Certification Documentation

GMP ICH Q7 Documentation Kit for Pharmaceutical Manufacturers

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D139 :
GMP ICH Q7 Documents

$599

GMP documents contain more than 165 editable MS-Word files. These editable documents address all the elements for pharmaceutical manufacturers

Content of GMP ICH Q7 Documentation Kit for Pharmaceutical Manufacturers

The GMP Documentation kit for the pharmaceutical manufacturers - A set of total 165 editable files - is based on the requirements of GMP ICH Q7 standard. The GMP Documents include 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 defines good Manufacturing Practice guidelines and requirements.
  2. GMP Procedures: total 08 mandatory procedures in MS-Word format for various requirements as well as technical reviews of products and manufacturing processes for active pharmaceutical ingredients.
  3. GMP Process Approach: Total 10 process flow charts and approaches for various departments of an organization.
  4. Standard Operating Procedures: Total 74 SOPs for management, operation, training and audit teams to use as reference documents.
  5. Exhibits: 06 editable exhibits in MS-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 an auditor to make their own GMP audit checklist for a quick and perfect auditing.
Features
  • The documents are written in easy to understand English language.
  • The documents are prepared in MS-Word 2007 formats. They are compatible with Windows 1997 and higher versions.
  • The entire GMP Documents are user compatible, easy to learn and easy to use.
  • Anyone can download FREE DEMO with the list of documents and document matrix that helps them to take a quick decision to purchase this documentation kit.
  • All documents are designed under the guidance of experienced consultants.
  • The documentation kit contains:
    • GMP manual,
    • mandatory and quality procedures,
    • exhibits,
    • SOPs and sample formats
    The entire kit contents are a complete set of GMP documentation as per GMP ICH standard.
  • The kit contents are user-friendly and easy to learn, which minimize excessive work.
  • The documentation kit defines the baseline system that satisfies requirements for GMP ICH Q7 as well as covers good manufacturing practices principles.
  • The kit is most compatible for GMP documentation of pharmaceutical companies in the USA, UK, Europe and Asia.
How useful?
  • It is a complete set of manual, procedures, templates and others. The kit takes care of the entire sections and sub sections to get a better confidence as well as improve the system.
  • The user can modify readymade templates as per their working system. They can create own documents for quick GMP certification.
  • The document kit provides procedures and formats. These can help to fine-tune the processes and establish better control over god manufacturing practices.
  • The documentation kit saves much time and cost of document preparation for GMP Certification for pharmaceutical manufacturers.
  • It gives value for money to our customers and payback is very low for them.
  • These ready-to-use templates in MS-Word format will reduce your time in documentation process as well as they can be used in training the staff.
Other Details

We have developed the GMP Q7 Documentation to guide pharmaceutical manufacturers for good Manufacturing practices - GMP certification, in accordance with ICH Q7 requirements, for API (Active Pharmaceutical Ingredients) manufacturers in the pharmaceutical industry. A Good Manufacturing Practice Certification for API ensures that the products are consistently produced and controlled according to the quality standards without contamination. The GMP documents are designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through the testing of the final product.

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

Method of Delivery of Documentation Kit

The GMP Documents for pharmaceutical manufacturers can be purchased through secured online transaction via third party payment gateway. The soft-copy of GMP ICH Documentation Kit for API manufacturers shall be delivered online after 12 hours of the payment confirmation. On confirmation, we will provide you a username and password with a hyperlink to download he kit via for FTP server.

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

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

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