Your online store for document templates for:

Quality Management System QMS

Good Engineering Practices GEP & Other Topics

OUR PRODUCTS AND SERVICES

1. We are your resource centre for GMP document templates for Life Science, FMCG & Critical Facilities:
• Policies, Standard Operating Procedures (SOP), Work Instructions, Checklists, Systems and Forms
• Engineering Best Practices, Tools and Calculations
• Guidelines and Whitepapers

1. Topics include: (Our templates are grouped into Main Categories and Sub-Categories)

MAIN CATEGORIES:

1. 1. Quality Management System (QMS) based on:
      • FDA, PIC/S, ICH-Q10, EU, ISO-9001, ISPE, ASTM, WHO, TGA
   2. Good Engineering Practice (GEP) inline with International Society of Pharmaceutical Engineering (ISPE)
   3. Purified Water System (WFI) – design, construction, testing, operation & maintenance – inline with US/European Pharmacopoeia (USP, EP) 
   4. GMP Facility Design & Construction Guidelines
   5. Engineering Standards and Systems.
   6. Environmental Health & Safety (EHS)

Where Do I start?

1. Is there a specific topic you are looking for – do a Search

2. For an ENGINEERING topic – there are two options:

• open, download and print the FREE GEP (GOOD ENGINEERING PRACTICE) Flowchart. Use the flowchart as a reference for the next step.  The PDF flowchart contains “Hyperlinks” to open the Webpage.
• Alternately – Go to “PRODUCTS – MAIN CATEGORIES” (below)

3. For a QUALITY ASSURANCE (QA) or organizational topic –

open, download and print the FREE QMS (Q00-0001 Quality Management System Flowchart) Flowchart. Use the flowchart (roadmap) as a reference for the next step.  The PDF flowchart contains “Hyperlinks” to open the Webpage.

Go to “PRODUCTS – MAIN CATEGORIES” (below)

4. Contact Us – if you need some help or email info@gmptemplates.com

Good Engineering Practices (GEP) &
Other Engineering Topics

Click on Flowcharts to open the PDF file.
The “CATEGORIES” in the PDF Flowcharts contain “hyperlinks” to open the corresponding Webpage.

PRODUCTS –  MAIN CATEGORIES (by Topics)

Our GMP Templates:

• Industry proven document templates & forms
  – have been implemented in companies from multinationals to small start-up companies.
• Our document templates cater for both Client (manufacturers) and Equipment Vendors, Contractors, Suppliers, Service Providers.
• Using of templates and guidelines will reduce the amount of time the user needs to spend on researching and developing any process and document within a GMP environment.
  • Reasons to buy our templates:
  • to give you a quick starting point for your final document
  • most of our documents will give you options to benchmark your standard against industry’s
  • Most of our documents have been implemented in established regulated facilities – this can be used to set the basis of your document.