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Pharma company voluntarily stops manufacturing
Australia's medicine watchdog, the Therapeutic Goods Administration (TGA), has confirmed that a subsidiary company of Australian Pharmaceutical Industries Ltd, Soul Pattinson Manufacturing Pty Ltd, has asked the TGA to suspend its licence while it upgrades its manufacturing procedures to meet TGA standards.
An unannounced audit of Soul Pattinson Manufacturing's Sydney factory on 28-30th July 2003 revealed serious breaches of manufacturing standards which relate primarily to the run down condition of plant and equipment and some inadequate quality control systems.
Unlike Pan Pharmaceuticals, there was no evidence of fraud, substitution of ingredients or manipulation of test results. Auditors were satisfied that the company had consistently tested its products before putting them in the marketplace.
Additionally, the TGA tested a sizeable sample of the company's goods and found no unsafe or incorrectly formulated products and, therefore, determined that there was no need for a consumer level recall of any of the company's products.
However, the TGA will not tolerate bad manufacturing practices which could lead to inferior products being marketed to consumers and Soul Pattinson Manufacturing Pty Ltd has been warned that it must improve standards before gaining its manufacturing licence back.
Following the first audit, the TGA in accordance with legislative requirements, gave the company reasonable time, in this case 10 days, to rectify all of the concerns identified. Despite the best efforts of the company to comply, a further audit by TGA showed that there was still some work to be done to satisfy the TGA that Good Manufacturing Practices were being followed.
The company, which has cooperated completely with the TGA, manufactures a wide range of over-the-counter and complementary medicines in tablet, capsule, cream, ointment and liquid dosage forms. Soul Pattinson Manufacturing Pty Ltd undertakes its own brand-name products and manufactures under contract for other companies.
It also manufactures six prescription medicines. Two of the products, Melleril Suspension and Linctus Codeine are listed on the PBS.
The TGA has formally suspended the company's licence to manufacture for an initial six weeks period during which time the company must rectify all identified problems to regain its manufacturing licence.
Media contact: Kay McNiece, Media Adviser, TGA 0412 132 585