We are 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.
