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ICH guidelines

 

Francisca Gouveia, 4Tune Engineering Ltd
Francisca Gouveia, 4Tune Engineering Ltd
article

Pharma development and manufacturing with QbD 2.0

3 July 2014 | By José Menezes, Institute of Biotechnology and Bioenginerring, IST, Universidade de Lisboa / Francisca Gouveia and Pedro Felizardo, 4Tune Engineering Ltd

Pharma and BioPharma industries are aware of the impact of production processes on sustainability of business operations. To improve performance, companies have recognised that it is necessary to better understand the drivers of both costs and revenues and the actions that can be put in place to address them.

Foreword: ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
Foreword: ICH Q6A - Specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances
article

ICH Q6A specifications: Test procedures and acceptance criteria for new drug substances and new drug products: chemical substances

15 December 2013 | By

Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use.’ The guidance is sub-divided into universal tests applicable…

Dave Elder ICH guidance author
Dave Elder ICH guidance author
article

ICH Q3D: Metal Impurities: A Critical Evaluation

22 October 2013 | By David Elder, JPAG and GlaxoSmithKline / Andrew Teasdale, JPAG chairman and AstraZeneca

Historically, control over metal impurities has been achieved via pharmacopoeial heavy metals limit tests, e.g. United States Pharmacopeia (USP) .

David P. Elder
David P. Elder
article

ICHQ2(R1) Validation of Analytical Procedures – Challenges and Opportunities

20 August 2013 | By

The International Conference on Harmonisation (ICH) guideline for the Validation of Analytical Procedures (ICHQ2(R1)) currently covers validation procedures for the four most common analytical tests: identification tests, quantitative tests for impurities, limit tests for the control of impurities and quantitative tests for the active moiety(ies) in APIs (active pharmaceutical ingredients)…

A pragmatic approach for the adoption of QbD principles for analytical method development and validation
A pragmatic approach for the adoption of QbD principles for analytical method development and validation
article

A pragmatic approach for the adoption of QbD principles for analytical method development and validation

18 April 2013 | By Heike Gottschalg, Rüdiger Gössl, Holger Memmesheimer and Holger-Thorsten Steinführer, Boehringer Ingelheim Pharma GmbH & Co KG

The principles of the application of Quality by Design (QbD) in the pharmaceutical industry in terms of development, manufacturing and control are well defined and described in the ICH guidelines Q8, Q9 and Q10. These guidelines mainly focus on the quality of the drug products, their manufacturing processes and the…

P{ills and tablets
P{ills and tablets
article

QbD and PAT: From Science to Compliance

30 July 2009 | By Pedro E. Hernandez-Abad, Associate Director; Jun Huang, Principal PAT Scientist II and Saly Romero-Torres, Principal PAT Scientist, both Wyeth Pharmaceuticals

Boards of health like the Food and Drug Administration and European Medicines Agency and ICH guidelines Q8, Q9 and Q10, provide a framework for Quality by Design (QbD) that fully integrates drug substance and drug product development with the principles of Quality Risk Management (QRM), Process Analytical Technology (PAT) and…

Pills and tablets
Pills and tablets
article

PAT Initiative review 2008

10 January 2009 | By Martin Warman, Director, MWC Ltd

As the industry approaches the five year anniversary of the ground breaking regulator initiatives (the ‘PAT framework' and ‘cGMPs for the 21st Century'1,2), it is time to assess the impact they have had on the industry and to look forward to what the industry may look like in another five…

Purple pills, tablets
Purple pills, tablets
article

Successful Process Analytical Technology (PAT) implementation in pharmaceutical manufacturing

29 September 2008 | By Thirunellai G. Venkateshwaran (Senior Director, New Products Quality, Global Quality and Compliance), John Levins (Senior Director, Technology Transfer & Process Innovation) and Stephen P. Simmons (Head of New Product Quality and Quality by Design), all Wyeth Pharmaceuticals

The use of Process Analytical Technology (PAT) while a relatively new concept to the Pharmaceutical Industry has been a tried and tested concept in the petrochemical industry for many years. The adaptation of PAT systems by the Pharmaceutical Industry was accelerated by the recent initiatives of the regulatory authorities globally…

The scope of Process Analytical Technology (PAT) in real-time advanced control of tablet quality
The scope of Process Analytical Technology (PAT) in real-time advanced control of tablet quality
article

Wyeth’s PAT variations submitted through the EMEA Worksharing Procedure

19 June 2008 | By Graham Cook PhD, Senior Director, Process Knowledge/Quality by Design, Wyeth Pharmaceuticals

In June 2006, the EMEA called for nominations from companies to participate in the pilot phase of a worksharing exercise for Quality variations1. Worksharing is a key element in the revisions to the variations proposed by the European Commission, which are intended to streamline the process for making changes to…

Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
Figure 2: PQLI Criticality Decision Tree to Delineate Categories and Levels of Criticality Across the Product Lifecycle (NOR = Normal Operating Range PAR = Proven Acceptable Range CpK = Measure of process robustness PAT = Process Analytical Technology)
article

Product Quality Lifecycle Implementation (PQLI) – providing practical solutions

23 January 2008 | By

This article discusses ISPE’s Product Quality Lifecycle Implementation (PQLI) initiative, which is to provide practical guidance for implementation of ICH Q8, Q9 and Q10. It represents the author’s individual opinion. It should be noted that PQLI is an evolving work area and so will continue to develop beyond the position…

Pharma Webinar: Navigating the Complexities of Pharmaceutical Manufacturing Regulations
Pharma Webinar: Navigating the Complexities of Pharmaceutical Manufacturing Regulations
article

The future direction of ASTM E55 Committee on manufacture of pharmaceutical products

23 November 2007 | By Steve Simmons, Head of Process Knowledge QbD, Wyeth Pharmaceuticals

ASTM Committee E55 formed in April of 2003 as a result of FDA’s GMPs for the 21st Century Initiative and the subsequent Guidance, “PAT – a framework for innovative pharmaceutical manufacturing and quality assurance.” Focusing on process understanding and flexible manufacturing, FDA encouraged the pharmaceutical industry to utilise the consensus…