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PROMOTION


IN SEARCH OF QUALITY FOR BoNT PRODUCTS


Andy Pickett discusses the importance of regulation and testing botulinum toxin products so that health professionals and patients can be assured of their quality


estimates put the annual number of injections worldwide at over 10 million1


T


ANDY PICKETT IS Director and Founder, Toxin Science Limited, Wrexham, UK; and Adjunct Professor, Botulinum Research Center, UMASS Dartmouth, USA


Contact information: Andy.Pickett@galderma.com


s“The initial tandards of


quality for the BoNT


products were established in the 1980s with the original companies involved in BoNT


manufacture. 56 ❚ ” , with a substantial


increase in the US alone over the last few years (Figure 1). Exact figures do not exist; they are not collected or collated in many countries. As the different professional disciplines, including injectors, also grows continually (see example of the UK alone, Table 1), hard data become evermore difficult to find.


Product regulation BoNT availability is highly regulated. The commercially-available products are prescription-only medicines that are not freely available to patients, even for aesthetic use2


. Such


restrictions are only to be expected for highly potent, biological products with powerful actions in vivo. However, these restrictions also ensure that the quality of the products is to the highest possible grade, providing assurances of both safety and efficacy for patients. Each batch of BoNT product released for commercial sale must meet both registered specifications and quality standards, and must also be independently tested and certified by an international test authority before use3


. Without such


certification, no batch of product can be sold in Europe.


In addition, BoNT product


manufacture, always under the umbrella of Good Manufacturing Practice4


, is subject to rigorous


inspections by national regulatory authorities to ensure, once again, that products reaching their countries also meet their standards. Within Europe, one country —normally the national country of the manufacturer—carries out these inspections at least every 2–3 years5


. Additional inspections


will be carried out by the US, Canada and countries such as Brazil, Japan, Russia, and even Iran3


. Overlying all of these checks and


controls, the companies are obliged, by regulation and law, to carry out both internal audits of each quality and production function, often on a yearly basis, together with audits of their suppliers. Everything from the


November/December 2012 | prime-journal.com


raw materials used in manufacture through to the vials that the products are supplied in is included; even the suppliers of the disinfectants used to clean the high quality production facilities must be audited. Without these independent audits, performed by the quality assurance functions within the organisations, the manufacturers would not meet the required quality standards from any country.


Issues of quality Quality is deeply built into the products that are supplied. Quality is present at every stage, every test, every result. Even the personnel working in quality control and manufacturing areas are quality controlled, to ensure their training is always up-to-date. In fact, it is an essential element of any regulated


HE CONTINUAL RISE in the use of botulinum toxin (BoNT) for aesthetic treatments relentless.


is Current


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