Applies to: All Newcastle Cosmetic Doctor (NCD) clinical, procurement, and administrative staff

1. Purpose

To set out the quality control (QC), batch verification, and supplier compliance requirements for all topical products used, supplied, or recommended by Newcastle Cosmetic Doctor (NCD), including prescription compounds and retail cosmeceuticals. This SOP ensures that products are sourced from compliant manufacturers and pharmacies, verified on receipt, traceable by batch and expiry, and recall-ready—meeting Australian regulatory and accreditation standards while benchmarking to international GMP/GDP frameworks. ^{1 2 3 4}

2. Scope & Applicability

Applies to procurement, clinical, and administrative processes covering supplier selection, approval, monitoring, incoming goods checks, quarantine and release, documentation, and recall management for topical products. Includes compounded medicines prepared by external pharmacies and retail skincare lines carried by NCD. Excludes schedule storage and cold-chain specifics (covered in the Medication Storage, Cold Chain & Controlled Substances SOP). ^{5 6 7}

3. Legislative & Regulatory Framework

NCD operates within the Therapeutic Goods Act/TGA framework for therapeutic goods, NSW Poisons and Therapeutic Goods requirements for storage and access, and NSQHS Standards for clinical governance and medication safety. Cosmetic products must comply with AICIS chemical introductions and ACCC labelling/recall obligations, while compounded items follow Pharmacy Board compounding guidelines and professional standards. Where relevant, international benchmarks (PIC/S GMP, WHO GDP, ISO 22716, EU 1223/2009, FDA cosmetic GMP) inform supplier vetting and QC expectations. ^{1 8 4 9 9 7 12 13 8 10 11}

4. Definitions

“Approved Supplier” means a manufacturer, sponsor, distributor, or pharmacy assessed by NCD and accepted onto the Approved Supplier List (ASL) based on objective evidence of compliance. “Batch Verification” refers to the process of confirming that received product lots match purchase specifications and comply with documented quality attributes (identity, strength, appearance, expiry). “Certificate of Analysis (CoA)” is a supplier-issued document demonstrating conformity of a batch to predefined specifications; for compounded preparations, equivalent batch documentation is required from the compounding pharmacy. ^{1 7 12}

5. Supplier Vetting & Approval

Suppliers are vetted prior to first purchase using a structured questionnaire and evidence pack. Acceptable evidence includes GMP certification or licence (TGA/PIC/S), ISO 22716 conformance for cosmetics, AICIS registrations for cosmetic ingredients, and professional accreditation for compounding pharmacies. NCD reviews complaint history, recall history, and regulatory actions, and performs risk-based approval with periodic revalidation at least every 24 months. ^{1 12 8 9 7}

6. Approved Supplier List (ASL) Management

NCD maintains an ASL capturing supplier identity, scope of supply, regulatory certificates, last audit/review date, and risk rating. Changes in ownership, manufacturing site, certification status, or significant quality incidents trigger immediate reassessment. Suppliers not meeting minimum compliance standards are suspended until corrective actions are verified. ^{4 12 13}

7. Purchase Specifications & Quality Agreements

Each product has documented specifications (name, concentration, packaging, storage, minimum remaining shelf-life on delivery, labelling language, and evidence requirements). Where appropriate, NCD establishes a quality agreement outlining responsibilities for notification of change, CoA provision, transport conditions, deviation reporting, and recall participation. Compounding pharmacies provide formulation records, beyond-use dating, and batch records for each compounded lot. ^{1 7 12 13}

8. Incoming Goods Inspection & Quarantine

Upon receipt, shipments are inspected for integrity, item/strength match, quantity, batch/lot, expiry, and temperature indicators where applicable. Nonconforming or damaged deliveries are quarantined and labelled “Do Not Use” pending investigation. Only authorised staff may release stock after verification against purchase specifications and documentation. ^{13 1 4}

9. Batch Verification & Certificates of Analysis

For each batch received, NCD confirms batch/lot and expiry against delivery documents and reviews the CoA where provided to verify identity, assay, microbial quality (where relevant), and appearance. For compounded topical medicines, NCD requires batch documentation from the pharmacy, including formulation, beyond-use date, and any microbial/quality checks performed. Discrepancies or missing documentation trigger quarantine and supplier follow-up prior to release. ^{1 7 12 12}

10. Storage, Transport Conditions & GDP expectations

Suppliers must ensure adequate packaging and transport controls to prevent heat, light, or moisture damage and to maintain any cold-chain requirements. NCD verifies transport declarations and checks temperature indicators when applicable. Good Distribution Practices (GDP) inform expectations for handling, segregation, and traceability from supplier to clinic receiving point. ^{13 1 12}

11. Nonconformance, Deviation & CAPA

Any quality defect, mislabelling, damaged packaging, out-of-specification documentation, or adverse trend is recorded as a nonconformance. The Responsible Medical Practitioner (or delegate) assesses risk, assigns containment actions (quarantine/hold), and initiates Corrective and Preventive Actions (CAPA) with the supplier when indicated. Effectiveness of CAPA is verified at closure and considered at supplier re-approval. ^{4 1 12}

12. Traceability, Recall Readiness & Incident Response

Inventory systems maintain traceability from supplier to patient by product name, batch/lot, and expiry. NCD monitors TGA/ACCC recall notices and maintains internal recall procedures detailing identification, quarantine, patient notification, and documentation of outcomes. Post-incident review findings inform updates to specifications, supplier status, and staff training. ^{13 10 4}

13. Documentation, Privacy & Record Retention

All supplier vetting records, certificates, specifications, incoming inspection logs, quarantine/releases, CAPA, and recall files are retained for at least seven years. Records containing personal information or patient identifiers are handled under the Australian Privacy Principles and role-based access control. Electronic systems must maintain audit trails for edits and deletions. ^{14 4}

14. Training & Competency

Staff involved in procurement, receiving, and quality checks complete induction and annual refresher training on supplier compliance, batch verification, documentation standards, and recall processes. Competency is assessed by observed practice and periodic knowledge checks, with remedial training following audit findings. ^{4 1}

15. Review & Continuous Improvement

This SOP is reviewed annually or upon regulatory change, significant supplier incidents, or audit findings. NCD benchmarks against updated PIC/S, ISO 22716, WHO GDP, and TGA guidance to continuously strengthen supplier oversight and product quality assurance. ^{12 8 13 1}

Sources

1. Therapeutic Goods Administration (TGA), GMP, manufacturing licensing & therapeutic goods framework., viewed 24 October 2025, https://www.tga.gov.au ↩
2. TGA, Therapeutic Goods (Excluded Goods) Determination 2023 (cosmetic vs therapeutic boundary)., viewed 24 October 2025, https://www.tga.gov.au ↩
3. NSW Health, Pharmaceutical Services – Poisons and Therapeutic Goods (storage, records, authorities)., viewed 24 October 2025, https://www.health.nsw.gov.au/pharmaceutical/Pages/default.aspx ↩
4. ACSQHC, NSQHS Standards – Clinical Governance (Std 1) & Medication Safety (Std 4)., viewed 24 October 2025, https://www.safetyandquality.gov.au/ ↩
5. AHPRA / Medical Board of Australia, Professional responsibilities & oversight for prescribing/supply., viewed 24 October 2025, https://www.medicalboard.gov.au/ ↩
6. OAIC, Australian Privacy Principles – health privacy and record retention., viewed 24 October 2025, https://www.oaic.gov.au/privacy/your-privacy-rights/health-and-medical-research/guide-to-health-privacy ↩
7. Pharmacy Board of Australia, Guidelines on compounding of medicines., viewed 24 October 2025, https://www.pharmacyboard.gov.au/ ↩
8. Standards Australia, AS ISO 22716: Cosmetics – Good Manufacturing Practices (GMP)., viewed 24 October 2025, https://www.standards.org.au/ ↩
9. AICIS (Australian Industrial Chemicals Introduction Scheme), Cosmetic ingredient regulation & registrations., viewed 24 October 2025, https://www.industrialchemicals.gov.au/ ↩
10. ACCC, Product Safety Australia – Product recalls & consumer law obligations., viewed 24 October 2025, https://www.productsafety.gov.au/ ↩
11. TGA, Recall actions for therapeutic goods – TGA requirements., viewed 24 October 2025, https://www.tga.gov.au/resources/resource/guidance/recall-actions-therapeutic-goods ↩
12. PIC/S (Pharmaceutical Inspection Co-operation Scheme), Guide to GMP for medicinal products., viewed 24 October 2025, https://picscheme.org/en/publications ↩
13. WHO, Good Distribution Practices (GDP) and quality systems for health products., viewed 24 October 2025, https://www.who.int/publications ↩
14. European Commission, Regulation (EC) No 1223/2009 on Cosmetic Products., viewed 24 October 2025, https://health.ec.europa.eu/system/files/2021-09/2013_cosmetic_product_fiche_en_0.pdf ↩
15. FDA, Good Manufacturing Practices for cosmetics (Guidance)., viewed 24 October 2025, https://www.fda.gov/cosmetics/cosmetics-guidance-regulation/cosmetic-good-manufacturing-practices ↩
16. ICH Q7, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients., viewed 24 October 2025, https://www.ich.org/page/quality-guidelines ↩
17. RACGP, Clinical governance, risk and supplier safety considerations in general practice., viewed 24 October 2025, https://www.racgp.org.au/ ↩