This guide helps you learn good manufacturing practices in australia and download the exact TGA/PIC/S PDFs you need. It points you to official TGA PDFs. From 1 September 2025, TGA applies PIC/S PE009-17 to medicines, APIs, and sunscreens, split into two parts and 20 annexes.
Good Manufacturing Practices (GMP) protect patients and your licence: WHO estimates 1 in 10 medicines in low- and middle-income countries is substandard or falsified. Use the PDF pack: PIC/S PE009-17, GMP clearance, inspection reliance, code tables, and the submission user guide, then file them in your QMS for audit-ready decisions.
Table of Contents
What are GMP standards used in Australia ?
Australia uses Therapeutic Goods Administration guidance and the PIC/S Guide to GMP. You should start with 1 core GMP standard for medicines and APIs. TGA uses these standards for inspections, licensing, and ongoing compliance checks.
Therefore, manufacturers align quality systems, validation, and records with PIC/S expectations. Download these official guides from TGA and PIC/S. Keep these PDFs in your QMS folder, then train teams regularly.
PIC/S Guide to GMP for medicinal products and APIs.
TGA GMP clearance guidance for overseas manufacturing sites.
TGA submission user guide for GMP clearance applications.
PIC/S Guide to GMP (PE009-17): what it covers and who needs it
PIC/S Guide to GMP (PE009-17) is TGA’s main GMP reference. It covers quality systems, documentation, validation, contamination control, and auditing basics. It also includes annexes for sterile manufacture, computerized systems, and qualification activities.
Therefore, manufacturers, sponsors, and QA teams use it for inspection readiness. Download 1 pack and align SOPs, training, and records to it.
- Part I (medicines): when to download it
- Part II (APIs): when it applies
- Annexes (e.g., sterile/Annex 1)
| Need | Document |
|---|---|
|
Confirm AU applicability/version |
|
|
Finished medicines GMP |
|
|
API GMP |
|
|
Sterile/CSV/Qualification topics |
|
|
Context and scope overview |
GMP Australia (TGA): PE009-17 Part I for Medicines
Download PIC/S PE009-17 Part I when you market or manufacture medicines in Australia. Therefore, use it to align your QMS, batch records, and audits with TGA expectations.
Finished-dose manufacturing sites and packers
Batch release, deviation, and CAPA decisions
Supplier qualification for excipients and components
Inspection readiness and internal audit checklists
GMP Australia (TGA): PE009-17 Part II for APIs
Use GMP Australia (TGA) PE009-17 Part II when you make APIs. It also fits when you audit API suppliers for your products.
Therefore, use it to set quality agreements and risk controls.
Approve API suppliers and contractors
Define API testing and release requirements
Control changes, deviations, and CAPA
Prepare audit checklists for inspections
GMP Australia (TGA): PE009-17 Annexes
Use GMP Australia (TGA) PE009-17 Annexes for high-risk GMP topics. They guide sterile manufacture, computerized systems, and qualification work.
Therefore, download Annexes when teams need detailed controls for audits.
Annex 1: sterile contamination control strategy
Annex 11: CSV and data integrity expectations
Annex 15: qualification and validation lifecycle
Other annexes: sampling, utilities, and outsourced activities
TGA GMP clearance (for overseas manufacturing sites)
Use TGA GMP clearance PDFs when you use an overseas manufacturing site. These guides explain pathways, evidence, and timelines. Download them early to avoid rework and delays.
Therefore, build a clearance folder before you submit in TGA Business Services. You match site scope, steps, and certificates across documents. You keep PDFs in your QMS for audits.
GMP clearance guidance: choose the right pathway and required evidence
Inspection reliance guide: use trusted inspection reports to support clearance
Code tables + user guide: pick scope codes and submit correctly
TGA submission user guide (TGA Business Services)
Use the TGA submission user guide in TGA Business Services for GMP clearance. It shows each portal step, field, and required attachment. Download it before you start, then follow it page by page.
Therefore, you reduce errors and speed up reviews. You align your site details with certificates and scope codes. You also prepare evidence in a single folder.
Application & submission user guide
Use the Application & submission user guide to file GMP clearance in TGA Business Services. It shows each screen, required fields, and upload steps. Download it first, then follow the flow without guessing.
Therefore, you cut rework and speed up approval. You also keep your evidence consistent across every attachment. Use these quick checks before you click submit.
Confirm legal entity, site name, and site address match certificates
Select manufacturing steps using the TGA code tables guidance
Upload current GMP evidence and supporting inspection documents
Use clear file names and keep one folder for all PDFs
Review every field, then submit with the right contact email
Pre-submission checklist to avoid delays (common missing items)
Use a pre-submission checklist before you lodge GMP clearance in TGA Business Services. It helps you prevent delays and repeated requests. It also keeps your evidence aligned across every file.
Therefore, build one folder and verify details once. Check names, addresses, and scopes line by line. Confirm dates and versions before you upload.
Then run these final checks and submit with confidence.
| Check area | What to verify | Owner |
|---|---|---|
|
Applicant details |
Legal entity name matches supporting documents |
RA / Sponsor |
|
Site identity |
Site name and full address match across all files |
QA / RA |
|
Manufacturing scope |
Manufacturing steps align with your actual operations |
QA |
|
Code selection |
Correct scope codes selected using code tables guidance |
RA |
Final words
This page summarizes good manufacturing practices in australia and links official TGA/PIC/S PDFs. From 1 September 2025, TGA applies PIC/S PE009-17 Version 17 to medicines, APIs, and sunscreens. The Guide has 2 parts and 20 annexes, so you can map requirements quickly.
Good Manufacturing Practices (GMP) support audit readiness and patient protection. TGA notes a 6-month transition for some Annex 1 changes. Download the PDF pack: PE009-17, GMP clearance, inspection reliance, code tables, and the submission user guide. Use these PDFs to build SOPs, training, and evidence files pre-submission. Explore GMP Courses for structured practice.
FAQs:
TGA aligns medicine GMP expectations with the PIC/S Guide to GMP. You should use PE009-17 as your core reference pack.
Inspection reliance lets you support clearance using trusted inspection evidence. You still must match scope, site details, and manufacturing steps.
Start with PIC/S PE009-17 Part I if you handle finished medicines. Add Annexes next if you work with sterile, CSV, or validation.
References
Ershad Moradi, a Content Marketing Specialist at Zamann Pharma Support, brings 6 years of experience in the pharmaceutical industry. Specializing in pharmaceutical and medical technologies, Ershad is currently focused on expanding his knowledge in marketing and improving communication in the field. Outside of work, Ershad enjoys reading and attending industry related networks to stay up-to-date on the latest advancements. With a passion for continuous learning and growth, Ershad is always looking for new opportunities to enhance his skills and contribute to pharmaceutical industry. Connect with Ershad on Facebook for more information.
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