Your online store for Good Manufacturing Practices (GMP) document templates:

    • Quality Management System QMS
    • Good Engineering Practices GEP & Other Topics

    OUR PRODUCTS AND SERVICES

    • We are your resource centre for GMP document templates for Life Science, FMCG & Critical Facilities:
      1. Policies, Standard Operating Procedures (SOP), Work Instructions, Checklists, Systems and Forms
      2. Engineering Best Practices, Tools and Calculations
      3. Guidelines and Whitepapers
    • Topics include: (Our templates are grouped into Main Categories and Sub-Categories)

            MAIN CATEGORIES:

      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:
    3. For a QUALITY ASSURANCE (QA) or organizational topic –
    4. Contact Us – if you need some help or email [email protected]
    Quality Management System (QMS)
     

    Good Engineering Practices (GEP) &
    Other 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:
        1. to give you a quick starting point for your final document
        2. most of our documents will give you options to benchmark your standard against industry’s
        3. Most of our documents have been implemented in established regulated facilities – this can be used to set the basis of your document.