Pharmaceuticals - , ,
# We are your Online resource center to GMP/GEP 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 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 startup 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.Visit our website www.gmptemplates.com and download sample templates and guidelines: 1) Process Flow Diagram on Good Engineering Practice 2) A simple Quality-System Model for GMP Projects 3) GMP/GEP Facility Design Checklist 4) Typical Steps to Implement a Quality Management System
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