Regulatory Compliance

Regulatory Compliance

Regulatory Compliance

Bluegum Pharmaceuticals is committed to adhering to all regulatory requirements set forth by the Therapeutic Goods Administration (TGA) for the manufacturing and distribution of complementary medicines. Our dedication to compliance ensures that our products meet the highest standards of safety, quality, and efficacy, providing consumers with confidence in the therapeutic value of our offerings. Bluegum Pharmaceuticals is approved to manufacture listed medicines (AUST L) and food grade products.

Regulatory Compliance 2
Regular Compliance 2

Manufacturing Practices

  • Bluegum Pharmaceuticals  operates in accordance with the principles of Good Manufacturing Practice (GMP) as outlined by the TGA. Our manufacturing facilities are regularly inspected to ensure compliance with all applicable regulations.
  • We maintain comprehensive documentation of our manufacturing processes, including batch records, standard operating procedures (SOPs), and quality control measures to guarantee consistency and traceability.

Product Registration and Listing

  • Bluegum Pharmaceuticals provides product specifications, allergen statements, stability studies and shelf-life determination to ensure compliance for Listed Medicines (AUST L). Also we offer support with domestic and international registration.
  • Prior to market entry, all of the complementary medicines we manufacture undergo rigorous assessment and registration with the TGA.

Labeling

  • We provide support on product labelling to ensure that it adheres to TGA guidelines, and that it provides accurate and comprehensive information to consumers regarding indications, dosage, ingredients, and precautions. 
  • We can support with Trademark License Approvals for branded ingredients, giving your product the advantage of having trusted trademarks visible to consumers on your packaging 

Quality Management System

  • Our Quality Management System (QMS) encompasses all aspects of manufacturing, distribution, and post-market surveillance to ensure ongoing compliance with TGA regulations.
  • We regularly review and update our QMS procedures to incorporate changes in regulatory requirements, industry best practices, and emerging scientific evidence.

Compliance Training

  • Bluegum Pharmaceuticals  provides comprehensive training to all employees involved in the manufacturing, distribution, and promotion of complementary medicines to ensure awareness and understanding of regulatory requirements.