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9 October 2009 | By
A wide and versatile range of analytical techniques are routinely used, indeed are necessary, in pharmaceutical analysis. Over the past decade Raman spectroscopy has increasingly come to the fore as a valuable member of the arsenal of methods used, from both a fundamental and applied perspective, for the interrogation of…
In these economic times the pharmaceutical industry has expressed a renewed interest to explore ways in which to enhance the efficiency and agility of existing and future manufacturing processes. This is also true for laboratory-based operations that support forward processing and product release decisions. One function that can greatly benefit…
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…
Quality risk management (QRM) is an important part of science-based decision making which is essential for the quality management of pharmaceutical manufacturing1. The ICH Q9 guideline, Quality Risk Management2 defines QRM as a systematic process for the assessment, control, communication and review of risk to the quality of drug product…
7 February 2009 | By
Biotechnological expertise is becoming increasingly important within the pharmaceutical industry, and will play a pivotal role in the monitoring of fermentations, particularly their optimisation within the framework of Process Analytical Technologies (PAT). The ability to harness biological processes for the development of drug therapies, so called ‘biopharmaceuticals’ provides treatments that…
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…
2 August 2008 | By
Advanced Aseptic Processing (AAP) is a term referenced in the recently published ISPE RABS definition1 to cover the spectrum of Restricted Access Barrier Systems (RABS) and isolator systems. In general, AAP techniques are physical barrier methods of product protection and containment that are used during manufacturing operations to separate (primarily)…
19 June 2008 | By
Siemens seeks to deliver breakthrough innovations to give customers a unique competitive edge, in turn enabling societies to master their most vital challenges and creating sustainable value. Siemens was one of the first suppliers to adopt the new guidelines of the Food & Drug Administration (FDA) and the European Agency…
7 April 2008 | By
Since the FDA revolutionary white papers[1,2] in 2004, the industry has talked non-stop about the potential of PAT (Process Analytical Technology) and more recently, QbD (Quality by Design). These topics have found regular spots in conferences, press and internal company discussions. It has been widely stated3 that the benefits are…
7 April 2008 | By
Pharmaceutical analysis in drug development mainly focuses on methods to identify and quantify potential new drug candidates, determine purity, identify by – products and degradation products in compatibility and stability studies, and to determine the drug substance’s fate in the organism. Challenging tasks like these require sophisticated techniques, dedicated equipment…
23 January 2008 | By Stewart Green Director of Quality, Wyeth, UK and Chair, Pharmig
Arguably microbiology is the oldest of the applied sciences, although early exponents doubtless had no understanding of how the fruits of their labour in fermentation for example, came about. The true forerunners of microbiology as it is recognised today would be Koch, Pasteur, Petri et al, who developed much of…
23 January 2008 | By Hans H. Schicht, Dr. sc. Techn, Dr. Hans Schicht Ltd
There are many trends worth reporting in the context of pharmaceutical cleanroom technology: technical as well as regulatory trends. Supporting them is the continuing trend towards worldwide international standards, not only regarding contamination and biocontamination technology, but also regarding related topics such as air filtration. The endeavours for controlling micro-organisms,…
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…
23 November 2007 | By
Proper and compliant HVAC systems are fundamental to the pharma industry as we use high air change rates to secure a low viable and particle contamination. HVAC is energy consuming and therefore the HVAC accounts for a large proportion of the energy used in pharma facilities. In the past the…
21 September 2007 | By Karen Rossington, Marketing and Development Manager, Shield Medicare Ltd.
The manufacture of sterile pharmaceutical products is governed in the European Union by the requirements of EU Good Manufacturing Practice for Medicinal Products. The GMP guide gives very specific details on the environmental and microbial requirements for aseptic processing. However, little or no guidance is given on how to create…
