Category: Resource Type

Safety Features for Medicinal Products for Human Use Questions and Answers Version 12
This slide deck addresses Safety Features for Medicinal Products for Human Use (version 12) prepared by the European Commission Directorate-General [...]
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EU Annex 17 – Real Time Release and Parametric Release
Annex 17, Real Time Release Testing and Parametric Release, published by the European Commission, outlines the requirements for application of [...]
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Rx-360 Natural Disaster Contingency Planning
As we read the news around the world it almost seems that there is some sort of natural disaster occurring.  [...]
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EMA/CAT/80183/2014: Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy Medicinal Products (GTMP)
The EMA guideline on quality, non-clinical and clinical aspects of gene therapy medicinal products (GTMP´s) builds on earlier documentation and [...]
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PIC/S Guidelines on GDP of Active Substances for Medicinal Use
This document provides Pharmaceutical Inspection Convention Cooperation Scheme (PIC/S) Guidelines on the Principles of Good Distribution Practice of Active Substances [...]
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Data Integrity Library
This library is a collection of up to date publications associated with the topic of data governance and data integrity.  [...]
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Supplier Assessment Questionnaire Kit
Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual [...]
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ICH Q12 on Pharmaceutical Product Lifecycle Management was issued for public consultation
ICH Q12 Draft Guideline provides the framework to facilitate the management of post-approval CMC changes in a predictable and efficient [...]
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Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry
On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]
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Transition of ISO 13485 2003 to 2016
ISO 13485 is an internationally recognized quality management standard for organizations involved in the development, manufacture and distribution of medical [...]
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Pic/s Guidelines On The Principles Of Good Distribution Practice Of Active Substances For Medicinal Products…
These guidance’s are based on current Good Distribution Practices (GDP) for importers and providers of the distribution of active substances [...]
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PIC/S Guidelines on Excipient GMP Risk Assessment
The present PIC/S Guidelines is based on EC document 2015/C 95/02, and has been adopted by PIC/S as a guidance [...]
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Announcement on the Matters related to filing and Joint Review & Approval of Active Pharmaceutical…
The CNDA (formerly CFDA) has issued an announcement which clarifies the expectations for when excipient suppliers, API suppliers and packing [...]
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PIC/S GMP GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I
PIC/S has developed guides aimed at promoting the harmonization of GMP standards and guidance documents.  The PIC/S GMP Guides have [...]
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Taking a Collaborative Approach to Secure Donated Medicines
Providing and receiving donated medicines to populations in need through NGO partners can serve as a tremendous benefit to patients [...]
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Implementation of International Council for Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use…
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the [...]
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Annex 1 to the Good Manufacturing Practices Guide – Manufacture of Sterile Drugs (GUI-0119) Canada
Health Canada’s Annex 1 to the Good Manufacturing Practices Guide for Manufacture of Sterile Drugs (GUI-0119) will be implemented 01 [...]
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MHRA ‘GXP’ Data Integrity Guidance and Definitions
The MHRA published ‘GXP’ Data Integrity Guidance and Definitions in March 2018. The scope of this guidance is designated as ‘GXP’ [...]
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Guide: Best Practices for Quality Agreements Version 2.0
Quality Agreements (QAs) have become an essential tool to define quality and regulatory responsibilities between participants of the pharmaceutical supply [...]
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GMP Audit Manual – Data Governance and Data Integrity
This data integrity audit manual provides an approach for GMP auditing and self-assessment of pharmaceutical manufacturers, contract manufacturers and laboratories [...]
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GMP Guide for Drug Products GUI-001 Canada
This document offers guidelines for interpretation of Good Manufacturing Practices (GMP) as applied in Canada in order to comply with [...]
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EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS – VERSION 9
The European Commission Directorate-General for Health and Food Safety has prepared Question and Answers document to address questions regarding 2019 [...]
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Definitions of Suspect Product & Illegitimate Product for Verification Obligations Under the Drug Supply Chain…
The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act [...]
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FDA Unique Device Identification: Direct Marking of Devices
Unique Device Identification:  Direct Marking of Devices is a guidance document issued by the FDA on 17 November 2017 to [...]
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FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
On November 27, 2017, FDA issued a draft guidance to help trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) understand their compliance [...]
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Annex 1 on Manufacturing of Sterile Medicinal Products, of the Eudralex Volume 4
Annex 1 “Manufacturing Of Sterile Medicinal Products” of the EU GMP Guide was first published in 1971, since then it [...]
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EU SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE QUESTIONS AND ANSWERS VERSION 8
The European Commission Directorate-General for Health and Food Safety has prepared Question and Answers document to address questions regarding 2019 [...]
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EMA Guideline on Manufacture of the Finished Dosage Form
The purpose of this guidance is to provide clarification on the type and level of information to be included in [...]
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Integrating a Third Party Audit Provider into an Existing Supplier Quality Management Process
The increase in requirements and expectations from both Regulators and Customers has challenged the Pharmaceutical Industry to maintain sufficient oversite [...]
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Quality Elements for Suppliers of Products or Services to GMP Regulated – Spanish Version
Los Elementos de Calidad para los proveedores de productos o servicios que proveen a empresas reguladas por las Buenas Prácticas [...]
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Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry…
FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities.  [...]
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EMA Implementation plan for the introduction of the safety features on the packaging of centrally…
New legislative requirements from the European Medicines Agency and the European Commission, specifically the new Commission Delegated Regulation (EU) 2016/161) [...]
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Rx-360 Quality Elements for Suppliers of Products or Services to GMP Regulated Companies
Quality Elements for Suppliers of Products or Services to GMP Regulated Companies outlines the basic GMP elements expected of suppliers [...]
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Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013. Section 202 of the DSCSA [...]
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CANADA GAZETTE – Regulations Amending the Food and Drug Regulations (Importation of Drugs for an…
The objective of the regulatory amendments is to enable access to drugs that would help address an urgent public health [...]
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European Commission – Safety Features for Medicinal Products for Human Use – Q&A version 7
The European Commission provided an update to the Questions and Answers regarding “Safety Features For Medicinal Products For Human”.  This [...]
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FDA – Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA)
Enhanced drug distribution security needs September 22, 20172 December 5-6, 2017 9:00am to 4:00pm EST   (Advance Registration: October 2-27, [...]
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Regulation (EU) 2017/746 of the European Parliament & Council of 4/5/17 on in vitro diagnostic…
The European regulations governing in vitro diagnostic devices have recently been updated, and enter into force on 26 May 2022 [...]
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MHRA GMP Inspection Deficiency Data Trend 2016
The MHRA has improved the way of gathering the inspection deficiency data for 2016. The new data trending can allow [...]
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FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
On December 9, 2016, FDA issued guidance for industry entitled ‘‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product [...]
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EMA Implementation Strategy of ICH Q3D Guideline
On 08 March 2017, EMA issued an implementation strategy of the ICH Q3D guideline that addresses specific considerations to enable [...]
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EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents
On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline [...]
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Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA [...]
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Agreement on Mutual Recognition Between EU Community and US FDA
The US FDA and the EU announced that they have completed an exchange of letters to amend the Pharmaceutical Annex [...]
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Working Group Adds New Resources to Data Integrity Library
The Data Integrity Working Group has added four additional resources (links below) to the Data Integrity Library. We welcome you [...]
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Cargo Theft in the Pharmaceutical Industry – What Does it Really Cost?
Introduction Most modern pharmaceutical supply chains are complex, global, outsourced, and decentralized. In addition, many supply chains are vulnerable to [...]
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Upstream Supply Chain Mapping
Introduction:  This white paper reviews the present state of how the pharmaceutical industry maps its upstream raw material supply chain [...]
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Upstream Supply Chain Security Risk Assessment Tool
About: This tool has been developed in excel document: Tab 1:Cause and Effect Matrix Tab 2: Failure Mode and Effects [...]
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Supply Chain Mapping Spreadsheet
About: This tool allows you to map your supply chain. The template has been developed in word document so that [...]
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Upstream Supply Chain Security
Purpose and Scope: This white paper reviews the present state, current challenges, and recommended best practices for several upstream supply [...]
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Counterfeit, Unapproved and Diverted Drugs Threats & Monitoring Process
Introduction and Overview: The distribution and sales of Counterfeit, Unapproved and Diverted Drugs (CUDD) are a global concern for pharmaceutical [...]
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