On March 30, xCellarate Managing Director and Principal Fenton Fong presented the Redica Systems webinar, “How to Build and Implement a QMS for Small Pharma and Biotech Firms.” Part I covered the basic GMP requirements underlying effective quality management systems (QMS) and the typical challenges small pharma firms face when building a QMS.

After reviewing the gap analysis process, Fong switched gears and provided background on “a holistic approach to quality management development,” beginning with a look at ICH Q10: Pharmaceutical Quality System, which he characterized as embodying a holistic approach.

“When ICH Q10 was published it represented the culmination of different sources of thinking and philosophies about the concept of quality and achieving quality,” he said. “ICH Q10, what it is, is an effective model for a pharmaceutical quality system.”

[Related: Download a full recording of the webinar, including the presentation, here.]

Fong views ICH Q10 as a strong foundation for small pharma and biotech companies to use when building a QMS. Further, ICH Q10 is part of a paradigm shift away from a prescriptive approach to one that takes a comprehensive quality systems approach over the entire product lifecycle.

[Related: Check out a clip of Fenton Fong providing background on ICH Q10 from the webinar.]

Three Pillars of the ICH Quality Vision

ICH Q8: Pharmaceutical Development and ICH Q9: Pharmaceutical Quality System are also key. As a tripartite guideline, they provide a complementary, systematic, risk- and science-based approach to pharmaceutical manufacturing and development.

“I find that the adoption of this concept of this trio is critical,” Fong said, noting that in his experience, these guidelines have not been widely adopted despite being 15 years old.

“The philosophy of the trio is that good scientific development (Q8) in combination with quality risk management (Q9) work well together with the quality management system in Q10 to improve drug quality and efficacy of pharmaceutical manufacturing,” he said. “Comprehensive implementation of these three guidelines is essential to achieve the ICH Quality Vision.”

Honing in on ICH Q8, he explained that “Q8 adopts the concept of Quality by Design, or QbD.”

QbD is:

A systematic approach to drug development
Based on sound science
Risk-based
Built into the product from the beginning instead of a “Quality by QC” approach

Figure 1 shows Unified Concepts relating to quality within ICH Q8.

Figure 1 ICH Q8 Unified Concepts — **FIGURE 1 | ICH Q8 – Unified Concepts**

QMS Meets QRM

Regarding ICH Q9, “quality risk management adoption within the industry is growing. From my experience consulting in industry, there really is widespread use compared to 20 years ago. Having said that, though, there is ample opportunity for improvement, especially for growing and small companies.”

Fong pointed out that the pharma/biopharma industry traditionally has lagged behind related industries when it comes to risk management. For example, ISO 14971 and Hazard Analysis and Critical Control Points (HACCP) have been well established within the medical device and food industries respectively.

But risk-based thinking is especially critical for small pharma companies.

“A quality management system for small and growing biotech companies should adopt the concept of risk-based thinking across operations,” he stated.

Tools that can be used for risk assessment include:

SWOT analysis
FMEA
Ishikawa diagrams
Fault Tree Analysis
HACCP
Etc.

“There is really no one way to conduct a risk assessment,” Fong said. “What is important is that you documented that you conducted a risk assessment. That it took place. And document the thinking that went behind it to arrive at the conclusions you did.”

When an auditor comes onsite and sees a complete risk register that documents the risk assessment, it provides reassurance about the company’s processes.

“What I find is that few companies have an understanding of the full approach, the holistic philosophy of the tripartite guidance,” he said, eventually adding, “while it’s not mandatory, compliance with the tripartite model is indicative of quality excellence within an organization.”

[Author’s note: Part III will look at the documentation required for a robust QMS.]

[Related: Download a full recording of the webinar, including the presentation, here.]