GUIDANCE ON ASPECTS OF CLEANING ... - …

confidential 1 revision september 2016 active pharmaceutical ingredients committee (apic) guidance on aspects of cleaning validation in …

  Pharmaceutical, Active, Ingredients, Committees, Apic, Active pharmaceutical ingredients committee

ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE …

- Stefaan Van De Velde, Ajinomoto Bio-Pharma Services, Belgium A revision of the guidance document was done in 2016 to bring it in line with the European Medicines Agency Guidance on use of Health Based data on setting health-based exposure limits for determining safe threshold values for the cleaning1. The main changes were

  Pharmaceutical, Active, Ingredients, Committees, Active pharmaceutical ingredients committee, Pharma

Guidance on Handling of Insoluble Matter and …

APIC Guidance on Insoluble Matter and Foreign Particles in APIs Page 3 of 19 Table of contents 1. Acknowledgements 2. Introduction and Purpose

ACTIVE PHARMACEUTICAL INGREDIENTS …

APIC_eCTD How to Do Page 4 INTRODUCTION eCTD is a topic of increasing interest in the pharmaceutical environment. In the past, the main focus for regulatory authorities was eCTD submissions sent via MAAs.

  Pharmaceutical, Active, Ingredients, Active pharmaceutical ingredients, Apic

GUIDELINE for QUALIFICATION & MANAGEMENT …

active pharmaceutical ingredients committee (apic) guideline for qualification & management of contract quality control laboratories 10 january 2012

  Management, Contract

Quality Management System - apic.cefic.org

Quality Management System (QMS) for Active Pharmaceutical Ingredients (API) Manufacturers integrating GMP (ICH Q7a) into ISO (9001: 2000) September 2005

  System, Pharmaceutical, Management, Quality, Quality management system

Registered Starting Material Auditing Guide - …

AIDE MEMOIRE FOR REGISTERED STARTING MATERIAL AUDITS 1) APIC Guide for Auditing Registered Starting Material Manufacturers * tbi = to be implemented Page 2 / 23 ** Procedure, SOP, OI, memo, notes (personal), Q-manual

  Auditing

Quality Agreement for Laboratories Guideline Templates

A Quality Agreement under the scope of this guideline is a legally binding agreement that is mutually negotiated and concluded between (the Quality Departments of) the service requestor and the Quality responsible at the service providing laboratory.

  Laboratory, Agreement

“How to do” Document

The explanatory notes in this guide are the views of The Active Pharmaceutical Ingredients Commit- tee (APIC) and not necessarily those of the European Commission or WHO. This document does not intend to provide an exhaustive list of how to comply with the require-

  Notes, Pharmaceutical, Document, Explanatory notes, Explanatory, How to do document

Practical risk-based guide for managing data integrity

Assign GxP data to a specific category based on a . severity assessment (refer to section 4.1) Create a . profile. of each . system. based on the way GxP data is handled by that system (e.g. data generation, storage, processing, transfer or a combination thereof) and assign a category to the system based on its profile; (refer to section 4.2)

  Based, Managing

GUIDANCE ON ASPECTS OF CLEANING …

confidential 1 revision september 2016 active pharmaceutical ingredients committee (apic) guidance on aspects of cleaning validation in active pharmaceutical ingredient plants

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Quality Management systems - Process Validation …

GHTF Study Group 3 - Quality Management Systems Process Validation Guidance – January 2004 Page 2 Process Validation Guidance Contents 0 Introduction

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Scottish Dental cep Clinical Effectiveness Programme

Cleaning of Dental Instruments Dental Clinical Guidance Second Edition The Scottish Dental Clinical Effectiveness Programme (SDCEP) is an

  Guidance, Clinical, Programme, Effectiveness, Cleaning, Clinical effectiveness programme

Annex 4 Supplementary guidelines on good …

109 turers. It is not the intention to be prescriptive in specifi c validation require-ments. This document serves as general guidance only, and the principles

  Guidelines, Good, Validation, Guidance, Supplementary guidelines on good, Supplementary

Validation of Production Processes for Vaccines for …

Validation of Production Processes for Vaccines for WHO Prequalification- Compliance Expectations A note for guidance for the manufacture of …

  Validation, Guidance, Compliance, Prequalifications, Expectations, For who prequalification compliance expectations

STERILIZATION VALIDATION - WuXi AppTec

STERILIZATION VALIDATION WuXi AppTec H-3 EO STERILIZATION VALIDATION DETERMINATION OF BIOBURDEN For more information on …

  Validation, Sterilization, Sterilization validation