The Importance of Knowledge Management in GMP

Knowledge Management (KM) is increasingly recognised as a critical pillar also in GMP-regulated areas in the pharmaceutical industry. For pharmaceutical executives and quality assurance professionals, effective KM can be a game-changer in ensuring compliance, driving continuous improvement, and enhancing operational efficiency. In fact, international guidelines like ICH Q10 (Pharmaceutical Quality System) list KM (alongside Quality Risk Management) as a key "enabler" of an effective quality system. ICH Q10 defines KM as a "systematic approach to acquiring, analysing, storing, and disseminating information related to products, manufacturing processes and components." In simpler terms, it means having the right knowledge available to the right people at the right time to make informed decisions. A robust KM supports regulatory and continual improvement in manufacturing and associated quality systems. Beyond compliance, it also drives operational excellence and creates synergy between quality and business outcomes. In the GMP environment, where processes can be complex and are heavily regulated, a strong KM practice ensures that hard-won lessons and process know-how are not just documented but shared and applied across the organization.

Knowledge Management as a Foundation of GMP Quality Systems

An effective Pharmaceutical Quality System (PQS) also relies on the organisation's ability to manage product and process knowledge throughout the product lifecycle. This begins in development and continues through tech transfer, commercial manufacturing, and even product discontinuation. By systematically capturing insight from development data, process validation, manufacturing experience, and deviation and change control history, companies build a knowledge repository that supports consistent, science-based decision-making. The goal is a 'learning organisation' culture where information is not siloed. Instead, knowledge flows freely between departments, sites, and even across contractors, enabling smarter decisions and proactive issue prevention. Notably, EU-GMP guidelines (Chapter 1) explicitly state that a PQS should ensure "product and process knowledge is managed throughout all lifecycle stages", underscoring that KM is not just a theoretical concept but an expected part of modern GMP operations.

When KM is embedded in daily operations, pharma companies see tangible benefits. Teams have up-to-date information at their fingertips, processes are performed consistently, and decisions are made based on collective organisational knowledge rather than isolated experience. Effective KM connects people, process, technology, and content: it involves not only good IT systems (for document management, search tools, etc.) but also well-defined processes and a culture that incentivizes knowledge sharing. In the following sections, some examples are explored of how KM supports key GMP quality system activities - from deviations to audits, training, and tech transfer - and how it ensures compliance, continuous improvement, and efficiency in pharmaceutical manufacturing:

Deviation Management and CAPA

Every GMP production facility faces deviations. What separates high-performing organisations is how they learn from those incidents. KM plays a vital role in the investigation and CAPA (Corrective and Preventive Action) process. When a deviation occurs, thorough investigation yields valuable knowledge about root causes. Capturing that knowledge in a database or report and disseminating it is crucial so that the same issue doesn't happen elsewhere or reoccur in the future. Some companies institute "lessons learned" sessions, bringing teams together to discuss in example what went wrong and how it was fixed. This practice is an example of KM enabling continuous improvement and compliance. Instead of each department or site learning the hard way, the organisation learns once and benefits everywhere. Over time, a rich knowledge base of past deviations and CAPAs allows for trend analysis: teams can proactively identify recurring issues and address systemic problems. A knowledge-enabled CAPA system also streamlines investigations; investigators can look up similar cases in the past and quickly hone in on likely root causes.

Audits and Inspections

Both internal audits and external audits or inspections generate a wealth of knowledge about a company's compliance status and areas for improvement. A good knowledge management approach ensures that findings are captured across the organisation. Rather than treating each audit in isolation, companies with effective KM create repositories of audit observations, responses, and "lessons learned" that are accessible to relevant personnel. For example, if a regulatory inspection at one manufacturing site uncovers an issue, that knowledge should be shared with other sites to proactively check and improve their own processes. This prevents repeating the same mistake elsewhere. And inspectors do also expect the company to have learned globally, not just locally. Additionally, KM aids inspection readiness: procedures and evidence (like training records, change logs, deviation reports) are well-organized and easily retrievable, which makes responding requests faster and more accurate. Importantly, knowledge management also includes keeping up with regulatory intelligence, that means staying informed of new guidelines or common inspection findings in the industry. This external knowledge should be shared internally (e.g. via newsletters or knowledge portals).

Training and Knowledge Retention

Human knowledge plays a big role in pharmaceutical operations, and effective training is how knowledge is transferred to people. Efficient KM complements training programs by ensuring critical know-how is documented and accessible beyond just one-on-one training sessions. Some expertise resides in operators, engineers, or scientists as 'tribal knowledge' - unwritten know-how gained through experience. If not captured, this tacit knowledge walks out the door when people retire or leave. A robust KM system addresses this by converting personal knowledge into explicit knowledge. Onboarding of new employees becomes faster and more effective, when they can readily access not only formal SOPs but also past project learnings, troubleshooting tips, and best practices. Poor knowledge sharing can make onboarding take months, whereas a culture of documenting and sharing knowledge can cut this time significantly. KM supports training by making learning a continuous, on-the-job process: updated procedures, "how-to" guides, and lessons learned from deviations are readily available for refresher training or just-in-time learning on the shop floor. Moreover, modern e-learning or knowledge portals can track who has read updates or for example taken quizzes, reinforcing competency. By managing knowledge, companies also preserve expertise during turnover; as one industry expert put it, without documentation and knowledge capture, "employees can leave and take knowledge with them" (5), hurting efficiency and continuity.

Technology Transfer and Process Scale-up

Technology transfer (tech transfer) is a critical phase in the drug lifecycle - whether transferring a process from R&D to manufacturing, or between manufacturing sites, or to a contract manufacturer. It is essentially a transfer of knowledge about how to produce a drug under GMP. Not surprisingly, poor KM is a top reason tech transfers fail or face delays. Effective KM in tech transfer involves systematically capturing all the product and process understanding and conveying it to the receiving site or team, including possible challenges and known pitfalls. When this knowledge is well-organized and made available, the receiving team can reproduce the process with minimal issues. If knowledge is missing or held only in the heads of a few experts, the transfer becomes error-prone.

Investing in KM practices and tools can lead to fewer batch failures, smoother tech transfers, faster onboarding of staff, and more agile decision-making. For QA professionals, KM is the glue that links all quality system elements - from document control to CAPA - into a cohesive, responsive whole. It transforms a compliance-driven culture into a learning culture. Companies that embrace KM often find that "knowledge multiplies by use": the more it's shared and applied, the more value it creates.

Conclusion

Knowledge management has become an important cornerstone in industry practices, also in pharma, particularly with the increasing complexity of processes and stricter regulatory requirements. Efficient knowledge creation, transfer, and application are essential for maintaining compliance, minimizing mistakes and risks, eliminating waste of time and driving innovation. An ECA course on "Knowledge Management in GMP" delves into the "what," "why," and "how" of KM in GMP, providing attendees with actionable insights to strengthen their systems and ensure long-term success in a competitive industry. 

Sources and further information:

1. ICH Q10 Pharmaceutical Quality System Guideline
2. ECA Academy: Is Knowledge Management a Part of the Pharmaceutical Quality System? (News, June 2025)
3. FDA/PQRI Presentation: A Regulatory Perspective on Knowledge Management and Quality Risk Management
4. European Pharmaceutical Review: "ICH Q10 knowledge management" (Christian Rack, 2019)
5. BioProcess International: "Integrating Knowledge Management into QMS" (Richter et al., 2025)
6. Quality Forward: CAPA Management in Pharmaceuticals (Blog, 2025)
7. Orca Lean: Why Operators Struggle With SOP Compliance (Blog, 2025)
8. Pharmaceutical Technology: "Addressing the Key Pitfalls Hindering Tech Transfer Success" (Lisete Pinto, 2022)