Dear Valued Customers,

Our USA material is sourced from Spectrum Chemicals

Spectrum Chemicals are certified to ISO 9001:2008 and ISO 17025:2005 standards and adhere to current Good Manufacturing Practices (cGMP). All of Spectrum’s global manufacturing and distribution sites are FDA registered and operate under current Good Manufacturing Practices (cGMP) and are certified to ISO 9001 : 2008 quality standards. Spectrum adheres to strict USFDA regulations and guidelines and all applicable regulatory and quality system regulations/requirements in sourcing and qualifying all raw material manufacturing sources. They use a multitude of tools to establish a system to approve and evaluate their suppliers. On-site audits, paper based audits, regulatory review, past quality history, customer complaints, supplier corrective action responses, material quarantine and incoming material testing, etc are all components of the process Spectrum uses to provide evidence that their manufacturers can consistently provide material meeting specifications. Stringent in house testing is performed in Spectrum Chemical’s FDA certified analytical laboratories. All pharmaceutical ingredients are tested using current edition of applicable pharmacopeia.

Our bulk material is validated in line with TGA and FDA guidelines

Astral Scientific maintains strict quality control measures to ensure customers receive the highest quality material available. Astral Scientific operate as a Licensed wholesaler with the NSW Board of Health, and hold ISO 9001 :2008 quality system in pharmaceutical wholesaling and supply. In addition our Taren Point facility operates a NATA accredited and approved ISO17025 testing laboratory.

Chemicals entering our quality system are subject to a stringent program of in-house physical testing to ensure that they meet our own high quality standards. The majority of our bulk sources for high purity chemicals are GMP registered, and if GMP is not available the highest quality alternative is assessed. GMP facilities are audited by authorities such as TGA, FDA EMEA, MHRA, EU.

Our bulk sources are regular exporters to Canada and the USA, and many of our shipments are taken from parent lots bound for these destinations. All products are tested, during process and prior to dispatch to appropriate monograph or relevant specification.
APIs are further QA tested and clean room packaged at the manufacturing facility and then labelled and exported to Astral in original, unopened packaging.

Astral Scientific’s ISO 9001 : 2008 and ISO17025 quality systems ensure cradle to grave traceability of our imported materials. In addition
to Certificate of Analysis and SDS, physical characteristic and identification reports such as HPLC, MS, NMR, impurities, residual solvents assays are available on all GMP materials. Data as per module 3.3.S.1-7 DMF including 6 months accelerated and long term stability tests are available on many materials.

In line with our quality assurance, materials are cross checked to full monograph in TGA / NATA approved labs, further validation is performed by large end user in house qualification. Physical checks are performed on material prior to entering the system. Quality records are then maintained and customer feedback is monitored to ensure that high standards remain a constant. Our warehouses operate with current GMP standards and material is distributed in original condition direct from manufacturer.

We do not open or repack the API material imported.

APIs are imported to Australia in line with relevant TGA regulations and as such are classified as TGA approved material for compounding.