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Facility design and GMP requirementsDesign for dose forms and routes Good hygiene and sanitationPreventing contamination Management responsibilitiesLeadership and quality culture Investigations, deviations and CAPAEffective failure investigation Complaints, quality defects and recallsTimely, compliant handling Cleaning validationPreventing cross-contamination Production operator certificationProcess control on the floor Pest control managementFacility protection Documentation and recordsTraceability and accountability Supplier assuranceSupply-chain quality Good quality control laboratory practiceReliable QC results Validation and qualificationProcess and equipment Pharmaceutical quality systems and ICH Q10PQS fundamentals Quality risk managementICH Q9 tools and practice Self-inspectionsFinding gaps before inspectors do Change managementControlled, compliant change

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Home About Consulting Auditing

GMP Training

All gmp training Facility design and GMP requirements Good hygiene and sanitation Management responsibilities Investigations, deviations and CAPA Complaints, quality defects and recalls Cleaning validation Production operator certification Pest control management Documentation and records Supplier assurance Good quality control laboratory practice Validation and qualification Pharmaceutical quality systems and ICH Q10 Quality risk management Self-inspections Change management

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All services Project management Facility design and validation Regulatory inspection preparedness Process review and improvement Operational excellence Facility and system audits Supplier auditing and qualification Due diligence Quality Management System solutions Quality Risk Management On-site training, including new hires

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Regulatory Updates

Regulatory Updates

Changes to GMP and GDP guidance from regulators and international bodies.

Regulatory Updates · 9 Sep 2023

Regulatory Update

New PIC/S documents for GDP inspectors came into force on 1 February 2023, and the MHRA published the 5th edition of its Green Guide for pharmaceutical distributors.

Quality, compliance and GMP advisory for pharmaceutical, biopharmaceutical and medical-device manufacturers.

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