Complete PIC/S Compliance Solution for Pharmaceutical Manufacturing

PIC/S (Pharmaceutical Inspection Co-PIC/S (Pharmaceutical Inspection Co-operation Scheme) is an international cooperation framework for pharmaceutical regulatory authorities that harmonizes Good Manufacturing Practice (GMP) standards across 56+ member countries. PIC/S applies to manufacturers of medicinal products, including pharmaceutical companies, contract manufacturers, API producers, and facilities involved in sterile and non-sterile drug production. Companies exporting pharmaceuticals to PIC/S member countries must comply with PIC/S GMP guidelines to pass regulatory inspections and maintain market access.

PIC/S GMP requirements are organized into 17 key elements covering the complete pharmaceutical quality lifecycle:

• Element 2: Pharmaceutical Quality System, Quality Risk Management, and Management Responsibility
• Elements 2.5-2.6: Internal Audits (Self-Inspection) and Product Quality Review
• Element 3: Personnel and Hygiene
• Elements 4-5: Buildings, Facilities, and Process Equipment
• Element 6: Documentation and Records
• Element 7: Materials Management
• Element 8: Production and In-Process Controls
• Element 13: Change Control
• Element 14: Rejection and Re-Use of Materials
• Element 15: Complaints and Product Recall
• Elements 16-17: Contract Manufacturers, Distributors, and Re-Packers

Each element requires documented procedures, controlled processes, and comprehensive record-keeping to demonstrate compliance during inspections.

QT9 QMS provides comprehensive coverage of all 17 PIC/S elements within a single integrated platform. The software automates critical compliance functions including:

• Document Control for validated procedures and records (Element 6)
• Risk Assessment and FMEA for quality risk management (Element 2.2)
• Audit Management for internal audits and self-inspections (Element 2.5)
• CAPA and Change Control for systematic improvement (Elements 13-14)
• Training Management for personnel qualification (Element 3)
• Equipment and Calibration Management for facility controls (Elements 4-5)
• Supplier Management for contract manufacturer oversight (Elements 16-17)
• Complaint and Recall Management for post-market surveillance (Element 15)

QT9's automated workflows, audit trails, and real-time dashboards streamline inspection readiness and reduce compliance burden while improving operational efficiency.

PIC/S compliance is essential for pharmaceutical manufacturers seeking global market access and regulatory approval. Key benefits include:

• Market Access: Required for exporting to 56+ member countries including the EU, UK, Australia, Canada, and Singapore
• Regulatory Harmonization: Single compliance framework reduces duplicate inspections across multiple jurisdictions
• Inspection Mutual Recognition: PIC/S members recognize each other's GMP inspections, streamlining regulatory processes
• Quality Assurance: Standardized quality systems reduce product recalls and compliance violations
• Competitive Advantage: Demonstrates commitment to international quality standards and builds customer confidence
• Reduced Costs: Harmonized standards eliminate redundant compliance efforts across different markets

Non-compliance can result in warning letters, import bans, product recalls, and loss of market authorization.

No, PIC/S is not a certification—it's a cooperative framework that harmonizes GMP inspection standards among member regulatory authorities. PIC/S does not issue certifications or approvals. Instead, individual member authorities (like the FDA, EMA, or Health Canada) conduct GMP inspections based on PIC/S guidelines and issue their own GMP certificates or approvals.

However, PIC/S membership means regulatory authorities use harmonized GMP standards based on WHO and ICH Q10 guidelines. This allows manufacturers to demonstrate compliance once and have it recognized across multiple jurisdictions, rather than meeting different GMP requirements for each country.

Preparing for a PIC/S inspection requires systematic documentation, process validation, and readiness across all quality system elements:

Pre-Inspection Steps:

• Conduct internal audits and self-inspections to identify gaps
• Ensure all SOPs are current, approved, and accessible
• Verify training records are complete and up-to-date
• Review CAPA effectiveness and closure documentation
• Validate equipment calibration and maintenance records
• Prepare product quality reviews and management reviews
• Organize batch records, deviation reports, and change controls

During Inspection:

• Designate knowledgeable personnel to accompany inspectors
• Provide requested documents promptly and accurately
• Be transparent about any identified issues and corrective actions
• Document all inspector observations and requests

QT9 QMS Support: QT9's inspection readiness dashboards provide real-time visibility into compliance status across all PIC/S elements, helping you identify and address gaps before inspections occur.

While PIC/S and FDA both enforce GMP standards, there are key differences:

Scope:

• PIC/S: International cooperation framework covering 56+ member countries
• FDA: U.S. regulatory authority governing the American market

Standards:

• PIC/S: Based on WHO GMP guidelines and ICH Q10, harmonized across member countries
• FDA: Based on 21 CFR Parts 210/211 and ICH Q10, specific to U.S. requirements

Relationship:

• The FDA is not a PIC/S member but maintains its own GMP standards
• PIC/S guidelines align closely with FDA requirements, with minor procedural differences
• Many pharmaceutical manufacturers must comply with both PIC/S (for international markets) and FDA (for U.S. market access)

Mutual Recognition:

• PIC/S members recognize each other's inspections
• FDA conducts independent inspections regardless of PIC/S status

QT9 QMS supports compliance with both PIC/S and FDA requirements, providing a unified quality management platform for global pharmaceutical operations.