Process and Scaling

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.

Operators are hit hard by breakage problems and strike out on FDA inspections.

The challenges of ineffective quality monitoring of complaints, investigations and adverse event reporting can lead to patient harm or death, product withdrawal, and negative financial and brand impact to the organization.

...some companies complained that what they received was not joint advice or combined advice but parallel advice, without coherence...

All commercial sponsors want to maximize their profit and, with a population close to 500 million, the EU is an enormous potential marketplace that they simply cannot ignore!

The pharmaceutical industry is facing the perfect storm. Increasing healthcare costs, a changing regulatory environment and vigorous global competition coupled with the increasing complexity of small molecule and biotech drugs contributing to expensive discovery processes and clinical trials, as well as the resultant manufacturing challenges, all pose major threats to the industry.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

They may have seemed harmless at first, but these ideas took a big bite.

At first glance, the title of this article may bring a wry smile to the face of many an astute practitioner, but I can provide 'documentary evidence' that free validation is not a just a play on words, but a financial reality.

How can any company be sure that the standards that suppliers might claim to operate, and might be able to demonstrate from time to time, are actually being practised all the time?

Customers complaining lead to some serious explaining.

WFI system deficiencies and damp tax records cause problems for two plants

The assembly of the World Health Organisation (WHO) later this month is expected to feature counterfeit medicines as one of its important discussion points, and there is some hope that the ministers will agree on measures that will strengthen anticounterfeiting legislation and enforcement worldwide.

When Pharmaceutical Technology Europe was established 20 years ago, PAT was not a hot topic in the industry. It was started in 2002 by FDA to modernize pharmaceutical manufacturing and increase the efficiency of manufacturing processes.

Practical guidance on how to handle validation failures cannot be found in the existing literature because they are not supposed to happen.