Recent Developments in analytical procedure development, validation and life cycle management for pharmaceutical quality control and stability testing | 2 part-series

Revision of ICH Q2R and new ICH Q14 (Draft) (10470)

It was announced that in addition to the revision of the ICH Q2R Guideline on Analytical Validation, a new ICH Q14 Guideline on Analytical Method Development would be developed with the aim of combining both documents in one document. The scope of ICH Q2 should be extended to cover validation principles applicable to spectrometric test methods (e.g. NIR, Raman, NMR or MS). Some of these often require multivariate statistical analysis. The guideline is intended to continue to provide a general framework for the principles concerning the validation of analytical methods applicable to products primarily within the scope of Q6A and Q6B. The new ICH Q14 guideline is intended to describe the approach to analytical method development and to introduce life-cycle concepts for analytical test methods. The guidelines (Q2(R2) and Q14) are intended to complement ICH guidelines Q8 to Q12 and the current ICH guideline Q13 for continuous manufacturing. In March 2022 the draft versions of both guidelines were published as Step 4 documents for public comment (until August 2022). In terms of the timeframe, regional implementation is envisaged to take place in May 2023, following the resulting finalisation.

The training will focus on changes in the draft of the revised ICHQ2R document, addressing all validation parameters covered by the guideline. For the ICH Q14 draft the differences between minimal and enhanced approaches for analytical procedure development will be explained. Examples provided in the annexes will be interpreted. This will include a critical assessment of the extent to which the revised paper achieves the intended objectives and the extent to which the requirements are harmonised in USP chapters <1220> and <1210>) or where discrepancies exist. This also applies to the current discussion on the differentiation between the analytical procedure and the analytical method and on the establishment of an appropriate replication strategy (without diving into heavy statistics). The training will not cover multivariate and real-time release testing analytical procedures.

Duration: about 180 minutes
Module 1 (90') – ICH Q14 | Module 2 (90') ICH Q2R2  
Language of presentation: English | Slides: English

Replicate strategy for testing in pharmaceutical quality control, risk of out-of-specification (OOS) results and the revised FDA OOS Guidance (10471)

In May 2022, the FDA published a revision of its guidance on the investigation of OOS results. The revised version contains a number of clarifications and cross-references to the Code of Federal Regulations; essentially, the text remains the same as in the version of 2006. The chapter on "Cautions", which has repeatedly given rise to misinterpretations in the past, has been rewritten. This concerns specified replicate determinations with averaging and the requirement that the mean value should be compared with the specification as the "final analytical result", as it is also described in chapter <1010> of the USP. In the revised version, the cases in which, from the point of view of the authors of the guidance, it is permissible for single values to be OOS in specified replicate determinations, are now restricted to those cases in which one sample is analysed several times (after sample preparation has been carried out). In all other cases, all single values of a multiple determination must comply with the specification. Such a view contradicts the essence of replicate determination and the respective strategy, which is not only to reduce analytical variability, but also to improve the quality of the analytical result, which represents an estimate of the true value. A good opportunity to revisit the topic of single determinations, double determinations and replicate determinations, i.e. the replication strategy, as well as the investigation and evaluation of OOS results in pharmaceutical quality control (small molecules).

Duration: about 180 minutes
Module 1 (90') – Replicate strategy | Module 2 (90') Investigation and evaluation of OOS results -
Language of presentation: English | Slides: English

...more from your speaker Dr. Markus Veit...

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