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 Certification Documentation

D141 : ISO 15378:2015 Documentation Kit for Medicinal Product Packaging Material Manufacturers

899.00 USD Demo

The ISO 15378 Documentation is developed to medicinal products packaging material manufactuer's certification as per ISO 15378:2015 requirements. Organizations involved in packaging material manufacturing for medicinal products looking ISO 15378:2015 certification, which covers requirements of ISO 9001 with reference of Good Manufacturing Practices(GMP). The ISO 15378 certification requires specific set of documents for system implementation. This readymade ISO 15378 documentation kit is designed to minimize the time and cost involved in certification as well as provides better control over implemented QMS system.

The Documentation kit for ISO 15378 contains quality manual, procedures, exhibits, SOPs, forms and audit checklists etc., which are primary requirements for documentation to ISO 15378:2015. The total documents are designed under guidance of experienced ISO consultants and QMS auditors. All files in ISO 15378 document kit are designed in editable word templates and cover all the requirements of ISO 15378 certification, a standard for primary packaging material for medicinal products. The key advantage of ISO 15378 documents are popular for its user compatibility feature; all the documents are in editable word files. It is globally used documentation tool available with ISO 15378:2015 clause-wise requirements. The user can update sample document templates as per organization working system and create own documents for their medicinal products packaging material manufacturing company in just couple of mandays.

 

Content of ISO 15378:2015 Documentation Kit

The ISO 15378 Documentation kit - primary packaging material for medicinal products with reference to quality management system and GMP contains a set of total 150 editable word files. All these files are based on requirements of ISO 15378:2015 standard, includes following readymade templates that can be used as a ready reference tool to accelerate documentation process for ISO 15378 certification.

  1. ISO 15378 Manual - Editable quality manual with 08 chapters and 05 annexure for primary packaging material for medicinal products with reference of ISO 9001 and GMP requirements.
  2. Mandatory Procedures - total 18 ISO 15378 procedures in word format for various process requirements for better control of implemented system.
  3. Exhibits - sample copy of 04 exhibits that covers all the details of skill requirements and quality plans.
  4. Readymade Formats - Total 43 blank editable sample forms to maintain records as well as establish control and make system as per QMS requirements.
  5. Process Approach - total 12 process approaches with flow charts that defines all the details of all the departments for better implementation.
  6. Standard Operating Procedures - 61 SOPs in editable formats that required for defining standard operations as per ISO 9001 and GMP guidelines.
  7. ISO 15378 Audit Checklist - More than 500 sample audit questions for clause wise and department wise requirements, which works as ready reference tool for quick auditing.

  Features
  • Written in simple English.
  • All files are in MS Word 2007 and compatible with window 1997 and higher version.
  • ISO 15378 Documents are user compatible, easy to learn the requirements and easy to use.
  • Anyone can download FREE ISO 15378 DEMO with list of documents that helps to take quick purchase decision.
  • All documents are designed under guidance of experienced QMS consultants.
  • Contains ISO 15378 manual, mandatory procedures, process approaches, SOPs and sample formats which are complete set of documents as per ISO 15378:2015 standard with reference to GMP.
  • User-friendly and easy to update, which minimize excessive paper work.
  • Defines the baseline system that satisfies requirements for ISO 15378 as well as covers quality management system and good manufacturing practice principles.
  • Most compatible for GMP based ISO 15378 documentation for companies in USA, UK, Europe and Asia.
 

How Documents are Useful in ISO 15378 Certification?

  • Complete set of manual, procedures, process flow charts and templates etc., takes care for all the section and sub sections to get better confidence as well as improve the quality system.
  • The user can modify readymade templates as per their working system and create own documents for quick ISO 15378:2015 certification.
  • Procedures and formats are provided in document kit can help in fine-tuning the processes and establish better control over Good manufacturing practices.
  • Documentation kit saves much time and cost in document preparation.
  • It gives value for money to the customer and payback for this product is very low.
  • Ready to use templates in .doc format will increase level of accuracy and minimize repetitive work while documentation process.
  Other Details

Method of Delivery for ISO 15378 Documentation Kit

The ISO 15378:2015 Documents for primary packaging material for medical products can be purchase through secure online transaction via third party payment gateway. The soft-copy of ISO 15378 Documentation Kit shall be delivered online after 12 hours of confirmation of payment; we are giving username and password with download link to the buyer.

Note: All the documents are editable and all rights of using at one site will be given to buyer for changing company name, logo etc as per company system requirements.

This product kit softcopy is now on sale. This product is delivered by download from server/ E-mail.

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D141 : ISO 15378:2015 Documentation Kit for Medicinal Product Packaging Material Manufacturers 899.00 USD Demo