Pharmaceutical quality system recalls

For Recall as a part of the Pharmaceutical Quality System, see also Sect. 35.6.14. 

The EU-GMP comprises 3 parts. Part 1 encompasses 9 basic chapters on medicines Pharmaceutical Quality System, Personnel, Premises and Equipment, Documentation, Production, Quality Control, Outsourced activities. Complaints and Product Recall, Self Inspection. Part 2 is about the production of active substances. Part 3 contains about 20 related documents such as a site master file and several annexes (see also Sect. 35.5.7). 

In April/May 2003 the TGA forced the recall of approximately 1600 complementary medicines at retail level throughout Australia, due to concerns about the quality of their manufacture. The recalled products were manufactured in Australia by Pan Pharmaceuticals, principally as a contract manufacturer for other companies. The resultant publicity impacted around the world and highlighted the importance of effective implementation of GMP standards for all therapeutic products. In view of the issues raised by this massive recall, and to restore community confidence, an Expert Committee on Complementary Medicines in the Health System was established to consider a wide range of matters relating to complementary medicines. Their report was published in September 2003 and is available from the TGA website. 

Once the business processes have been agreed, a GxP assessment can be conducted. This should address those operational aspects of the system that impact the quality of finished pharmaceutical products and will include supplier details, batch records, laboratory quality control records, batch release, and recall. An example of a GxP impacting functionality in an MRP 11 system is given in Appendix 35F. Experience suggests that perhaps between 25 to 50% of MRP 11 functionality is GxP critical. The GxP operational aspects will form a focal point during any GxP regulatory... 

It must be recalled that the World Health Organization (WHO) perceived the International Pharmacopoeia as a means of harmonizing quality specifications of pharmaceutical substances internationally. As long as WHO efforts are not given any legal status per se as they are, at best, mere recommendations, then other steps have to be found to affirm quality. It must be stated however that in 1981 the WHO Expert Committee on Specifications for Pharmaceutical Preparations reviewed the whole system and came out with its Twenty-Eight Report with clearly defined functions and characteristics of the International Pharmacopoeia. 

Without a quality assurance system, organizations risk sourcing substandard, counterfeit or contaminated pharmaceutical products, leading to complaints about products and product recalls, wastage of money and serious health risks to patients. Such problems affect the credibility of procurement agencies, cause financial losses and put patients safety in danger. Background... 

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