For export-oriented pharmaceutical companies, a PIC/S GMP certificate serves as a strategic passport to global markets and is crucial for fostering trust and facilitating international trade. This blog offers a clear roadmap for navigating PIC/s GMP readiness, turning regulatory challenges into competitive advantages.

PIC/S GMP Readiness: A Gateway to Global Markets

The Pharmaceutical Inspection Co-operation Scheme (PIC/s) unifies Good Manufacturing Practice (GMP) standards and inspection protocols among its member authorities, allowing for mutual recognition of GMP certificates. This reduces duplicate inspections and administrative burdens, expediting market access across Europe, Asia-Pacific, and the Americas. Certification conveys to global stakeholders that a company meets high international standards for quality, safety, and efficacy.

PIC/S GMP vs. WHO GMP

Transitioning from WHO GMP standards to PIC/S signifies a substantial evolution for companies, involving stricter requirements in key areas.

Quality Risk Management (QRM): is mandated by PIC/S to implement a formal and proactive method for identifying and controlling risks throughout the product lifecycle.

Pharmaceutical Quality System (PQS): necessitates a more thorough and integrated framework, with clear accountability assigned to senior management.

Sterile products: are regulated by PIC/S Annex 1, known for establishing stringent global standards for sterile manufacturing and contamination control.

Documentation and data integrity: require robust controls, comprehensive audit trails, and strong governance to maintain data completeness, consistency, and reliability.

Roadmap to PIC/S GMP Certification

A structured roadmap is essential for achieving PIC/s GMP readiness and ensuring a successful inspection outcome.

Phase 1: Assessment & Planning:

• Objectives: Conduct a gap analysis based on the PIC/s GMP Guide, evaluating the Quality Management System (QMS), facilities, equipment, and documentation. Create a comprehensive and prioritized action plan.
• Zenovel’s Support: Expert consultants conduct a thorough assessment to identify compliance gaps and develop an effective strategy in the context of PIC/s GMP Readiness.

Phase 2: System Development & Upgradation

• Objectives: Enhance your Pharmaceutical Quality System (PQS) by integrating quality assurance (QA), quality control (QC), and risk management. Upgrade facilities and equipment to minimize contamination and errors, while implementing digital systems for improved data integrity and traceability.
• Zenovel’s Support: Assistance in developing or enhancing a QMS to ensure compliance with PIC/S standards, alongside guidance on facility design and upgrades to meet GMP standards while maintaining ongoing production.

Phase 3: Team Qualification & Culture Building

• Objectives: Implement a training program focused on GMP fundamentals, role-specific procedures, and hygiene to cultivate a culture of quality across the company, ensuring all employees recognize their influence on product safety.
• Zenovel’s Support: Expert-led training programs are designed to ensure that personnel across all levels comprehend and adhere to PIC/S standards, thereby fostering a sustainable culture of quality.

Phase 4: Pre-Inspection Readiness

• Objectives: Conduct mock inspections to replicate the actual audit process, which involves reviewing documents and interviewing personnel. Recognize concealed shortcomings, train staff for confident responses, and ensure all records are meticulously organized.
• Zenovel’s support: Pre-inspection readiness and mock inspections provide services that simulate the inspection process to identify vulnerabilities, train teams, and enhance confidence for the official audit.

Phase 5: Formal Inspection & Continuous Compliance

• Objectives: Submit the application to the national regulatory authority and conduct the official inspection. Upon successful approval, remain vigilant by keeping abreast of PIC/S revisions and ensuring continuous compliance through internal audits and management reviews.
• Zenovel support: Ongoing consulting and audit support provides strategic guidance for navigating formal inspections and offers post-certification assistance to maintain compliance with evolving standards.

Zenovel Strategic Approach to Overcome Burden:

Navigating compliance alone can be challenging. Zenovel, with over two decades of global GxP experience, transforms PIC/s expert compliance into a value driver. Our team of experienced consultants and auditors utilizes a risk-based approach to enhance quality and regulatory outcomes. Our recent track record includes assisting a pharmaceutical manufacturer in China with PIC/s certification. Achieving PIC/s GMP compliance is seen as a strategic investment, improving supply chains, building trust with partners, and establishing leadership in pharmaceutical quality.

Figure 1: Zenovel Offers Quality and Expertise

Ready to Achieve PIC/s GMP Readiness and Global Compliance?

Achieving PIC/s GMP certification signifies a commitment to excellence, enhances reputation, and ensures patient safety. PIC/s GMP readiness is supported by Zenovel’s GMP experts through every phase—from gap analysis and inspection preparedness to maintaining standards post-certification—providing the clarity and confidence required for global success.