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

QUESTIONS AND ANSWERS ON IMPLEMENTATION OF RISK …

WEBPI 053-1 3 of 7 1 June 2020 3. SCOPE 3.1 The scope of the present guideline is to support the PIC/S Guideline on setting health-based exposure limits for use in risk identification in the manufacture of

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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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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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GOOD PRACTICES FOR DATA MANAGEMENT AND …

WEB9.1.9 The guidance herein is intended to provide specific considerations for data integrity in the context of computerised systems. Further guidance regarding good practices for …

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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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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 …

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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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PHARMACEUTICAL INSPECTION CONVENTION …

WEBOriginally, the PIC/S GMP Guide (“PIC Basic Standards” of 1972) derives from the WHO GMP Guide and was further developed in order to comply with stringent manufacturing …

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GUIDE TO GOOD MANUFACTURING PRACTICE FOR …

WEBTable of contents PE 009 -17 (Annexes) i-25 August 2023 ANNEXES Annex 1 (Manufacture of sterile medicinal products) 1 Document map 1 Scope 2 Principle 2 …

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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 RECALLS …

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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