Comparatively Speaking: cGMP vs. ISO

By: Anthony J. O'Lenick Jr., Siltech LLC

Posted: August 31, 2010

Tony O'Lenick draws on the expertise of Joe Albanese, technical marketing manager of personal care for 3V Inc., in this discussion of the differences between current Good Manufacturing Practices (cGMP) compliance and International Standards Organization (ISO) certification.

There was a time when cGMP and ISO were further apart. The industry used to say that having cGMP compliance was more than half way to obtaining ISO certification. However, having ISO certification was nowhere near meeting the requirements for the more stringent cGMP guidelines. This was because cGMP covered not only good manufacturing practices, but also all related activities such as: processing equipment and procedures, cleanliness, packaging, holding/storing raw ingredients, testing, quality control, training of personnel, etc.—specifically for the pharmaceuticals industry.

The later ISO certification covered most other aspects of any company’s operations such as finances, marketing, procurement, sales, etc., regardless of the type of business and with comparatively little regard for manufacturing operations. Of course, many companies do not actually manufacture anything. Today, this author believes that both cGMP and ISO incorporate certain key elements from one another. Following are some of the other similarities and differences between the two.

Similarities
The intent of both cGMP and ISO is to establish “quality assurance” systems. Throughout the years, the primary purpose and intent of these programs remains unchanged. Both require written policy manuals, procedures, maintenance of records and documents to assure products meet their design specifications. Both also use internal and external audits as periodic checks for conformity to guidelines.

It is important to note that quality assurance (QA) is not the same as quality control (QC). The confidence that products will consistently meet the highest standards is provided by an overall QA program. In cGMPs, QC is one essential element of the total QA program. The QC program details the actual steps taken to assure quality. QC includes setting product specifications and providing analytical and other test methods, as well as establishing sampling frequency and procedures so that only quality products reach the marketplace.