EP UPDATE: Pharmacopoeial & Regulatory Review 12 Jan 2018

EP UPDATE: Pharmacopoeial & Regulatory Review, Jan 2018

The following general chapters have undergone a revision to include the test details for orodispersible films and as these additions applies to EP only and all chapters are no longer harmonised with the USP/JP.

• 2.6.12. Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests
  
• 2.6.13. Microbiological Examination of Non-Sterile Products: Test for Specified Micro-Organisms
  
• 5.1.4. Microbiological Quality of Non-Sterile Pharmaceutical Preparations and Substances for Pharmaceutical use

5.25. Process Analytical Technology

This is a new 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. It is important to note 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 goal of PAT is control of the manufacturing process and enhanced process understanding, guided by risk management. Interfacing manufacturing processes with analytical techniques is therefore 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.

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