GMP templates.com

Company Description

GMP templates.com your Online Shop for GMP / GEP (Good Engineering Practice) / QMS (Quality Management System) document templates for Life Science (pharmaceutical, biotechnology, medical devices), FMCG & Critical Facilities. Types of document include:

* Policy Statements, Standard Operating Procedures (SOP), Work Instructions, checklists, Systems and Forms
* Engineering tools and calculations
* Guidelines and whitepapers

Topics include:

* Quality Management System based on:
FDA, PIC/S, ICH-Q10, EU, ISO-9001, ISPE, ASTM, WHO, TGA
* Good Manufacturing Practice (GMP)
* Good Engineering Practice (GEP)
* Purified Water System (WFI) - design, construction, testing, operation & maintenance
* GMP Facility Design & Construction Guidelines
* Engineering Standards and Systems.

WHO NEEDS THESE TEMPLATES:
* Pharmaceutical manufacturers to setup their GEP, Quality Management System and essential documents for compliance eg qualification, validation, QA, QC
* Equipment and machinery manufacturers - improve the marketability of your product by supplying your customers with the essential processes and documents for qualifications and validation.

FREE DOWNLOADS:
We have complementary documents for you to download at our website, www.gmptemplates.com for example:
* GMP Facility Design Checklist
* A Simple Quality System for GMP Projects

ABOUT US:

* We are a network of professional scientists, engineers, technicians and administrators.
* Together, we have decades of hands-on practical experience in the preparation and execution of processes and documentation in the regulated and mission critical environment.
* We seek to share our experience, skills and knowledge with you.
* Our Team Members have worked for, consulted to and executed projects for clients of all magnitudes, and from both sides of the fence ie as a Client (manufacturer) and as a Vendor/Contractor.

Company Information

  • Contact Person:Mr. info gmptemplate
  • Department:Sales
  • Job Title:Manager
  • Telephone:
  • Zip:2065
  • City:Sydney
  • Business Type:Manufacturer
  • Year Established:1999
  • Number Of Employees:Fewer than 5 People
  • Total Revenue:Below US$1 Million
  • Trade Capacity:North America : 16.67% Southeast Asia : 16.67%
  • Production Capacity:- -
  • Main Products:GMP Document Templates, Quality Management System Services, Validation Protocols, Good Engineering Practice - Standards And Systems, Pharmaceutical Quality System Document Templates, Pharmaceutical Equipment Quality System, Biotech Quality Management System, Pharmaceutical Consultancy, Purified Water WFI System, Good Engineering Practice, Quality Management System
  • Address:2 Atchison Street
  • Main Markets:North America, Southeast Asia, Mid East, Eastern A
  • Location:New South Wales, Australia
  • Website:Visit website

Product

  • Pharmaceutical Purified Water WFI System - Design Sizing Estimate
  • GMP Quality Management System - Policy Statement
  • Policy Statement - Good Engineering Practice Pharmaceutical
  • E10-02 Design Guideline for Water-for-Injection WFI
  • E03-5000 A Simple Quality System for GMP Projects/Equipment
  • E10-01 Purified Water System - Design Input
  • E10-01 Purified Water System - Design and Operation Guidelines
  • E03-5000 A Simple Quality System for GMP Projects/Equipment
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