Introduction to ICH - - The Quality Guidelines The Quality Guidelines

The “Q-Family”

Q 1 – Stability Testing

Q 2 – Analytical Validation

Q 3 – Impurities

Q 4 – Pharmacopoeias

Q 5 – Biotechnological Products

Q 6 – Specifications

Q 7 – Good Manufacturing Practices

Q 8 – Pharmaceutical Development

Q 9 – Quality Risk Management

Q 10 – Pharmaceutical Quality System

 

ICH Q 1 – Stability Testing

A set of originally five guidelines (Q1A to Q1F)

defining

- General aspects of stability testing (storage

conditions, batch size and number, length of

time...)

- Photostability

- Application to new dosage forms

- Possibilities for reduced test designs

(bracketing and matrixing)

Dr. Susanne Keitel, 12/08

©2008 EDQM, Council of Europe, All rights reserved

 

I

ICH Q 1 – Stability Testing

- Statistical evaluation of stability data

and possibilities for extrapolation

- Storage conditions for stability testing in

climatic zones III and IV (withdrawn

 

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INDEX OF PHARMACOPOEIAS

INDEX OF PHARMACOPOEIAS

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WHO good manufacturing practices

Production

Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.

WHO good manufacturing practices

• Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
  pdf, 5.51Mb
  Volume 2, 2nd updated edition
• WHO good manufacturing practices: main principles for pharmaceutical products
  pdf, 278kb
  Annex 3, WHO Technical Report Series 961, 2011
• Frequently Asked Questions: Good Manufacturing Practice (GMP) in Pharmaceutical Practice
• Active pharmaceutical ingredients (bulk drug substances)
  pdf, 206kb
  Annex 2, WHO Technical Report Series 957, 2010
• Pharmaceutical excipients [pdf 7Mb]
  pdf, 1.02Mb
  Annex 5, WHO Technical Report Series 885, 1999
• WHO good manufacturing practices for sterile pharmaceutical products
  pdf, 171kb
  Annex 6, WHO Technical Report Series 961, 2011
• Biological products
  pdf, 549kb
  Annex 3, WHO Technical Report Series 822, 1992
• WHO good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization)
  pdf, 322kb
  Annex 4, WHO Technical Report Series 961, 2011
• Pharmaceutical products containing hazardous substances
  pdf, 146kb
  Annex 3 WHO Technical Report Series 957, 2010
• Investigational pharmaceutical products for clinical trials in humans [pdf 4Mb]
  pdf, 564kb
  Annex 7, WHO Technical Report Series 863, 1996
• Herbal medicinal products
  pdf, 119kb
  Annex 3, WHO Technical Report Series 937, 2006
• Radiopharmaceutical products
  pdf, 95kb
  Annex 3, WHO Technical Report Series 908, 2003
• Water for pharmaceutical use
  pdf, 329kb
  Annex 2, WHO Technical Report Series 970, 2012
• WHO guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
  pdf, 396kb
  Annex 5, WHO Technical Report Series 961, 2011
• Validation
  pdf, 272kb
  Annex 4, WHO Technical Report Series 937, 2006

Risk analysis

• Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
  pdf, 103kb
  Annex 7, WHO Technical Report Series 908, 2003

Technology transfer

• WHO guidelines on transfer of technology in pharmaceutical manufacturing
  pdf, 156kb
  Annex 7, WHO Technical Report Series 961, 2011

Training materials

• WHO Basic Training Modules on GMP
  (Includes an introduction, resource and study pack for trainers)

• WHO supplementary training modules on GMP
  (Includes drafts of GMP for Validation, Water, and Air Handling Systems)

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WHO Guideline Vitamin A supplementation in pregnant women

World Health Organization

Publication details

Number of pages: 30
Publication date: 2011
Languages: Arabic, Chinese, English, French, Russian, Spanish
ISBN: 978 92 4 150178 1

Downloads

• Summary English
  pdf, 55kb
• Full text

Overview

This guideline provides global, evidence-informed recommendations on the use of vitamin A supplements in pregnant women for the prevention of morbidity, mortality and night blindness in populations where vitamin A deficiency may be a public health concern.
These recommendations will help Member States and their partners in their efforts to make informed decisions on the appropriate nutrition actions to achieve the Millennium Development Goals, in particular, improvement of maternal health (MDG 5). The guideline is intended for a wide audience including policy-makers, their expert advisers, and technical and programme staff in organizations involved in the design, implementation and scaling-up of nutrition actions for public health.

Source

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EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

Introduction

• Introduction(33 KB) (7/02/2011)
• Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
  Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
• Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Part I - Basic Requirements for Medicinal Products

• Chapter 1 Pharmaceutical Quality System (65 KB)(Deadline for coming into operation: 31 January 2013)
  Chapter 1 Quality Management (revision February 2008)(29 KB)
• Chapter 2 Personnel(20 KB)
• Chapter 3 Premise and Equipment(34 KB)
• Chapter 4 Documentation (Revision January 2011) - Coming into operation by 30 June 2011(33 KB)NEW
• Chapter 5 Production(50 KB)
• Chapter 6 Quality Control (33 KB)
• Chapter 7 on Outsourced activities(21 KB) (Deadline for coming into operation: 31 January 2013)
  Chapter 7 Contract Manufacture and Analysis(22 KB)
• Chapter 8 Complaints and Product Recall (18 KB)
• Chapter 9 Self Inspection(11 KB)

Part II - Basic Requirements for Active Substances used as Starting Materials

• Basic requirements for active substances used as starting materials(452 KB)

 Part III - GMP related documents 

• Site Master File (33 KB)
• Q9 Quality Risk Management
• Q10 Note for Guidance on Pharmaceutical Quality System
• MRA Batch Certificate(101 KB)
• Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (487 KB)(Version 2, January 2013)

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EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

Introduction

• Introduction(33 KB) (7/02/2011)
• Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
  Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
• Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Part I - Basic Requirements for Medicinal Products

• Chapter 1 Pharmaceutical Quality System (65 KB)(Deadline for coming into operation: 31 January 2013)
  Chapter 1 Quality Management (revision February 2008)(29 KB)
• Chapter 2 Personnel(20 KB)
• Chapter 3 Premise and Equipment(34 KB)
• Chapter 4 Documentation (Revision January 2011) - Coming into operation by 30 June 2011(33 KB)NEW
• Chapter 5 Production(50 KB)
• Chapter 6 Quality Control (33 KB)
• Chapter 7 on Outsourced activities(21 KB) (Deadline for coming into operation: 31 January 2013)
  Chapter 7 Contract Manufacture and Analysis(22 KB)
• Chapter 8 Complaints and Product Recall (18 KB)
• Chapter 9 Self Inspection(11 KB)

Part II - Basic Requirements for Active Substances used as Starting Materials

• Basic requirements for active substances used as starting materials(452 KB)

 Part III - GMP related documents 

• Site Master File (33 KB)
• Q9 Quality Risk Management
• Q10 Note for Guidance on Pharmaceutical Quality System
• MRA Batch Certificate(101 KB)
• Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use (487 KB)(Version 2, January 2013)

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Environment Directorate-General

The Directorate-General for the Environment is one of the more than 40 Directorates-General and services that make up the European Commission. Commonly referred to as DG Environment, the objective of the Directorate-General is to protect, preserve and improve the environment for present and future generations. To achieve this it proposes policies that ensure a high level of environmental protection in the European Union and that preserve the quality of life of EU citizens.

The DG makes sure that Member States correctly apply EU environmental law. In doing so it investigates complaints made by citizens and non-governmental organisations and can take legal action if it is deems that EU law has been infringed. In certain cases DG Environment represents the European Union in environmental matters at international meetings such as the United Nations Convention on Biodiversity.

The DG also finances projects that contribute to environmental protection in the EU. Since 1992 some 2,600 projects have received some financing from LIFE, the EU's financial instrument for the environment.

• Proposal for a new general Union Environment Action Programme to 2020
  

Every year the Directorate General makes public its priorities for the upcoming year and also publishes a yearly report on the preceding year's policy initiatives. 

• DG Environment Factsheet
• Organisation chart of the Directorate General for the Environment
• DG Environment Management Plan for 2013 (pdf ~1,2M)
• Communication Strategy 2013 (pdf ~11K)
• Indicative list of publications 2012 (pdf ~63K)
• Indicative list of events in 2012 (pdf ~11K)
• Environmental Policies in Member States
• Environment within the Strategic Objectives and Annual Work Programme of the European Commission
• Evaluating environmental policy

Improving environmental management at the European Commission

Since 2002 DG Environment and four other Commission services (OIB, DG HR, DIGIT and SG) have taken part in a pilot project to improve the Commission's environmental performance through  the implementation of an environmental management system in line with the EMAS  regulation . From 2002 to 2008, electricity and water consumption have gone down by 14 and 22% respectively. Emissions of CO2 have also decreased (7%) and so has the amount of waste generated (11%). By mid-2008 nearly half of Commission staff used public transport such as busses, trams, metro or the train. Following the positive results of this pilot phase it was decided to extend  the EMAS  system  to the whole Commission, starting in January 2010.

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European Commission Departments (Directorates-General) and services

The Commission is divided into several departments and services. The departments are known as Directorates-General (DGs).

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EudraLex

EudraLex is the collection of rules and regulations governing medicinal products in the European Union.

Volumes

EudraLex consists of 10 volumes:

• Concerning Medicinal Products for Human use:
  • Volume 1 - Pharmaceutical Legislation.
  • Volume 2 - Notice to Applicants.
    • Volume 2A deals with procedures for marketing authorisation.
    • Volume 2B deals with the presentation and content of the application dossier.
    • Volume 2C deals with Guidelines.
  • Volume 3 - Guidelines.

• Concerning Medicinal Products for human use in clinical trials (investigational medicinal products).
  • Volume 10 - Clinical trials.

• Concerning Veterinary Medicinal Products:
  • Volume 5 - Pharmaceutical Legislation.
  • Volume 6 - Notice to Applicants.
  • Volume 7 - Guidelines.
  • Volume 8 - Maximum residue limits.

• Concerning Medicinal Products for Human and Veterinary use:
  • Volume 4 - Good Manufacturing Practices.
  • Volume 9 - Pharmacovigilance.

• Miscellaneous:
  • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)

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About European Commission, History and Establishment

The European Commission (EC) is the executive body of the European Union responsible for proposing legislation, implementing decisions, upholding the Union's treaties and day-to-day running of the EU.

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