The benefits of implementing good manufacturing practices (GMP) and quality management could be made easier for the pharmaceutical industry with a new standard from the International Organization for Standardization. ISO 15378:2006, "Primary packaging materials for medicinal products—Particular requirements for the application of ISO 9001:2000 ", represents an international consensus on good practices and establishes a benchmark that can be applied for quality improvement, training, auditing and certification. Developed with experts from the pharmaceutical sector, the standard incorporates ISO 9001’s quality management requirements and GMP for the design, manufacture and supply of primary packaging materials for medicinal products. In addition, it provides guidance on risk management and validation.

“The standard is of vital importance to the pharmaceutical industry and its suppliers of pharmaceutical primary packaging materials,” says Jürgen Thürk, convenor of the working group that developed ISO 15378:2006. “For the first time, the principles of good manufacturing practices are specified as part of an ISO standard.”

For more information, visit www.iso.org.

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