Who gmp guidelines pdf
[DOC File]PHARMACEUTICAL INSPECTION CONVENTION
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TABLE OF CONTENTS Page INTRODUCTION 11 1 CHAPTER 1 - QUALITY MANAGEMENT 13 1.1 Principle 13 1.2 Quality Assurance 13 1.3 Good Manufacturing Practice for Medicinal products (GMP) 14 1.4 Quality Control 14 1.5 Product Quality Review 15 1.6 Quality Risk Management 16 2 CHAPTER 2 - PERSONNEL 17 2.1 Principle 17 2.2 General 17 2.3 Key Personnel 17 2 ...
[DOC File]Training Program
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EMPLOYEE GOOD MANUFACTURING PRACTICES. Personal Hygiene & Health Requirements. 1. All employees must wash their hands before starting work, after handling contaminated materials, breaks or lunch periods, and after using washroom facilities. Where necessary to minimize microbiological contamination, employees shall use disinfectant (hand dips). 2.
[DOC File]Note-To-File Template
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Oct 31, 2011 · Title: Note-To-File Template Author: Marlene Berro Last modified by: Office of Research Created Date: 11/5/2011 10:28:00 PM Company: UCSF Other titles
[DOC File]Company Dress Code & Personal Hygiene Policy
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If you have questions about these guidelines or a particular business areas dress requirements, contact your manager. Compliance. Departure from appropriate grooming, hygiene and attire standards will result in employee counseling and/or disciplinary action up to and including termination of employment.
[DOC File]Standard Operating Procedure (SOP)
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Standard Operating Procedure (SOP) Title Receiving of materials QA Signature Area Manager Signature Date of signature Date of signature Introduction: This document describes procedures to receive materials that will be stored in the warehouse.
[DOC File]The following are samples of documents used to build Good ...
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Sample GMP Documents . Sample HACCP Documents . A list of some Food Safety equipment suppliers used by companies in the 2007 – 2008 FSI Program in BC can be found here: Sources of Food Safety Equipment .pdf . A .zip file of all the above is here: Sample GMP and HACCP Docs.zip. Disclaimer:
[DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST
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Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks.
[DOC File]Надлежащая производственная практика
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EN ISO 9004-1 Quality management and quality system elements — Part 1: Guidelines (ISO 9004-1 : 1994) EN 46001 Quality systems — Medical devices — Particular requirements for the application of. EN 29001. EN 46002 Quality systems — Medical, devices — Particular requirements for …
[DOC File]Good Manufacturing Practices (GMP’s) Policy
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Good Manufacturing Practices (GMP’s) Policy The purpose of this policy is to ensure compliance with current Good Manufacturing Practice (GMP) regulations for foods. It is the responsibility of all involved personnel at every level of the organization to act immediately if a risk of violating this policy is detected.
[DOC File]European Commission | Choose your language | Choisir une ...
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This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use. Status of the document: Revision. Reasons for changes
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