Sypharma has many years experience in developing, manufacturing and marketing of therapeutic goods, hospital products, consumer products & veterinary products. We contract manufacture products for a range of companies for both the local and international markets.
It is Sypharma policy that Quality is built into all aspects of development, manufacturing and service, to provide the customer with the highest level of satisfaction. Both Human Therapeutic and Animal Health divisions shall comply with their relevant standards and specifications pertaining to the Code of Good Manufacturing Practice requirements to ensure they have the safety, identity, purity, effectiveness and quality expected by the customer and regulatory agencies.
Manufacturing Qualifications and Standards
Sypharma is a Good Manufacturing Practice (GMP) compliant manufacturer and performs under the requirements of ISO13485. A comprehensive Qualification and Validation Program is adhered to in order to prove control of the critical aspects of the production operations. Not resting on our laurels, the Sypharma team work to continually improve our systems, responding to ever changing regulatory and customer requirements.
All procedures used by Sypharma are regularly audited by means of internal audits for ongoing compliance and systematic improvement. These independent audits plus a comprehensive and rigorous internal testing schedule form part of the intensive program that Sypharma undertakes.
Experience and Expertise
There are approximately forty full-time employees on site, engaged in production, quality assurance and control, maintenance, administration, warehousing and distribution. A large proportion of our staff forms the quality management team. We pride ourselves on our local and internationally experienced staff, with many years of consolidated experience in all aspects of Quality Control, Quality Assurance and dedicated validation staff.
Sypharma holds a Therapeutic Goods Administration (TGA) licence to manufacture, package and store non-sterile & terminally sterilised medicinal products for human use, and an Australian Pesticides and Veterinary Medicines Authority (APVMA) manufacturing licence for Category 2 & 4 veterinary products. All manufacturing is compliant with the Code of Good Manufacturing Practice for Therapeutic Goods.
All therapeutic goods manufactured and marketed by Sypharma comply with the Therapeutic Goods Administration (TGA) and the State Department of Health. Products are either registered or listed on the Australian Register of Therapeutic Goods (A.R.T.G.) administered by the TGA and comply with all labelling requirements.
By dealing with Sypharma as their contract manufacturer, Sponsors of products can be confident that their products can be manufactured, packed and released for supply to the market, all from one facility in minimal time and in compliance with regulatory requirements.