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[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.
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[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. ... Whenever parts and tools are stored in the production area, they should be ...
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[DOC File]COMPETENCY BASED CURRICULUM - TESDA
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Awareness of Codes or Regulations such as HACCP and GMP. Preparing sampling tools and equipment. Using PPE. CONDITIONS: The trainees/students must be provided with the following: References on sampling requirement and plan . References on HACCP and GMP. Sampling materials, tools and equipment. PPE. Notebook and pen. METHODOLOGIES: Lecture ...
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[DOC File]Outside Contractor Policy
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All contractors must have clean and sanitary tools and clothing. All company . GMP’s. and . HACCP. rules must be followed! All contractors must read over the company . Glass Policy. Lock all tools and parts in toolboxes/cases/pouches when you are not using them. All work areas must be clearly marked by caution tape or any other visible method.
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[DOC File]GMP inspection report - community format
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The Community format for a GMP inspection report has been established in accordance with Art. 47 of Directive 2004/27/EC and Art. 51 of Directive 2004/28/EC amending Directives 2001/83/EC and 2001/82/EC respectively.
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[DOC File]Validation, Verification, and Testing Plan Template
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3.x.6 Testing Tools. Identify the testing tools to be used during the preparation for and execution of the test. 3.x.7 Site Supplied Materials. Describe any materials required to perform the test that need to be supplied at the test site. These materials could include desks, chairs, special equipment, office supplies, database and its media, as ...
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[DOC File]Risk Assessment Tool
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ACME Corporation Compliance Risk Assessment. Purpose: Companies that implement best-in-class compliance programs engage in the regular and systematic identification and assessment of risks.
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[DOC File]New Chapter 8 of GMP guide for consultation
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8.12 The decisions that are made during and following quality defect investigations should reflect the level of risk that is presented by the quality defect as well as the seriousness of any non-compliance with respect to the requirements of the marketing authorisation/ product specification file or GMP.
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[DOC File]USER REQUIREMENTS TEMPLATE - PHARM COMMUNITY
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9.2 Tools 20. 9.3 Spare Parts 21. 10.0 Life-Cycle 21. 10.1 Development 21. 10.2 Testing 22. 10.3 Delivery 22. 10.4 Documentation 22. 10.5 Support 23. 11.0 Glossary 25. 12.0 References 26. 13.0 Approval 27 REVISION HISTORY. Rev. Date Approval Revision Summary A0 02/25/03 TGP Initial Draft A1 5/20/03 LM Comments from Terry Petro A2 8/22/03 TGP ...
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[DOCX File]CMGC White Paper
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Guaranteed Maximum Price (GMP) Introduction Under traditional design-bid-build (DBB) contracting, contractual price is reached through a competitive bidding environment, with the selected contractor being the bidder with the lowest price that is able to meet other contractual obligations such as bonding and insurance requirements.
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