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TGA reminds Australians of the potential danger of Pan Pharmaceuticals
The Australian public should not forget how bad the manufacturing practices were at Pan Pharmaceuticals which prompted what may be the world's biggest medicines recall.
The Therapeutic Goods Administration (TGA), in responding to a forthcoming television program about Pan Pharmaceutical's boss, Jim Selim, reminded Australians that audits of Pan found substitution of ingredients, manipulation of test results and substandard manufacturing processes.
Audits by the TGA on Pan Pharmaceuticals revealed a range of critical manufacturing deficiencies including test data being systematically and deliberately manipulated to give false results that product was within specification to enable its release into the market.
An Expert Advisory Committee, including five professors and Chaired by Dr Richard Whiting, Chairman of the Medicines Evaluation Committee, reviewed the audit reports and advised that the quality and safety concerns posed by the manufacturing breaches at Pan Pharmaceuticals needed to be urgently addressed.
In their assessment of the risks posed by audit evidence of Pan Pharmaceuticals the Expert Committee found that the multiple failures of good manufacturing practice (GMP) identified in the auditors' report created risks of death, serious illness, and serious injury.
Other safety related irregularities found at audits by the TGA included:
- manipulation of the assay results of finished products in order to comply with specifications.
- fabrication of finished product assay results of a vitamin product for export in order to comply with specifications. In two instances the product was over-strength in the other two under-strength.
- several instances of the use of beef cartilage in place of shark cartilage and one instance of use of shark cartilage in place of beef cartilage.
- poor hygiene and sanitation, equipment that was not correctly calibrated, equipment design faults giving concerns for cross contamination between different products, documentation that was deficient and the company's internal inspection program was not effective.
The action by the TGA was designed to protect the health and safety of the Australian public and followed advice received from an expert advisory group convened to give an independent evaluation of the TGA findings.
Specifically, issues identified by the Expert Group included:
- Misidentification (mix-up) of raw materials, especially herbal materials, which could lead to severe organ damage, including renal and hepatic damage;
- Cross-contamination or substitution of ingredients due to inadequate operating procedures and poor compliance with existing procedures could lead to severe allergic reactions including anaphylaxis;
- Microbiological contamination through poor raw material sourcing and handling, poor cleaning practices, and inadequate operating procedures, could lead to infections.
The Expert Group concluded that the risk would increase over time and could be realised at any time.
Specific risks included:
- Substitution of shark cartilage for bovine cartilage which could cause severe allergic reactions, including anaphylaxis, in fish-protein sensitive individuals;
- Substitution of bovine cartilage for shark cartilage where the bovine cartilage has been sourced without any assurance that it is TSE-free, and the country of origin is unknown; and
- Bovine colostrum obtained from non-approved suppliers where the raw material could be sourced from a TSE 'at risk' country, and where the source is unknown.
The Expert Group also noted a number of products described in the auditors' report for which there potentially could be safety concerns as a result of poor product quality. These included vitamin A products, pancreatic enzyme products, multiple herbal products, several OTC medicines and a prescription medicine.
The Expert Group stated it lacked confidence in the quality of any products manufactured by the company. The Group advised that poor quality products had an increased risk of failure in both safety and efficacy.
The Expert Group recommended that the company should be subject to significant remediation. The Group recommended that the company's manufacturing licence should be suspended immediately for the protection of the community's public health and safety.
Based on this report and to protect the health and safety of the Australian community, the TGA took the action to cancel the licence of Pan Pharmaceuticals and recall all products made by the company both under the Pan brand and other brands for which Pan Pharmaceuticals was the manufacturer.
The TGA did not test all of the recalled products because the TGA was advised by the Expert Committee that the failures in manufacturing practices were so bad that they created immediate risks of death, serious injury or serious illness and no confidence could be placed in the quality any products manufactured by Pan Pharmaceuticals.
There was such widespread endemic deplorable practices by the company, particularly in basic hygiene such as cleaning equipment between batches that any product ingredient was considered a potential contaminant for any other product subsequently manufactured.
The TGA confirms that there are ongoing criminal investigations into Mr Jim Selim and the practices of Pan Pharmaceuticals.
Media contact: Kay McNiece, Media Adviser, TGA 0412 132 585