Quality Management

Commitment To Quality Excellence

At Bluegum Pharmaceuticals, we are dedicated to upholding the highest standards of quality and safety in every product we manufacture for our customers. As a licenced manufacturer by the Therapeutic Goods Administration (TGA), we adhere to the highest standards of manufacturing excellence and regulatory compliance.

Our commitment to quality is unwavering. We maintain strict quality assurance processes that conform to the requirements of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Code of Good Manufacturing Practice (GMP) for Medicinal Products. Our state-of-the-art facility is designed to ensure that every product we manufacture meets the stringent criteria set forth by the TGA.

VaIn alignment with the PIC/S Guide to GMP, we have a superior Quality Management System (QMS), which reflects the specific design elements and requirements for a quality system used in the manufacture of medicinal products. Our QMS is integral to our operations, ensuring that all aspects of our manufacturing process, from raw material selection to final product distribution, are controlled and meet the quality standards.

We take an active role in upholding our quality management principles. We ensure that our Quality team is well-trained and equipped to carry out their duties effectively, with a clear understanding of the importance of GMP and quality management.
Bluegum believes in continuous improvement. We regularly conduct Product Quality Reviews (PQRs) and engage in quality risk management to identify areas for enhancement. Our change management protocols ensure that any modifications to our processes are thoroughly evaluated and implemented without compromising product quality.

When you choose Bluegum, you can be confident that you are receiving products manufactured under a robust quality management system that prioritizes your health and safety.

Stability Program

As per TGA requirements, Stability Programs are essential, and work to ensures that all products remain safe and effective throughout their shelf life. This is done by assessing the products performance under various environmental conditions throughout the shelf lifetime by conducting ongoing testings.

Bluegum offers Stability Program Services to suit your products per the TGA Requirements, giving you the insight & data on your products performance. Knowledge will be power in ensuring your product stays effective & competitive in the market.