In 2005, a small delegation (myself included) of the European Fine Chemicals Group (EFCG) met with the deputy head of the cabinet of Commissioner Kyprianou (the then Commissioner responsible for health and consumer protection). Our mission was simple - we were there to raise a red flag.
Today, approximately 1.5 million counterfeit medicine packs enter the legal supply chain each year - in other words, one pack in every 20000 is counterfeit.
Process steps, GMP documents, a purification vessel, and validation seem to disappear.
With a new head of the FDA expected to be announced imminently, the pharmaceutical industry waits to witness the changes that will inevitably accompany the new appointment. These changes could, however, also impact the rest of the world's pharmaceutical markets.
The author reviews the draft guidance on process validation, its QbD applications, and its potential impact on sterile manufacturing operations.
GMP agents report on old products, aseptic violations, and unexpected emotions.
Operational excellence awaits, but only if you can implement PAT successfully.
The source of a problem reveals itself after some investigation, or it may crash down on you.
When applied as part of a structured approach, predictive modelling can provide deep process and product understanding, and can enable true, continuous process validation as envisioned by ICH guidelines.
PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?
Enshrined in the concept of Quality by Design is the premise that optimized pharmaceutical manufacturing requires detailed understanding of products and processes. With this in mind, many benefits can be achieved by combining modern powder characterization techniques with real processing experience.
To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.
GMP experts act fast to resolve some unusual and difficult problems.
The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.
Readers give advice on their best approach to handling (batch) rejection
When accusations fly: 'Tis better to give than to receive.
How has pharmaceutical manufacturing validation influenced analytical instrument qualification during the last 20 years and what are the emerging trends for the future?
The closing date for comments to be received by the US Pharmacopeia (USP) for proposed revisions to Chapter <231>, which deals with analysis of heavy metals, is 15 December 2008. The USP has been working towards for approximately 4 years and the task has not been easy.
Production problems come in all shapes, sizes, and ... species.
During the past two decades, regulations have evolved in both Europe and the US to accommodate the technological developments in the pharmaceutical, biotechnology and medical device industries.
The US Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE), a not-for-profit organization comprising 11 universities, a $1.19 million contract to develop quality by design (QbD) guidance elements for design space and scale-up of unit operations.
To err may be human, but to really mess things up, you need management.
Cycle design and robustness testing using advanced process analytical technology.
The design of accurate and robust analytical methodology is instrumental to developing orally inhaled and nasal drug products (OINDPs) and their appropriate control programmes.
The biggest benefit that has been brought about by the compulsory labelling of allergens in food is the greater degree of cooperation that has been established between food manufacturers and their suppliers.
