Picscheme.org

INSPECTION OF HEALTH BASED EXPOSURE LIMIT …

WebSCOPE. 4.1 This aide-memoire incorporates inspection of the HBEL assessment report as well as the Quality Risk Management (QRM) assessment for cross contamination …

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URL: https://picscheme.org/docview/1947

GUIDELINE ON SETTING HEALTH BASED EXPOSURE …

WebA A factor of individuals. 10 to account for variability between. F3: A factor 10 to account for repeat-dose toxicity studies of short duration, i.e., less than 4-weeks. F4: A factor (1-10) …

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CROSS-CONTAMINATION IN SHARED FACILITIES

WebThe cross-contamination risk management system must clearly link to the protection of the patient and/or target animals. 2.4.1 The evaluation of the hazards presented by the …

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PIC/S GUIDANCE ON CLASSIFICATION OF GMP …

WebDOCUMENT HISTORY. Adoption by Committee of PI 040-1 25 September 2018. Entry into force of PI 040-1. 1 January 2019. 2. INTRODUCTION. 2.1 This guidance is intended to …

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GUIDE TO GOOD MANUFACTURING PRACTICE FOR …

WebTable of contents PE 009-17 (Annexes) -iii- 25 August 2023 Starting materials 142 Quality control 145 Annex 6 (Manufacture of medicinal gases) 146 Principle 146 Manufacture of …

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PHARMACEUTICAL INSPECTION CONVENTION …

Webe-mail:[email protected]. web site: https://www.picscheme.org. Introduction. PE 009-17 (Intro) 25 August 2023. INTRODUCTION. General. In order to further facilitate the …

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PE 010-4 Guide to Good Practices for the Preparation …

WebPE 010-4 7 of 56 1 March 2014 11. Deviation report A deviation report is a report of any deviation from standard procedures and documentation that occurs during the …

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PROCEDURE FOR HANDLING RAPID ALERTS AND …

Web2.5 In the present document a Competent Authority means a National Medicines Regulatory Authority, which is covered by a bilateral or a multilateral agreement such as the PIC/S …

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PI 006-3 Recommendation on Validation Master Plan

WebON. PI 006-3 25 September 2007. VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING …

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Publication of revised PIC/S Annex 1

WebThe Department of Health and the Pharmacy and Poisons Board of Hong Kong (PPBHK) hosted the 6th PIC/S Expert Circle Meeting on Good Distribution Practice (GDP) from 29 …

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PICS Audit Checklist

WebPS/W 31/2019 2 of 57 1 September 2020 MRA/JAP/PIC/S Audit Checklist* - Interpretation guide Purpose The interpretations provided in this guide have been written with a view to …

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GUIDANCE ON PARAMETRIC RELEASE

WebIn addition the document provides a framework for GMP inspectors and Marketing Authorisation assessors to work together and jointly approve an application for …

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PHARMACEUTICAL INSPECTION CONVENTION …

Web5 BMG and ZLG count as one Participating Authority. All German Medicinal Authorities, which are listed on the ZLG web site, are considered as PIC/S Participating …

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