OUR PRODUCTS AND SERVICES

  • We are your resource centre to document templates for Life Science, FMCG & Critical Facilities:
    • Policies, Standard Operating Procedures (SOP), Work Instructions, checklists, Systems and Forms
    • Engineering tools and calculations
    • Guidelines and whitepapers

  • Topics include:

    • Quality Management System (QMS) 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.
  • Industry proven document templates & forms
    – have been implemented in companies from multinationals to small start-up companies.
  • Our document templates caters 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.

Where Do I start?

  1. Is there a specific topic you are looking for – do a Search
  2. If it is an ENGINEERING topic –
    1. open, download and print the FREE GEP (GOOD ENGINEERING PRACTICE) Flowchart e00-01-02_gep_flowchart. Use the flowchart as a reference for the next step.
    2. go to Good Engineering Practice (GEP) for a description of the Sub-Categories and topics
    3. Find the topic that you are looking for; go back to the website and open the Category or Sub-Category for the template
  3. If it is a QUALITY ASSURANCE (QA) or organisational topic –
    1. open, download and print the FREE QMS (QUALITY MANAGEMENT SYSTEM) Flowchart q00-00-01_qms_flowchart  Use the flowchart as a reference for the next step.
    2. go to Quality Management System (QMS) for a description of the Sub-Categories and document templates
    3. Find the topic that you are looking for; go back to the website and open the Category or Sub-Category for the template
  4. Contact Us if you need some help or email info@gmptemplates.com