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Product Quality and Safety

Mayne Pharma is committed to the safety of patients as they use the medications we develop, manufacture and market.

We have a solid track record of quality and safety and continuously invest in embedding a culture of quality and safety at all levels of our company. The Company is committed to delivering quality products and services which comply with all relevant regulatory and customer requirements.

Mayne Pharma aims to do this by:

  • Maintaining the right level of skill and experience within our organisation to manage and grow the quality systems with responsibilities clearly defined
  • Regular review of quality systems to ensure currency and efficiency via management review and continuous improvement strategies
  • Appropriate risk based controls over all management and GxP (good (anything eg. manufacturing) practice) including but not limited to adequate qualification of all facilities, equipment, processes, procedures, test methods and suppliers

In FY20, 43% of the products directly marketed by Mayne Pharma (by value) were manufactured at our facilities in Greenville, North Carolina and Salisbury, South Australia. The remaining products were sourced from partners around the world.

Audits are undertaken at our own locations and at third party partner facilities. We conduct due-diligence site visits or desktop audits before agreeing to partner with a third party. Choosing suppliers involves a rigorous assessment of their facilities, past track record, capacity and ability to maintain continuity of supply.

Our facilities along with our partner facilities are inspected regularly by health authorities around the world including the Food and Drug Administration (US) and the Therapeutic Goods Administration (Australia).

Mayne Pharma adheres to Good Manufacturing Practice (cGMP) in its operations related to product manufacture, along with Good Clinical Practices (GCP). Pharmacovigilance and Regulatory Affairs track compliance with health authority regulations, Mayne Pharma policies and industry standards.

During product development, the safety of products is assessed throughout each stage via either clinical studies or other equivalence testing (comparing the product in development to existing products on market), together with comprehensive stability testing. The data from these studies are submitted to the relevant regulatory agency for approval prior to launch.

From launch all products have a “Product Information” leaflet available to explain known safety issues with each product. Customer health and safety is regularly assessed through various quality reporting systems including:

  • monthly management reporting
  • quarterly quality management review
  • biannual extended safety team meetings
  • annual review and trending of product complaints

Mayne Pharma has procedures for monitoring product complaints and drug safety on marketed products and relevant employees and contractors undertake regular training. This includes literature surveillance and verbal reports which are all handled and investigated for potential causality and reported where appropriate to the relevant regulators and added to product information updates for prescribers and included in consumer medical information.

Mayne Pharma complies with the US FDA required Drug Supply Chain Security Act (DSCSA) which requires our products (both manufactured internally or sourced from third party Contract Manufacturing Organizations (CMO)) to be uniquely serialized to protect against counterfeit occurrences. We also have Verification Router Service (VRS) capability to validate any suspected counterfeit products. Upon becoming aware of counterfeit product by us or our customers we would then notify the FDA of any suspect product.

In FY20, Mayne Pharma had 29 regulatory and customer inspections / audits across the Australian and US manufacturing sites which resulted in zero critical observations. Eleven of the audits were for commercial products with the remainder being for clinical development or raw material testing by contract service customers.

During FY20, we conducted more than 90 quality audits of suppliers across the globe designed to ensure the materials and services provided by our partners meet our quality standards.