An in-person course covering the design, construction, validation and operation of a GMP facility

Course Outline:

Applying for an Inspection

Introduction to TGA GMP Compliance – Importance of compliance
GMP Inspection Application Process – Application timeline, documentation, and scheduling
Scope of Inspection and Process Mapping – Identifying product types and manufacturing steps
Regulations and GMP Standards Overview – Familiarity with PIC/S Guide, TGOs, and exemptions

Getting Ready for an Inspection

“Hardware” (or physical plant and equipment)

Building Production and laboratories – Site selection, greenfield or brownfield, clean rooms/laboratories
Utilities: HVAC, Water Systems, and Compressed Air/Gases – Utility systems description, controls, monitoring, and data management
Validation Program and Study Protocols – Validating processes, equipment, and analytical methods; report analysis

“Software” (or people and paper)

Quality System Management – Handling deviations, risk assessment, CAPA, and rework processes
Documentation System Management – Managing production, storage, cleaning, and in-process checks documentation
Engineering: Maintenance and Calibration – Equipment traceability, maintenance, and calibration documentation
Batch Documentation and RFS Compliance – Documenting manufacturing steps, cleaning, and checks for TGO compliance
Quality Control: Chemistry and Microbiology Testing – Sampling, testing methods, instruments, and data integrity
Inspection Preparation: Personnel and Training – Personnel qualifications, hygiene, and training effectiveness measures
Product Quality Review and Improvement Recommendations – Data analytics, incident assessments, and recommendations for improvement
Conclusion and Next Steps for TGA GMP Compliance – Summarizing the workshop and preparing for inspection and ongoing compliance

Note: Registrations will only be accepted for industry personnel. We kindly request that consultants do not register for this workshop. PharmOut reserves the right to cancel registrations from consultants.