Australia Pharmacy GMP Compliance Checklist (TGA)
This GMP compliance checklist aligns with the Therapeutic Goods Administration (TGA) requirements under the Therapeutic Goods Act 1989, PIC/S Guide to Good Manufacturing Practice for Medicinal Products, and relevant Australian Standards. Pharmacies compounding sterile and non-sterile preparations must meet these requirements. Complete this audit as part of regular compliance monitoring.
- Industry: Healthcare
- Frequency: Monthly
- Estimated Time: 35-45 minutes
- Role: Pharmacist-in-Charge / Quality Assurance Officer
- Total Items: 29
- Compliance: TGA PIC/S GMP Guide, Therapeutic Goods Act 1989, Pharmacy Board of Australia Guidelines, AS/NZS ISO 9001, USP <797> (sterile compounding)
Premises & Facilities
GMP premises requirements per PIC/S Guide Chapter 3.
- Premises clean and well-maintained?
- Temperature monitoring systems operational (15-25 degrees C)?
- Cold chain storage (2-8 degrees C) monitored and logged?
- Pest control program in place?
- Adequate segregation of dispensing, compounding, and storage areas?
Equipment & Calibration
Equipment qualification and calibration per GMP requirements.
- Equipment qualification (IQ/OQ/PQ) documentation current?
- Calibration of measuring instruments current?
- Daily balance checks performed and recorded?
- Equipment cleaning validated and documented?
- Preventive maintenance schedule followed?
Documentation & Records
GMP documentation requirements per PIC/S Guide Chapter 4.
- Batch records complete and accurate?
- Standard Operating Procedures current and accessible?
- Deviations documented and investigated?
- Change control procedures followed?
- Records retained for required period?
Production & Compounding
Manufacturing and compounding process controls.
- Master formulation records available and followed?
- Raw materials tested and released before use?
- In-process checks performed and documented?
- Labels accurate and compliant with TGA requirements?
- Cross-contamination prevention measures effective?
Quality Control & Testing
Quality control testing and release procedures.
- Quality control testing performed per specifications?
- Stability testing program in place?
- Out-of-specification results investigated?
- Product recall procedure documented and tested?
Controlled Substances & Schedule 8
Management of controlled substances per state/territory legislation.
- Schedule 8 (S8) register maintained accurately?
- S8 stock balances reconciled regularly?
- Controlled substances stored in approved safe/vault?
- Discrepancies investigated and reported?
- Additional observations and actions required
Related Healthcare Checklists
- Australia Medical Device Audit Checklist (TGA)
- Australia Pathology Lab Safety Checklist (NPAAC)
- Australia Blood Bank Compliance Checklist (TGA)
- Australia Veterinary Practice Safety Audit Checklist
- Australia Dental Practice Safety Checklist (ADA Guidelines)
- Australia Mental Health Facility Inspection Checklist
- Australia Ambulance Vehicle Pre-Trip Check
- Australia Radiology Safety & Compliance Checklist
Related Clinical Compliance Checklists
- Joint Commission Readiness - FREE Download
- HIPAA Compliance Audit - FREE Download
- OSHA Healthcare Compliance - FREE Download
- Surgical Instrument Sterility - FREE Download
- Blood Bank Quality Control - FREE Download
- Radiology Equipment QA - FREE Download
- Endoscope Reprocessing - FREE Download
- Central Line Bundle Checklist - FREE Download
- Ventilator Bundle Checklist - FREE Download
- Catheter Associated UTI Bundle - FREE Download
Why Use This Australia Pharmacy GMP Compliance Checklist (TGA)?
This australia pharmacy gmp compliance checklist (tga) helps healthcare teams maintain compliance and operational excellence. Designed for pharmacist-in-charge / quality assurance officer professionals, this checklist covers 29 critical inspection points across 6 sections. Recommended frequency: monthly.
Ensures compliance with TGA PIC/S GMP Guide, Therapeutic Goods Act 1989, Pharmacy Board of Australia Guidelines, AS/NZS ISO 9001, USP <797> (sterile compounding). Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What is a Australia Pharmacy GMP Compliance Checklist (TGA)?
A Australia Pharmacy GMP Compliance Checklist (TGA) is a standardized inspection form used by pharmacist-in-charge / quality assurance officer to ensure consistent healthcare operations. It contains 35 inspection points organized into 6 sections. FREE PDF download - Australian pharmacy GMP compliance checklist aligned with TGA PIC/S Guide to Good Manufacturing Practice. Covers premises, equipment, documentation, production, quality control, and self-inspection requirements. Download FREE template now.
How often should I use this healthcare checklist?
This checklist is designed to be completed monthly. Regular use ensures compliance with TGA PIC/S GMP Guide and Therapeutic Goods Act 1989 and helps identify issues before they become problems.
Can I download this Australia Pharmacy GMP Compliance Checklist (TGA) as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 35 fields across 6 sections and typically takes 35-45 minutes to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with TGA PIC/S GMP Guide, Therapeutic Goods Act 1989, Pharmacy Board of Australia Guidelines, AS/NZS ISO 9001, USP <797> (sterile compounding). Following these standards protects your organization and ensures best practices.
How do I complete this healthcare inspection checklist?
Begin by completing the header fields for Pharmacy Name, TGA Licence Number, Inspection Date, Inspector Name, State/Territory, and Pharmacy Type. Work through each of the 6 sections, marking items Yes or No as applicable. Add notes for any issues found. The entire process takes approximately 35 to 45 minutes.
What are the key sections in this healthcare checklist?
This healthcare checklist is organized into 6 key sections: Premises & Facilities, Equipment & Calibration, Documentation & Records, Production & Compounding, Quality Control & Testing, Controlled Substances & Schedule 8. Each section contains specific inspection points that pharmacist-in-charge / quality assurance officer must verify. The structured layout ensures nothing is missed during healthcare inspections and makes the process efficient, typically taking 35-45 minutes to complete.
Who should use this Australia Pharmacy GMP Compliance Checklist (TGA)?
This checklist is primarily designed for pharmacist-in-charge / quality assurance officer working in healthcare operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that healthcare standards are being met. Organizations of all sizes can benefit from using this Australia Pharmacy GMP Compliance Checklist (TGA) to maintain consistency and accountability.