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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.

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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.

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Søren Lund Kristensen
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Dr Harm Otten
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