Pharmaceutical Technologist - September 2007 - (Page 26)

Compliant pharmaceutical labelling Regulations relating to labelling pharmaceutical products have become more stringent. How has technology evolved to achieve compliance in this new legislative environment? Mark Beauchamp The clear and accurate labelling of pharmaceuticals and the inclusion of accompanying instruction leaflets are now regulated by the European Parliament and other national and international regulatory bodies. As a result, pharmaceutical manufacturers and packaging companies are required to include mandatory information on medicinal products, and to ensure that this information is legible, easy to understand and indelible. While most people agree these regulations are necessary to protect patients, implementing these guidelines can require a great deal of cost and organization to achieve compliance. manufacturers (OEMs) and packaging companies must comply with when labelling pharmaceuticals and providing supporting documentation. This directive includes regulations stipulating the information that must be included in labelling, including: ● The name and contents of the medicinal product. ● Instructions for use and the method of administration. ● Warnings (e.g., Keep Out of Reach of Children). ● Special storage precautions and disposal instructions. These details must be both easy to read and indelible to ensure patient safety, and help prevent counterfeiting. The directive also legislates that a leaflet containing detailed information must be included in the packaging of medicines in circumstances where all the required information cannot be included in the labelling of the medicine container itself or its immediate packaging. Specimens are required to be submitted to the regulatory body before authorization to go to market is given, making it commercially crucial that labels are printed properly and accurately every time. Likewise, the Medicines and Healthcare products Regulatory Agency (MHRA), together with bodies such as the Department of Health, and the National Patient Safety Agency, have released a document entitled, Best Practice Guidance on Labelling and Packaging of Medicines,1 which suggests further guidelines to be followed. The guidance has no legal standing, but it is taken into account when the The regulations The European Parliament Directive 2001/83/EC provides a number of guidelines that original equipment 26 September 2007 l pharmaceutical technologist

Table of Contents Feed for the Digital Edition of Pharmaceutical Technologist - September 2007

Contents Editor’s Comment News Morpheus Market Watch CPhI Worldwide 2007 Compliant Pharmaceutical Labelling Q&A

Pharmaceutical Technologist - September 2007

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