spacer
home > epc > summer 2002 > tracking and audit trailing
PUBLICATIONS
European Pharmaceutical Contractor

Tracking and Audit Trailing

If an inspector wants to audit your facility tomorrow you will need to be able to prove that your staff have the ability and training to perform their job competently. This article highlights the regulatory pressure facing pharmaceutical companies and how management solutions can help.

Clearly, the financial rewards are great for those pharmaceutical companies that gain new insight into diseases and then develop wonder drugs that help arrest or treat them. But the regulatory requirements that govern the pharmaceutical industry are tight and growing tighter, and the need to manage compliance is crucial.

The impact of compliance is felt at every level - on drug substances and analytical research, on computer control systems and laboratory equipment, on Good Manufacturing Practice (GMP) operations and inspection techniques, and on documentation and people. And woe betide any organisation that fails to meet the standards. In the aftermath of a US$875 million settlement reached last Autumn between TAP Pharmaceutical Products and US federal prosecutors, pharmaceutical executives all over the world have been scrambling to understand how the bar has been raised for corporate compliance in their industry.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Mark Homer, Software Director at John Matchett Limited

Mark Homer is Software Director at John Matchett Limited (JML), having joined the company 14 years ago. He has been responsible for JML's software operation for the last 10 years. Mark has been involved in major projects for pharmaceutical organisations, helping them implement training automation and e-learning.

Other recent projects include the deployment of an e-learning infrastructure for a major car manufacturer and training and compliance systems for two major life organisations.

spacer
Mark Homer
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Innovative Micro-Infusion Pump for Gerresheimer Subsidiary Sensile Medical Developed and Successfully Launched for EVER Pharma

Düsseldorf/Olten, July 03, 2019 – Developed specially by Sensile Medical for EVER Pharma under the brand name D-mine®, this wearable microinfusion pump recently received European CE certification and has already been launched in several European countries. The compact, patient-friendly infusion pump is used for the continuous subcutaneous administration of drugs to treat Parkinson’s disease. The first micro pump from Gerresheimer subsidiary Sensile Medical to be available on the market, it gives Parkinson’s patients greater independence in their day-today lives.
More info >>

White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
More info >>

 
Industry Events

Nordic Life Science Days 10/12 September 2019

10-12 September 2019, Malmo Sweden

Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing together the best talents in Life Science, offering amazing networking and partnering opportunities, providing inputs and content on the most recent trends. Nordic Life Science Days attracts leading decision makers from the Life Science sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement