Right-Sizing GMP Compliance: Balancing Efficiency, Risk-Based Quality, and Regulatory Expectations in Life Sciences

The ECA Academy’s recent article on right-sizing GMP systems sparked a discussion within our team. As seasoned GxP consultants, we have seen firsthand how the drive of compliance can sometimes lead to overinterpretation, creating bloated processes and rising costs, without necessarily improving product quality or patient safety. 

Inspired by the ECA Academy’s perspective, this blog challenges conventional thinking and explores practical realities we have encountered in pharmaceutical manufacturing, validation, and audits. While we agree with much of their approach, we also highlight areas where companies need to push back against outdated practices and rethink what compliance should look like. 

When Compliance Becomes a Barrier to Quality 

Many in the industry have been questioning whether the approach to compliance is truly improving quality or just adding unnecessary complexity. Overinterpreting regulations often results in excessive controls, redundant checks, and documentation that prioritizes paperwork over product safety. Instead of preventing errors, these overcomplicated processes often increase the likelihood of mistakes. 

Regulators like the FDA and EMA have been advocating for a risk-based approach for years, yet companies continue to default to a “more is better” mentality. The updated ICH Q9(R1), which came into force in 2023, reinforces the need for structured risk assessments and evidence-based decision-making. Companies should focus on what truly impacts product quality and patient safety rather than blindly applying every possible control. A great example is the shift in aseptic manufacturing with Contamination Control Strategies (CCS). Instead of applying excessive and unnecessary measures across the board, companies are now focusing on high-risk areas like aseptic interventions and sterile connections. This targeted approach results in more effective and meaningful quality management. 

Challenging Process Improvement and Documentation Practices 

Continuous improvement should not mean implementing methodologies without questioning their fit. While Six Sigma is excellent for reducing defects and optimizing bottlenecks, applying it indiscriminately can be counterproductive, especially in complex manufacturing environments. The efficiency of a production system is not simply the sum of its parts. Instead, bottlenecks and overall process flow must be considered. 

Alternative approaches like Lean and the Theory of Constraints (TOC) often prove more effective in right-sizing activities. However, we have seen companies mistake “leaning out” for cutting corners, resulting in compromised documentation and diluted quality checks. Process improvement efforts should be led by professionals who understand the complexities of pharmaceutical manufacturing. 

Simplifying documentation is another long-overdue change. Bloated batch records, SOPs that read like legal contracts, and excessive cross-referencing create unnecessary burdens. However, the issue is not just document length or clarity. A well-structured documentation system must eliminate redundancy and ensure that policies, SOPs, and work instructions serve distinct purposes. Too often, these documents become blurred, making training and compliance unnecessarily difficult. 

Many companies believe that digitizing documentation will solve these issues, but that is a misconception. A bad process remains a bad process, even if it is digital. We have seen companies invest millions in eQMS solutions, only to find that their documentation headaches did not disappear but instead moved from paper to a screen. If digital transformation is not approached strategically, it simply adds cost without improving efficiency. 

Rethinking Training, Culture, and Oversight 

A compliance-driven mindset without critical thinking leads to inefficiencies and audit failures. Too often, deviations and mistakes occur because employees do not understand the "why" behind GMP requirements. Training that focuses solely on procedural steps rather than on the underlying purpose, such as sterility assurance, contamination control, or data integrity, leads to rigid execution without real understanding. 

The MHRA’s push for Quality Culture highlights the need to go beyond procedural compliance. Employees should be encouraged to critically evaluate processes instead of blindly following outdated practices. Companies must foster an environment where questioning inefficient or contradictory procedures is seen as a strength, not a risk. 

Similarly, outsourcing should not be an excuse to offload responsibility. While it can improve efficiency, the Marketing Authorization Holder (MAH) remains accountable for product quality. Weak oversight of vendors has led to numerous compliance failures. Companies must challenge their vendors, enforce strong quality agreements, and maintain clear accountability to ensure compliance. 

So, Where Do We Stand? 

Right-sizing GMP is not about cutting corners; it is about cutting the noise. It is about challenging outdated practices, questioning inefficient processes, and focusing on what truly protects product quality and patient safety. Companies that cling to the "we have always done it this way" mentality or that cannot think critically risk being left behind. 

As GxP consultants, our role is to push companies toward a leaner, smarter, and more effective compliance framework. That means not just accepting the status quo but continuously questioning whether each requirement, control, and process truly adds value. The industry must shift from compliance for compliance’s sake to compliance with purpose. 

Because in the end, efficiency is not the enemy of quality. Waste is. 

Check out their full article here: ECA Academy – Right-sizing GMP Systems.