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
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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 does the Australia Pharmacy GMP Compliance Checklist (TGA) cover?
This checklist covers 29 inspection items across 6 sections: Premises & Facilities, Equipment & Calibration, Documentation & Records, Production & Compounding, Quality Control & Testing, Controlled Substances & Schedule 8. It is designed for healthcare operations and compliance.
How often should this checklist be completed?
This checklist should be completed monthly. Each completion takes approximately 35-45 minutes.
Who should use this Australia Pharmacy GMP Compliance Checklist (TGA)?
This checklist is designed for Pharmacist-in-Charge / Quality Assurance Officer professionals in the healthcare industry. It can be used for self-assessments, team audits, and regulatory compliance documentation.
Can I download this checklist as a PDF?
Yes, this checklist is available as a free PDF download. You can also use it digitally in the POPProbe mobile app for real-time data capture, photo documentation, and automatic reporting.