The Qualified Person (QP) plays a critical role in pharmaceutical supply chains, acting as the final gatekeeper to ensure that every batch of medicine released meets regulatory and quality requirements. The QP is legally responsible for ensuring that medicinal products comply with Good Manufacturing Practice (GMP) and that patient safety is always the top priority.
Beyond batch release, the QP’s role extends to supplier oversight, risk management, regulatory compliance, and inspection readiness. In an era of complex global supply chains, outsourcing, and evolving regulations, the QP’s expertise is more crucial than ever.
🎯 Key Responsibilities of the Qualified Person
A QP is not just a regulatory sign-off—it is a role embedded in risk management, quality assurance, and regulatory compliance.
1️⃣ Batch Certification – The Legal Duty of a QP
Before a batch of medicine can be placed on the market or used in clinical trials, a QP must certify that it meets GMP and marketing authorisation (MA) requirements.
📋 Key elements of QP batch certification:
✔️ Ensuring that all manufacturing steps comply with GMP.
✔️ Verifying that raw materials, intermediates, and finished products meet quality specifications.
✔️ Confirming that analytical testing and stability studies support product integrity.
✔️ Ensuring that the batch record has been reviewed, approved, and correctly documented.
⚠️ Regulatory risk: If a QP releases a non-compliant batch, it can result in regulatory enforcement actions, recalls, and patient harm.
📌 Suggested Image: A flowchart of the QP batch release process, from manufacturing to distribution.
2️⃣ Supplier and Contract Manufacturer Oversight – Managing Risk in an Outsourced World
Pharmaceutical companies increasingly rely on third-party manufacturers (CMOs) and suppliers, making QP oversight crucial to maintaining compliance.
🔍 How QPs manage supplier and CMO risk:
✔️ Conducting supplier audits to assess GMP compliance.
✔️ Ensuring that quality agreements define clear responsibilities.
✔️ Evaluating the supply chain for vulnerabilities such as counterfeit ingredients or contamination risks.
✔️ Implementing corrective and preventive actions (CAPAs) if deficiencies are found.
⚡ Case Study: A QP discovered that an API supplier had changed a key manufacturing step without notifying regulators. Immediate action prevented a potential product recall and a serious regulatory violation.
📌 Suggested Image: A global map highlighting the complexity of international supply chains and QP oversight responsibilities.
⚖️ Regulatory Compliance – Navigating a Shifting Landscape
3️⃣ The Evolving Role of the QP in Compliance & Regulation
QP responsibilities are defined by EU and UK law, but global regulatory expectations are changing.
📜 Regulatory frameworks governing QPs:
📌 EU GMP Annex 16 – Defines QP batch certification and verification responsibilities.
📌 UK MHRA QP Guide – Emphasises risk-based decision-making in QP duties.
📌 ICH Q7 – Covers QP requirements for active pharmaceutical ingredients (APIs).
⚠️ Emerging regulatory trends affecting QPs:
🔸 Greater scrutiny of data integrity and electronic batch records (EBR).
🔸 More stringent oversight of QP responsibilities in outsourced manufacturing.
🔸 Regulatory pressure to enhance risk-based decision-making in batch release.
📌 Suggested Image: A timeline of QP regulatory changes and future trends.
🛠️ Challenges Faced by QPs – Balancing Compliance with Business Pressures
A QP must uphold quality and compliance, often in the face of commercial and operational pressures.
4️⃣ Common Challenges QPs Face in the Pharmaceutical Industry
🚨 Pressure to release batches quickly – Tight deadlines vs. compliance risks.
🚨 Managing regulatory uncertainty – Adapting to shifting global regulations.
🚨 Handling deviations and non-conformances – Deciding when a batch can still be released.
🚨 Training & competency – Ensuring QPs remain up to date on emerging regulations and industry best practices.
⚡ Case Study: A QP refused to certify a batch due to unexplained out-of-specification (OOS) results. Despite pressure from management, the QP’s decision prevented a major regulatory violation and protected patient safety.
📌 Suggested Image: A visual comparison of a compliant vs. non-compliant QP decision-making process.
🛡️ Risk-Based Decision Making – When Should a QP Say “No”?
A QP is often faced with grey areas where regulatory guidance may be unclear or open to interpretation.
5️⃣ Factors a QP Must Consider Before Batch Release
📊 Risk vs. Benefit – Does the risk of releasing outweigh the risk of withholding?
📜 Regulatory Compliance – Are there potential violations of GMP, MA, or regulatory commitments?
💊 Patient Safety – Could this decision compromise public health?
📂 Investigation Outcomes – Have all root causes and CAPAs been addressed?
🚨 Red flag: Releasing a batch without sufficient supporting data can lead to regulatory action, product recalls, and legal liability.
📌 Suggested Image: A decision-making framework for QPs assessing batch release risks.
📈 The Value of a QP – Why They Are More Than Just a Compliance Function
A QP adds value beyond regulatory compliance, playing a strategic role in business efficiency, reputation, and innovation.
6️⃣ How QPs Contribute to Business Success
✔️ Regulatory Confidence – Ensuring seamless inspections and licensing approvals.
✔️ Quality Culture Leadership – Embedding GMP principles across the organisation.
✔️ Continuous Improvement – Identifying trends in deviations, CAPAs, and supply chain risks.
✔️ Crisis Management – Making critical decisions in product recalls or regulatory crises.
⚡ Case Study: A pharmaceutical company with a proactive QP strategy saw a 40% reduction in batch failures and a faster regulatory approval process for new products.
📌 Suggested Image: A success story infographic showing the impact of a strong QP-led quality system.
🤔 How Well Is Your Organisation Leveraging the Expertise of Its QPs?
🔹 Are your QP decisions fully independent, or is there commercial pressure influencing quality decisions?
🔹 How robust is your QP oversight of suppliers and contract manufacturers?
🔹 Does your company provide ongoing training and support for QPs to stay ahead of regulatory changes?
📢 Contact Pharma Quality Services Limited today to strengthen your QP oversight and compliance strategy!
