Review of TGA's Position in Pan Pharmaceuticals Recall and Compliance Breaches

Almost three months ago, The Australian Therpaeutic Goods (TGA) administration suspended the manufacturing license of Pan Pharmaceuticals, manufacturer of pharma, OTC and supplement products for Australian and International markets. At that time, a widespread recall of Pan manufactured products was initiated, dspite the fact, that at least initally, no safety risk had been associated with the compliance breaches.

The product which was a significant trigger for the TGA's action was an OTC product (Travacalm) and is the only product associated with any direct adverse reaction. In this case, an excess of active ingredient and variability in product uniformity within the bottle was responsible, suggesting serious quality control breaches existed. Further investigation of Pan manufacturing and quality control practices appears to support this.

The recall action had an impact on the vitamins, nutritional and herbal product sectors, within Australia and abroad. At first, it was stated that Pan was responsible for the production of up to 70 percent of products on the market, a figure that has subsequently been revised downward to 40% of the Australian vitamin nutritional market including approximately 30% of the soft capsule market.

Many questions have been asked of the regulators, including why the action was taken against non-pharma products, especially if there was no apparent safety risk. The government has responded by expanding on the list of quality breaches it identified with Pan practices in quality control and manufacturing and by stating the problems discovered in the TGA audit were "endemic and widespread" including "nine critical breaches of the code of good manufacturing practice" and that an expert committee determined that there was, in fact, a risk of death, serious illness or serious injury.

The list of breaches cited include:
-lack of adequate controls
-at least one product manufactured contrary to Pan's license
-raw data manipulation
-finished product result fabrication
-product substitution
-deficient raw material and finished product control
-breaches of marketing authorizations
-deficiencies in document and record management and control
-cross-contamination issues

The agency suggests that the list and scope of the breaches was so vast with significant potential implications, that widespread action was required, hence the emergency recall. Further action by the agency has been proposed which may include criminal charges.

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