Ph. Eur. Draft on PAT

In Pharmeuropa 30.1 a draft monograph 5.25. Process Analytical Technology has been published for comment until March 31, 2018.

According to the draft chapter "process analytical technology (PAT) can be defined as a system for designing, analysing and controlling manufacturing processes through timely measurements (i.e. during processing) of critical quality attributes (CQA), and critical performance characteristics of raw materials, in-process materials and processes, in order to ensure the quality of the final product.

Interfacing manufacturing processes with analytical techniques is essential in PAT, as it facilitates process development in accordance with quality by design (QbD) principles, enables real-time release testing (RTRT) and supports continuous manufacturing processes.

The draft emphasizes that "the term ‘analytical’ in PAT is used in a broad sense to include chemical, physical and microbiological measurements conducted in an integrated manner and combined with data analysis". The interfacing mode (e.g. ‘off-line’, ‘at-line’, ‘on-line’ and ‘in-line’) of analytical techniques with the manufacturing process is central to the application of PAT. These measurements can generate very large volumes of data, representative of the process, which then have to be further processed.

Additionally the draft chapter provides definitions for the various interfacing modes including examples of interfacing options for different unit operations and purposes together with the proposed measuring system and the typical result turnaround time. Furthermore, it contains sections on "Comparison of process analytical interfacing modes", "Statistical process control (SPC)", and "Ph. Eur. Texts supporting the application of PAT". The Ph. Eur. chapters which have been revised or elaborated to support the application of PAT include:

  • 1. General Notices,
  • 2.2.25 Absorption spectrophotometry, ultraviolet and visible,
  • 2.2.37 X-Ray fluorescence spectrometry,
  • 2.2.40 Near-infrared spectroscopy,
  • 2.2.48 Raman spectroscopy,
  • 2.9.47 Demonstration of uniformity of dosage units using large sample sizes,
  • 5.1.6 Alternative methods for control of microbiological quality,
  • 5.21 Chemometric methods applied to analytical data,
  • 5.24 Chemical imaging.

In section 1.1 of General Notices under Demonstration of compliance with the pharmacopoeia, it is stated that "a substance can be demonstrated to be of pharmacopoeial quality on the basis of product design, together with its control strategy and data derived, for example, from validation studies of the manufacturing process". Furthermore, it is also stated that "an enhanced approach to quality control could utilize PAT and/or real-time release testing strategies (including parametric release) as alternatives to end-product testing alone". This is also in line with the draft Annex 17 of the EU GMP Guide on Real Time Release Testing, which is expected to be released as final, without further modifications, in the first quarter 2018. 

After registration on the Pharmeuropa Website you will have access to the draft monograph 5.25. Process Analytical Technology.  

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