A comprehensive quality management system (QMS) is a necessity for any pharmaceutical company developing and producing product for market, regardless of company size.

In the March 30 Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms,” xCellarate Managing Director and Principal Fenton Fong discussed how small pharmaceutical firms can take a holistic approach to developing a robust QMS.

[Related: The webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms,” can be accessed here.]

Fong has over 25 years of corporate and consulting experience and pharma biotech and related industries. He has engaged in numerous audits, GMP and QMS remediation projects, both domestic and international. His company, xCellarate, provides consulting solutions to complex challenges in the areas of CMC, product development, quality management systems, audits, and regulatory filing applications.

But First, a Review of GMP Requirements

He began the webinar by listing the ten basic GMP requirements:

Clearly defined and systematically reviewed processes
Validation of critical steps/processes
Appropriate resources: personnel, buildings, equipment, materials
Clearly, written procedures
Trained operators/personnel
Complete records
Complete, proper investigations
Proper storage and distribution
Clean, organized environment
Quality oversight to review above activities

Further, for an organization to meet these requirements, they must have a strong foundation of systems and processes including, but not limited to, change control, CAPAs, document management, personnel training, etc.

But small companies can face challenges when it comes to building a QMS. Typical challenges Fong sees are:

An immature or undefined culture of quality
Limited budgets for suitably experienced Quality experts
Grey area concerning the level of quality needed for early-stage product development (e.g., how robust are specifications?)
Building good habits at the beginning or starting off with bad habits

“So, where do you go from here as a small company?” he asked. “Well, I always suggest beginning with a gap analysis of your existing QMS.”

[Related: Watch Fenton Fong discuss these challenges in a clip from the webinar.]

Mind the Gap for a Strong QMS

In this gap analysis, Fong recommends speaking with key personnel in quality, engineering, production, and management to understand the roles of the personnel/departments involved. The goal of the gap analysis exercise is to identify and define a roadmap remediation plan to move from the current state to a desired state.

Next, review all existing GMP documentation such as SOPs, quality agreements, validation documents, etc.

“You also want to identify and define all key processes that take place in your organization and go through the exercise of process mapping,” he said. This involves a physical walkthrough of the entire facility, including warehouse areas, gowning rooms, production spaces, QC labs, and packaging/labeling areas.

“You want to identify and map out all GMP-impact processes using flowcharts,” Fong explained.

Once process mapping is complete, it is time to evaluate the findings. This involves identifying major and minor gaps and developing a priority list that uses a ranking system. Next, an action plan to address these gaps must be created. And finally, responsibilities need to be assigned and teams/subteams designed.

“Once you have this, it is Go Time,” Fong said. “And the work begins.”

[Author’s Note: The next installment covers more of the webinar, primarily how to use ICH Q10 Pharmaceutical Quality System to take a risk-based approach for building a QMS.]

[Related: The webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms,” can be accessed here.]