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Under Australian law, suppliers of therapeutic goods must maintain thorough documentation of product quality. Quality extends beyond manufacturing controls to include labelling, traceability and product information. Therefore, the TGA expects suppliers to actively manage these areas to ensure compliance and patient safety.

Labelling Responsibilities

Quality labels prevent confusion and ensure safe use. The Therapeutic Goods (Labelling) Orders (TGO 91/92) set mandatory labelling requirements. As a supplier, you must ensure every product label follows those rules. For example, include the medicine name, active ingredients, batch number, expiry date and storage conditions. Always show the sponsor’s (or distributor’s) name and address.

  • Use accurate claims: Do not make unsupported statements. For example, if the label says “sugar-free”, confirm with your ingredient supplier that no sugar is present.

  • Meet legal requirements: Ensure your labels comply with all aspects of the Therapeutic Goods Labelling Order. This includes mandatory advisory statements, ingredient lists, dosage instructions and warning labels.

  • Maintain artwork control: Provide and use controlled label artwork. Approve all designs to avoid printing mistakes. Check that fonts, graphics and symbols meet TGA guidance (e.g. legible lettering for critical health information).

Each time you print labels, do a final check. For instance, confirm that batch and expiry numbers are correctly placed and formatted. If a product is intended “For practitioner dispensing only”, ensure you meet the specific labelling conditions in TGO 92 (e.g. including the phrase “For Practitioner Dispensing Only” if applicable). By carefully reviewing labels against regulations, you prevent regulatory breaches and help protect consumers.

Traceability Responsibilities

Traceability means you can track each product batch through the supply chain. This is vital for quality control and recalls. You must record key production identifiers (batch/lot numbers, serial numbers, expiry dates) for every shipment. The TGA explicitly requires sponsors to keep records of these identifiers. This ensures that if a product recall or safety action is needed, you can quickly identify affected batches.

  • Record distribution: Maintain detailed logs of where each batch is sent. For example, record customer names, dates, and quantities supplied.

  • Track returns and complaints: Document any returns, quality complaints or adverse event reports and link them to specific batch numbers.

  • Use labelling for traceability: Ensure each unit has a clear lot or batch code. If you use barcodes or QR codes, verify that they scan correctly to the right batch information.

  • Retain records: Keep distribution and production records for the required period. (For example, many records must be kept for several years under TGA guidelines.)

By organising product data and shipment records, you can isolate issues swiftly and address them before they escalate. Traceability builds trust in your supply chain and supports compliance with the TGA’s market action procedures.

Product Information Responsibilities

Product information

Accurate product information is part of quality. This includes the technical documents you keep internally and the information you provide to end users. Suppliers must ensure that all product information is up to date, clear and compliant. For instance, if new safety or usage information arises, update your documents promptly. The TGA requires sponsors to update product labels and information leaflets with new safety data in a timely way.

  • Update labels and leaflets: If new hazards or instructions emerge, revise your labels and consumer information (CMI) or product information (PI) leaflets without delay.

  • Provide complete details: Ensure Consumer Medicines Information and Package Inserts include accurate dosage, side-effects and allergy warnings. Supply these with every batch when required.

  • Maintain documentation: Keep internal product dossiers, including specifications and certificates of analysis, current. Document testing results, stability data and supplier qualifications.

  • Ensure clear communication: Train your team on any product info changes. For example, if a storage condition changes, update your packing instructions and inform all distributors.

Good product information also means avoiding promotional claims on labels or literature unless specifically approved. Always stick to approved indications and language. By actively managing product information, you support compliance and help healthcare professionals and patients use the products safely.

Staying Compliant

Overall, the TGA’s quality framework holds suppliers accountable for more than just GMP. You must implement a quality system that covers labelling accuracy, supply-chain traceability and information management. Firstly, establish clear processes and checklists for labelling each product. Next, use inventory and ERP systems to log batch data at every step. Additionally, schedule regular reviews of your product information against the latest regulations.

By following these steps, you build a strong quality culture. Remember, keeping product labelling correct and complete, tracking every batch, and maintaining up-to-date product information are all as crucial as manufacturing quality. This comprehensive approach meets TGA requirements, helps avoid regulatory issues and ultimately protects patient health.

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