Overview on ISO 15378:2015 Documentation

An Overview on ISO 15378:2015 Documentation

By Global Manager Group

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What is ISO 15378?

ISO 15378:2015 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organisations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products.

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Why is ISO 15378 Important?

The ISO 15378 Standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life.

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Benefits of ISO 15378:2015 Certification  Helps organizations in the pharmaceutical and medicinal primary material packaging products manufacturing sector to minimize or eliminate instances of contamination, mixups, and manufacturing errors. Procedures Improves efficiency and cost effectiveness of your business operations.  Provides guidance on risk management and validation  Ensures consistently meet customer requirements, including regulatory requirements.  Additional assurance of quality products to your clients.  Enhancement in processes.  Evidence of adherence to legal requirements and contractual obligations.  Clear statement of the organization's competence.  Saves time and costs in day to day practice as per GMP guidelines.

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ISO 15378:2015 Documentation Requirements Organizations that involved in packaging material manufacturing for medicinal products looking for ISO 15378:2015 certification, which covers requirements of ISO 9001 with reference of Good Manufacturing Practices(GMP). There are specific ISO 15378:2015 documentation requirements that need to be fulfill which provides better control over implemented QMS system. . List of such requirements for better understanding quality system as per ISO 15378:2015 are as below:  ISO 15378:2015 Manual  Procedures  Exhibits

 Sample Forms and Templates  Standard Operating Procedures (SOPs)  ISO 15378:2015 Audit Checklist www.globalmanagergroup.com

ISO 15378:2015 Manual ISO 15378:2015 Manual states the ISO 15378 policy and describes the ISO 15378 system of an organization. It may relate to an organization’s total activities or to a selected part of it, e.g. specified requirements depending upon the nature of products or services, processes, contractual requirements, governing regulations etc. It should include how ISO 15378:2015 system is implemented in the organization at macro level.

ISO 15378:2015 manual should normally contain, or refer to:  Introduction  Management Responsibility  Resource Management  Product Realization  Measurement, Analysis & Improvement www.globalmanagergroup.com

ISO 15378:2015 Procedures ISO 15378 procedures are also called operational procedure, as they are a snapshot of the actual activities taking place in a company at a particular point of time. They are considered to be the core of the system documentation for ISO 15378:2015 achievement and assurance and confidential documents. They are intended for internal use and should be protected from misuse. These procedures are meant to instruct in broad terms, how the policies and objectives expressed in the ISO 15378 manual are to be addressed and achieved.

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Exhibits The ISO 15378 Exhibits are very helpful tool to teach all employees and staff about how to implements and improvements quality requirements for medicinal product and get number of benefits. Following are list of Exhibits covering all the details of ISO 15378:2015 requirements.  Skill requirements  Disposal of Non – conforming products

 Quality Plan  Document codification system

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Sample Forms and Templates Sample forms, records etc. are supporting documents used by the company to record information for different procedures followed. They link the activities written in the procedure to the records kept in the department. This documentation serves to demonstrate that the ISO 15378 system is operating efficiently to produce the product in accordance with specified requirements of the ISO 15378:2015 system. They should be legible, easily retrievable and available when asked for by the auditor. On all the forms establish proper document control on them.

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Standard Operating Procedures All associates have the responsibility to ensure that all activities are performed according to the official SOPs, any deviations in procedure are reported to their supervisor and are adequately documented. ISO 15378 SOPs should provide specific step-by-step instructions for performing operational tasks or activities.

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ISO 15378:2015 Audit Checklist The ISO 15378:2015 Audit Checklist is a good tool or the internal to make audit questionnaire while auditing and make effectiveness in auditing. It covers sample audit questions based on all the ISO 15378:2015 requirements. It can be used as a very good tool for logically auditing during internal audit for medicinal products packaging material manufacture's certification. During internal audit verification of system to meet ISO 15378:2015 requirements helps for smooth certification audit.

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ISO 15378:2015 Documentation Kit Global Manager Group provides ISO 15378:2015 Documentation kit that having sample documents required for ISO 15378:2015 Certification. It contains all documents that covers all such requirements standard. The ISO 15378:2015 manual to ISO 15378:2015 audit checklist are provided in editable format that serves as the primary source of documentation.

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Global Manager Group Global Manager Group is the first company that introduces Online Consultancy by offering International System Certification Documentation and Auditor Training Packages available on website @ www.Globalmanagergroup.com

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