a manufacturer has control over its processes.
When a GMP audit is conducted, an auditor begins by examining the pharmaceutical manufacturer’s general controls. An organization chart is usually supplied by the company and allows the auditor to see that a Quality Assurance department exists and is separate from manufacturing operations. Beyond the company’s organization, standard operating procedures (SOPs) and training records are examined. Robust SOPs are a necessary part of GMP, as they confirm that all operations are performed in the same manner every time.
Auditors are responsible for determining whether a manufacturing plant is acceptable for the production of pharmaceutical products. To this end, an audit will include an in-depth look at the environmental controls implemented by the company. Such controls include measures to verify that the air is clean and no standing water is present in the facilities. Standing water leads to microbiological growth that raises the potential for product contamination. In addition to environmental concerns, a part of looking at the facility control includes a review of the company’s pest control systems.
The processes which control the equipment used in the manufacturing, packaging and testing of pharmaceutical products undergo scrutiny as part of a GMP audit. An auditor needs to identify the company’s procedures for storing and cleaning equipment. Clean equipment is an important part of preventing cross-contamination and ensures residue from a product already manufactured is effectively removed. Besides storage and cleaning, an auditor will examine a company’s calibration and qualification procedures. These procedures are necessary to prove that every piece of equipment used in production performs its intended function.
Material and component control plays a definite role in a company’s compliance with GMP. When materials are received by a pharmaceutical manufacturer, they need to be sampled and tested in order to prove that the material is not incorrectly labeled and also that it meets the right level of efficacy. Part of a GMP audit is a review of the quality systems used to make sure that material is correctly received. Another vital part of a GMP audit is to look at the material storage systems and inventory control.
When an auditor examines a company’s operational controls, he is generally looking at such areas as validation, material retest and in-process sampling. Validation is a quality function which serves to provide documented evidence that the procedures to manufacture, package and clean products actually perform their intended functions. During an audit, validation protocols and reports are requested and reviewed. In-process sampling and testing are actually used in product validations, but are also conducted during post-validation runs.
Finished Product Control
An important GMP audit procedure is the review of finished product control. The control over what happens to a finished product includes: finished goods testing, storage, distribution, product release and the handling of complaints. Whereas these are all important components of finished product control in their own right, the way a company handles complaints is especially scrutinized during a GMP audit. By looking at issues the company has faced, and the manner in which the problems were addressed, an auditor will develop a good sense of how effective the Quality Assurance department is at finding root causes of problems and effectively dealing with them.