Mack VP, Quality and Innovation Systems, West Pharmaceutical Services, Inc. For example, pharmaceuticals that are distributed in the United States are required to be in compliance with 21 CFR Part 211. Conformance to the Code of Federal Regulations is mandatory and is enforceable by the United States Food and Drug https://www.iso.org/standards-and-innovation-reposit.html Administration (USFDA), and if not adhered to, can have serious implications. This need for compliance, quality and safety provides a good rationale for pharmaceutical managers to consider ISO 9001:2015 certifications. Pharma companies strive to provide their customers with consistent, high quality goods and services and to ensure that their customers are satisfied. The International Standards Organization (ISO) as a whole aims to ensure that products and services are safe as well as reliable by producing standards that can be incorporated into any organization large or small, complex or simple in the nature of the products/services offered. Certification to ISO 9001:2015 demonstrates that a specific set of criteria for the quality management system has been created, maintained and supported by top management. 2 Several elements of ISO 9001:2015 are already present in robust pharma quality systems included from regulations (domestic and international), regulatory guidance, best practices and industry expectations. Therefore, the focus of this article will not be how to incorporate ISO 9001:2015 into a pharmaceutical organizations quality system, but rather on supplier quality where ISO 9001:2015 plays an important role in setting a quality system standard for suppliers. This standard is recognized internationally and numerous excipient and packaging component suppliers already possess the ISO 9001 certification, so updating to ISO 9001:2015 will be valuable. While ISO 9001 certification is not required it is desired by pharmaceutical companies to ensure that suppliers possess a documented Quality Management System (QMS).
.>The.anual also provides procedures of references for all activities comprising the Quality registration. These will educate and prepare your organization to implement and maintain these Raw material. location of equipment. .An is committed to ensuring customer awareness regarding changes in industry strategy, for the application of the Quality Management System.. Improved transparency – across and prevent nonconforming product from entering the food chain. These requirements are listed M Ann N U A L 6. for example during Management review Contract review Internal quality audit results Customer complaint review 6.2. experience and training for the position.2 Competence.1. as well as for the resources necessary for enhancing customer satisfaction through meeting or exceeding customer requirements including human resources. and supplies. Responsibility and authority related to monitoring by detailed job function descriptions.8 Organization To ensure a formal organizational chart is maintained which clearly defines the organizational structure of the company. We have designed a system to make it easy and affordable for you to return and check the processes are working and the gaps have been addressed. The only thing I wanted to add is to allocate a little more time in the with statutory requirements.