spacer
home > ebr > winter 2018 > warning letters
PUBLICATIONS
European Biopharmaceutical Review

Warning Letters

Over the years, communication in the form of published warning letters mentioning requirements for particle characterisation from the FDA has increased. They raise awareness of the control of particle properties of active pharmaceutical ingredients (API) and excipients in manufacturing and the final product (1). Among the wide range of properties that shall be tested, the ICH guidelines topics Q6A and Q8 exemplify particle size, water content, solubility and crystal properties (2). However, they do not seem to be in place everywhere at ingredient suppliers and medicine manufacturers, as underlined by the FDA warning letters. By law, the possibility to carry out validated and approved analysis methods need to be ready before the start of routine production, but may already prove essential in early developing phases. These are needed to set meaningful specifications and later control the out-ofspecification (OOS) in-processes.

Thorough screening and the use of correlated methods ensure the suitable specifications for the solid form, be it organic or biological. Highlighted in this article are the effects of particle properties on manufacturability (flow, size control, general handling), pharmaceutical window distortion (by shift in size distribution and dissolution) and patient safety. This information is very helpful for maintaining control over the manufacturing process. .

In the past five years, FDA warning letters referring to particle characterisation numbered between one and three, but, in the first three quarters of 2017, four had already been sent out. On the basis of ICH guidelines, these intercept the possibility of the manufacturer or resell to import or sell specific products in the regulatory region issuing the letter: the US, which is the most important pharma market today.

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
Søren Lund Kristensen is the founder and Chief Executive Officer at Particle Analytical, a Danish FDA- and DKMA-approved analysis company operating under cGMP standards for primarily pharma customers worldwide. He is an advisory board member for the Technical University of Denmark. Søren received his education from Royal Veterinary and Agricultural University (now Copenhagen University), Denmark.

Dr Harm Otten is a chemist working at Particle Analytical on a project basis. He received his education from Philipps University, Marburg, Germany and Copenhagen University, Denmark.

spacer
Søren Lund Kristensen
spacer
spacer
spacer
Dr Harm Otten
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Denny Bros Group continues its support of Packaging Innovations

A world leading print company is preparing to showcase its renowned labelling and printing solutions at next month’s prestigious Packaging Innovations show.
More info >>

White Papers

Sterile Vials Made of Tubular Glass

Gerresheimer AG

Gx® RTF vials powered by Ompi EZ-fill® enhance flexibility by facilitating packaging needs from clinical stage to industrialization with the common goal to minimize customer product risks and optimize total cost of ownership. Gerresheimer combines the competencies in converting glass tubes to serum/ injection vials and ready-to-fill processing for our pharma and biotech customers.
More info >>

 
Industry Events

4th Annual Formulation & Drug Delivery Congress

8-9 May 2018, London, UK

Oxford Global are proud to present our hugely popular 4th Annual Formulation & Drug Delivery Congress, 8th – 9th May 2018, London, UK.Over 300 delegates representing global pharmaceutical organisations, leading biotech companies and internationally renowned academic institutions will gather for over 40 presentations and case studies focused on the key issues in large molecule and small molecule drug formulation and drug delivery.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement