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 Certification Documentation

D139 : GMP ICH Q7 Documentation Kit for Pharmaceutical Manufacturers

599.00 USD Demo

The GMP Q7 Documentation is developed to guide pharmaceutical manufacturers for Good Manufacturing practices - GMP certification as per ICH Q7 requirements for API manufacturers in pharmaceutical industry. Good Manufacturing Practice certification for API (Active Pharmaceutical Ingredients) ensures that products are consistently produced and controlled according to quality standards without contamination. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

The GMP Documentation kit for pharmaceutical manufacturer contains GMP manual, procedures, process approach, SOPs, forms, exhibits and audit checklists etc., which are primary documentation requirements. The GMP documentation kit is designed by Global Manager Group contains ready to use sample templates, which cover all the requirements of GMP ICH Q7 certification, a popular standard in pharmaceutical manufacturers. The key advantage of our GMP documentation kit for pharmaceutical companies is its user compatibility feature; all the documents covered in 165 MS Word files are editable and written in simple English. It is globally used GMP documentation tool available with easy editing features and compatible with clause-wise requirements. The user can update sample document templates as per organization working system and create own documents for their manufacturing company in just couple of man days.

 

Content of GMP Documentation - Manual, Procedures, Checklists

The GMP Documentation kit for pharmaceutical manufacturers - A set of total 165 editable files is based on requirements of GMP ICH Q7 standard includes following readymade templates that can be used as a ready reference tool to accelerate documentation process for GMP Certification.

  1. GMP Manual - 01 editable file that define Good Manufacturing Practice guidance and requirements.
  2. GMP Procedures - total 08 mandatory procedures in word format for various requirements as well as technical reviews of products and manufacturing process for active pharmaceutical ingredients.
  3. GMP Process Approach - total 10 process flow chart and approaches for various departments of an organization.
  4. Standard Operating Procedures - Total 74 SOPs for management, operation, training and audit etc., to use as reference documents.
  5. Exhibits - 06 editable exhibits in word files for GMP Q7 skill, quality requirements for pharmaceutical manufacturers.
  6. Readymade Formats - 53 editable sample forms and templates to maintain records as well as establish control to make Good Manufacturing Practices effective.
  7. GMP Audit Checklist - More than 800 audit questions based on GMP ICH standard. It helps auditor to make own GMP audit checklists for quick and perfect auditing.
  Features
  • Written in simple English.
  • Written in MS Word 7 and compatible with window 1997 and higher version.
  • GMP Documents are user compatible, easy to learn and easy to use.
  • Anyone can download FREE DEMO with list of documents and document matrix that helps to take quick decision to purchase this documentation kit.
  • All documents are designed under guidance of experienced consultants.
  • Contains GMP manual, mandatory and quality procedures, exhibits, SOPs and sample formats which are complete set of GMP documentation as per GMP ICH standard.
  • User-friendly and easy to learn, which minimize excessive work.
  • Defines the baseline system that satisfies requirements for GMP ICH Q7 as well as covers good manufacturing practices principles.
  • Most compatible for GMP documentation for pharmaceutical companies in USA, UK, Europe and Asia.
 

How GMP Documents Templates are Useful?

  • Complete set of manual, procedures, templates etc., takes care for all the section and sub sections to get better confidence as well as improve the system.
  • The user can modify readymade templates as per their working system and they can create own documents for quick GMP 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 for GMP Certification for pharmaceutical manufacturers.
  • It gives value for money to customer and payback is very low.
  • Ready to use templates in word format will reduce your time in documentation process as well as useful in giving training to staff.
  Other Details

Method of Delivery for GMP Documentation Kit

The GMP Documents for pharmaceutical manufacturers can be purchase through secure online transaction via third party payment gateway. The soft-copy of GMP ICH Documentation Kit for API manufacturer shall be delivered online after 12 hours of confirmation of payment; we are giving username and password with download link to the buyer for ftp download.

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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D139 : GMP ICH Q7 Documentation Kit for Pharmaceutical Manufacturers 599.00 USD Demo