This article will help the pharmaceutical process manufacturers to update their process manufacturing software updated with the latest ISO compliances.
The industry faces an increasing challenge in managing the potential adverse effects of hundreds of thousands of prescription drugs on the market. That is where the International Organization for Standardization’s new ISO IDMP (Identification of Medicinal Products) series comes in.
Until now, there was no means of identifying drugs or medicinal substances on a global basis. This led to numerous challenges during which medicines might show adverse reactions in one country and have to be interpreted by other countries. Greater coordination among drug regulatory authorities and increased transparency in reporting suspected adverse drug reactions were needed to improve current decision-making processes.
The International Standard of Unique Medicinal Product Identification is the basis for standardizing global identification systems for medicinal products. In addition to providing easy access to product information and history, IDMP may impact companies in several areas, including research, development, manufacturing, and marketing.
Lisa Spellman, Director of Global Standards for the American Health Information Management Association (AHIMA) and Secretary of ISO/TC 215 on health informatics, believes that the advent of an international drug master file (IDMP) will change the world. “One might have thought that IDMP already existed,” Spellman said, “but it did not. Now, thanks to the ISO experts, IDMP will provide a structure and methodology to generate global product documentation that can be used by regulators and clinicians worldwide.”
The International Organization for Standardization (ISO) has published its latest guidelines, ISO IDMP, which relate to the pharmaceutical industry and include information on adverse events following the use of medicinal products. These guidelines will be of interest to all stakeholders in the life cycle of any given drug, from the point at which clinical trials are conducted to when a drug is discontinued.
Dr. Herman Diederik, An expert on the subject says, “The implementation of the International Standards Organization’s IDMP standards will enable scientists around the world to collaborate by delivering high-value substance descriptions. This document will become a reference source for scientists and information technology experts alike, a kind of unique sum of intelligence and IT architecture.”
International Organization for Standardization (ISO) standards will specify the definitions of the data elements needed to uniquely identify medical products for human use.
IDMP’s five standards are:
- ISO 11238 for substance
- ISO 11239 for pharmaceutical dose forms, units of presentation, routes of administration, and packaging
- ISO 11240 for measuring units
- ISO 11615 to regulate medical product information
- ISO 11616 to control pharmaceutical product information
The International Standards Organization (ISO) has released the International Medical Device Regulatory Affairs (IMDRF) project’s “Roadmap to Harmonization”, which is being adopted by various international health authority agencies. The US Food and Drug Administration (FDA), as well as the medicines regulator of Switzerland, have all expressed support for adoption, and Japan, Australia, Russia, and Iran have expressed varying degrees of interest. The European Medicines Agency (EMA) has mandated that the standards are in use by July 2016.
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Sangeetha brings 20 years of experience in Information Technology which includes Solution architecting, building micro services, research, and evaluation of business applications, integrating apps.