Scope
This training program defines the complete knowledge and performance requirements for personnel involved in pharmaceutical manufacturing to become certified auditors for Good Manufacturing Practice (GMP) in the European Union regulatory environment. The program integrates EU GMP requirements from EudraLex Volume 4 (Part I: Basic Requirements for Medicinal Products, Part II: Basic Requirements for Active Substances, and relevant Annexes) with auditing practices based on ISO 19011:2026 for internal, second-party (vendor, CRO, and supplier) audits and global regulatory compliance auditing.
The participant learns what EU GMP requires across all aspects of pharmaceutical manufacturing, how to audit those requirements, and how to conduct audits across multiple jurisdictions and organizational boundaries. ISO 19011:2026 provides the methodological framework for planning, conducting, reporting, and following up on audits. The standard covers audit principles, audit programme management, the conduct of management system audits, and the evaluation of auditor competence. It is applicable to all organizations that need to plan and conduct internal or external audits of management systems.
Regulatory Frameworks Covered
- EU GMP Guide (EudraLex Volume 4, Part I) establishes the Basic Requirements for Medicinal Products, covering the Pharmaceutical Quality System, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced Activities, Complaints and Recalls, and Self-Inspection.
- EU GMP Guide (EudraLex Volume 4, Part II) covers Basic Requirements for Active Substances used as Starting Materials, based on ICH Q7 guidelines, and addresses manufacturing processes from raw materials through to finished active substances.
- EU GMP Annex 1 provides detailed requirements for the Manufacture of Sterile Medicinal Products with its Contamination Control Strategy , cleanroom grades , barrier technologies , sterilization methods , aseptic processing , environmental monitoring , and personnel gowning.
- EU GMP Annex 2 covers the Manufacture of Biological Active Substances and Medicinal Products including cell banks , seed lots , viral safety , multi-product facilities , and specific product types such as vaccines , monoclonal antibodies , and gene therapy products.
- EU GMP Annex 3 addresses the Manufacture of Radiopharmaceuticals covering radiation protection , short shelf-life considerations , hot-cells , two-stage release , and personnel dosimetry.
- EU GMP Annex 7 covers the Manufacture of Herbal Medicinal Products including Good Agricultural and Collection Practice , supplier qualification , contaminant testing , and specific quality control requirements for botanical materials.
- ISO 19011:2026 provides the Guidelines for auditing management systems , covering audit principles , audit programme management , conducting audits , remote auditing methods , and competence evaluation. The 2026 edition embeds remote and hybrid auditing throughout the full audit lifecycle.
Auditing Practices Covered (ISO 19011:2026)
- Seven principles of auditing: integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach
- Audit programme management: objectives, risks, opportunities, resources, procedures, implementation, monitoring, review, and improvement
- Conduct of an audit: initiation, preparation, execution, reporting, and follow-up
- Remote and hybrid auditing methods: virtual audits, technology considerations, security, and contingency planning
- Competence and evaluation of auditors: personal behaviour, knowledge and skills, evaluation methods, and maintaining competence
- Second-party auditing: supplier qualification, vendor audits, and service provider oversight
Operational Areas Covered
- Pharmaceutical Quality System and Quality Risk Management
- Personnel qualifications, training, hygiene, and gowning requirements
- Premises design, cleanroom classifications (Grades A through D), and barrier technologies including isolators and RABS
- Equipment qualification , including design qualification , installation qualification , operational qualification , and performance qualification , and maintenance requirements
- Documentation systems and Good Documentation Practices
- Production operations and cross-contamination prevention, including campaign manufacturing and cleaning validation
- Process validation, cleaning validation, and revalidation requirements
- Quality Control laboratory operations and stability testing
- Sterile product manufacturing including aseptic processing
- Biological product manufacturing including viral clearance
- Radiopharmaceutical manufacturing including radiation safety
- Herbal medicinal product manufacturing including contaminant testing
- Complaints, recalls, and self-inspection
- Supplier qualification and supply chain auditing
The program is designed for global auditing across internal, second-party, and regulatory readiness contexts and does not qualify individuals to conduct regulatory inspections on behalf of authorities.
Objectives
Upon completion of this program, the participant will be able to:
- Interpret and apply EU GMP requirements from Part I, Part II, and Annexes 1, 2, 3, and 7 to pharmaceutical manufacturing operations
- Understand and apply the seven auditing principles (integrity, fair presentation, due professional care, confidentiality, independence, evidence-based approach, and risk-based approach)
- Plan, manage, and execute internal, second-party, and global audits in full accordance with ISO 19011:2026
- Conduct supplier and vendor audits to assess compliance with EU GMP and contractual requirements
- Conduct facility audits to assess premises, equipment, and utility systems for GMP compliance
- Develop audit checklists, sampling plans, and audit protocols tailored to pharmaceutical risks and regulatory requirements
- Collect objective evidence through on-site and remote interviews, observation, and document review
- Identify and classify non-conformities (critical, major, and minor) with clear justification referencing specific regulatory requirements
- Write non-conformity reports that are factual, complete, and actionable
- Prepare and distribute audit reports to appropriate management levels and stakeholders
- Notify management of critical findings using escalation procedures
- Track corrective and preventive actions using a formal tracking log with status codes
- Verify effectiveness of corrective and preventive actions
- Close an audit properly with a closure memo and management acknowledgment
- Contribute audit results to management review and continual improvement
- Prepare organizations for regulatory inspections and respond to inspection findings
Target Audience
This program is specifically designed for personnel involved in the manufacture, oversight, or auditing of pharmaceutical products in accordance with EU GMP requirements. Typical roles include:
- Quality Assurance Personnel – responsible for independent monitoring of pharmaceutical manufacturing, conducting internal and vendor audits, and assuring GMP compliance across multiple regulatory frameworks
- Quality Control Personnel – responsible for laboratory operations, analytical testing, and stability programs; need to understand auditing principles and GMP requirements for QC laboratories
- Production and Manufacturing Staff – responsible for manufacturing operations; need to understand how their processes will be audited and how to maintain GMP compliance
- Qualified Persons – responsible for batch certification and release; need to understand auditing principles and how quality systems are assessed
- Engineering and Maintenance Personnel – responsible for equipment qualification, utilities, and facility maintenance; need to understand GMP requirements for premises and equipment
- Warehouse and Logistics Staff – responsible for materials handling, storage, and distribution; need to understand GMP requirements for warehouse operations
- Regulatory Affairs Professionals – responsible for regulatory submissions and compliance; need to understand GMP requirements and auditing principles
- Supplier Qualification Professionals – responsible for supplier selection, qualification, and monitoring; need to understand auditing principles and supply chain GMP requirements
- Contract Manufacturing Organization Personnel – service providers conducting manufacturing activities on behalf of sponsors; need to understand auditing requirements
- Microbiology and Sterility Assurance Personnel – responsible for environmental monitoring, sterility testing, and contamination control; need to understand auditing principles for sterile products
- Validation Personnel – responsible for process validation, cleaning validation, and equipment qualification; need to understand auditing requirements for validation activities
- Audit Program Managers – responsible for planning, managing, and overseeing audit programmes across multiple regions and vendors
- Regulatory Compliance Officers – responsible for ensuring organizational compliance with global GMP regulations
Certification Requirements
To obtain the EU GMP Auditor Certification designation, the participant must complete the following steps:
- Complete all modules in sequence.
- Achieve a minimum score of 80 percent (8 out of 10 questions) on each module quiz.
Certificate of Completion
Upon successful completion of all module assessments and the final examination, you will receive a Certificate of Completion for the EU GMP Auditor Certification.
Certificate Details:
- Participant’s full name and designation
- Training program title and date of completion
- Authorized signatory and issuing organization details
- Unique certificate number for verification purposes
