Building a cGMP Quality System as a Growth Strategy

A small testing laboratory had been doing exploratory and other non-regulated work for a period of years. Then one day they were approached by one of their clients, a major pharma company, and told that an extensive amount of regulated work would come their way but only if they could build a cGMP quality system and then demonstrate compliance to cGMPs. Recognizing that this could be a strategic gateway to bigger and better things, the laboratory contracted with The Practical Solutions Group, LLC to make this happen.

Our challenges in making it happen included the following:

• The company’s size (five employees) dictated that there should be absolutely no unnecessary (from an operational standpoint) cGMP-related activities, documents, reviews, etc.
• The staff had neither experience with operating under cGMPs nor an appreciation regarding the effort to maintain a cGMP quality system once implemented. This meant that the company’s culture would have to be modified without stifling what had made the company successful.
• The company had no experience with hosting quality audits. At a minimum, this meant that, going forward, the staff would have to be taught to occasionally wear ties.

So what did we do to address these issues?

• For a start, we crafted procedures that were sized to fit a five-person company from the operational perspective while maintaining the expectations and requirements of cGMP compliance.
• Then we learned about the individuals’ professional strengths and weaknesses. Specifically, who has good attention to detail? Who intuitively understands the concept of compliance? Who is best at following directions? After a couple of meetings, we were able to help the company assign the cGMP roles to each staff member, based on the professional strengths and weaknesses observed and the requirements of the procedures.
• Before the cGMP quality system was considered to be finalized, procedures (and associated forms) and roles were vetted through active use to 1) confirm that the staff understood how to conduct the applicable activities and use the applicable forms, and 2) allow for required modifications to procedure/forms. This vetting also served as a training tool, giving the company staff an opportunity to make mistakes and learn from them without any regulatory impact.
• Finally, a thorough cGMP training session was held, wherein the newly-established activities were related to specific components of 21 CFR parts 210 and 211.
• The dress attire for the audits was the easiest to deal with and does not really count…

The outcome of our assistance was that the company passed their first cGMP audit with flying colors, resulting in the initiation of the drafting of a Quality Agreement with the auditing company even before the audit report was completed. Our client was quite happy – the strategic financial investment into the cGMP infrastructure paid off! And we felt great that our efforts translated into dollar signs for yet another client of ours.