Quality Oversight Plans: Key Strategies for Effective Oversight in Pharma Manufacturing

“Quality oversight isn’t just about compliance – it’s about building successful partnerships and driving down costs,” asserts Stephanie Gaulding, Managing Director at Pharmatech Associates.

Stephanie Gaulding, Managing Director at Pharmatech Associates, brings over 30 years of experience in quality management within the life sciences industry. Her expertise in quality systems, regulatory compliance, and supplier relationship management provides valuable insights into effective quality oversight practices.

In a recent PharmaSource podcast episode, Stephanie explains why robust quality oversight is crucial for successful supplier relationships and cost reduction in pharmaceutical manufacturing.

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Early Integration of Quality

Gaulding emphasizes the importance of integrating quality oversight early in the development process, especially when working with contract development and manufacturing organizations (CDMOs). “Involving Quality early sets up the development program in a manner in which… you’ve got somebody in that role that’s really championing the quality elements, looking for data integrity issues, getting them resolved,” she explains.

This proactive approach to quality oversight ensures that when data from early development programs is included in a product approval application, all necessary information is present and gaps don’t need to be filled retrospectively.

“The reality is, involving Quality early sets up the development program in a manner in which working through that relationship, especially with a CDMO… you’ve got somebody in that role that’s really championing the quality elements.”

Implementing Effective Quality Oversight

When it comes to selecting and managing CDMO partnerships, Gaulding recommends a comprehensive quality oversight approach that goes beyond technical capabilities and financial stability. She advises considering cultural fit and communication styles as part of the oversight strategy:

“Look at, you know, how they like to handle and communicate. Are they a little bit lax about their communication? Are they really formal and structured with their communication? What does your organization prefer to have?”

Gaulding suggests creating a formal quality oversight plan that outlines:

1. General information about the partnership
2. How the two groups will interact for effective oversight
3. Data platforms to be used for quality monitoring
4. Expectations around timeliness of communication in quality-related matters
5. Key Performance Indicators (KPIs) and performance criteria for quality oversight

The Business Case for Quality Oversight

When it comes to convincing stakeholders to invest in comprehensive quality oversight upfront, Gaulding recommends using the “Rule of 10”:

“If you detect a defect early in the process… you articulate kind of what that defect costs you. So you take into account time, materials, testing… and then you talk about the level of quality. And if you don’t detect it then, then you detect it later in the process… your costs go up tenfold each time.”

This simple rule demonstrates how costs can escalate quickly when quality oversight is inadequate. Gaulding shares an example where insufficient quality oversight led to a manufacturing issue, resulting in a recall of over 100 batches of sterile product and billions of dollars in losses.

Download your copy of the Outsourcing Oversight Plan template

The Future of Quality: Digitization and AI

Gaulding sees great potential in the application of digitization, machine learning, and AI in enhancing quality oversight:

“I see this really bright spot for us where, if we can embrace the technology… we could see a pretty dramatic shift in the way that data is handled, the way it’s used.”

She envisions a future where technology can assist in identifying trends and patterns that might be missed by human oversight alone, potentially flagging quality issues before they become critical problems.

However, she notes that the lack of standardization in data exchange between different equipment and systems remains a significant challenge in implementing comprehensive digital quality oversight across the industry.

Learning from Other Industries

As an active member of the American Society for Quality (ASQ), Gaulding advocates for learning from other industries’ quality oversight practices, including those in less regulated sectors:

“The opportunity to have the conversations and to… do some benchmarking, just even on the cost of quality. So how do you guys look at this… do these really big data, rich calculations, or have you gotten to smaller calculations?”

She encourages pharmaceutical quality professionals to challenge the status quo and look for innovative approaches to quality oversight, even if they come from outside the industry.

In conclusion, Gaulding’s insights highlight the critical role of comprehensive quality oversight in optimizing pharmaceutical manufacturing and supply chain management. By integrating quality oversight early, building strong outsourcing partnerships with clear oversight mechanisms, making the business case for quality investments, embracing new technologies for enhanced oversight, and learning from other industries, pharmaceutical companies can drive down costs and improve their overall performance.