Stability Testing related News – Vol.2

◆  Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia (15-Jun-16 ECA)

The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopoeia <1231> Water for pharmaceutical purposes. The first draft version had already been published in September 2015 in the USP Pharmacopeial Forum 41(5).

First of all: there are no new or revised specifications of individual test parameters or new requirements. But the chapter has been revised structurally to ensure better readability. In addition there are now also details regarding feed water as well as for the validation and on action and warning limits. With a chapter number greater than 1000 the Chapter <1231> is not binding, but has a recommending character. The recommended temperature for hot sanitising was changed. So far temperatures of 80 ° C and greater were recommended. Now these are 65-80 ° C. Regarding the action and warning limits the USP now comprises proposals how these can be set 2 – and 3-stepped and which rationale can be used for the limit-setting. Further, the revised chapter now also provides assistance for organising sampling plans for the validation and operational phases.

The revised version of the Chapter <1231> will become effective in December 2016 and can be found in the 2nd supplement to the USP39 NF34.



◆  Example by Inspectorate for Handling Temperature Excursions(14-Jul-16 ECA)

In a recent blog of the Medicines and Healthcare products Regulatory Agency (MHRA), the inspectorate looks at one aspect of the new Annex 16 – the handling of unexpected deviations.

In the blog, MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU:

“The label claim for the product is ‘store below 25°C’, and the excursion was up to 29°C for 3 days. Existing stability data demonstrated no issues when stored at 30°C for up to 3 months. This situation would fall within the scope of ‘unexpected deviations’, provided that the shipment process was designed to comply with the registered conditions (i.e. that the excursion could be reasonably described as ‘unexpected’).” That does mean that the Qualified Person (QP) would be in a position to certify the batch.

However, MHRA states, “if there were no controls over shipment conditions, then the use of stability data as a ‘routine’ means to justify such an excursion would not be acceptable.”

To find out more please see the MHRA nspectorate’s blog “Handling of unexpected deviations”.



◆  MHRA GxP Data Integrity Definitions and Guidance for Industry: New Draft Version for Consultation (27-Jul-16 ECA)

In recent years, regulatory authorities have been struggling with data integrity issues. In particular the U.S. American FDA has tightened the awareness regarding the topic in many Warning Letters. In the meantime, data integrity has also become a focus of European regulatory authorities’ inspections. One of the first regulatory authorities to publish a “GMP Data Integrity Definitions and Guidance for Industry” in January and March 2015 was the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).

The contents of this Guidance led to a number of discussions and activities within the industry. Not all the requirements were considered appropriate. Just recently, the Agency has published a new version of the document entitled “GxP Data Integrity Definitions and Guidance for Industry: Draft version for consultation July 2016”.

The basic structure of the Guidance has been largely maintained both in the introduction and the definitions part. Primarily, the changes made concern new formulations and a few new term definitions. The following terms have been newly added:


7. Data transfer / migration.

8. Data processing.

9. Recording data.

10. Excluding data.

14. Electronic signatures.

20. Cloud providers and virtual service / platforms (also referred to as software as a service Saas / platform as a service (PaaS / infrastructure as a service (Iaas).

A News about the detailed content differences will be issued soon.



◆  Accession of Thailand / Thai FDA to PIC/S (01-Aug-16 PIC/S)

Geneva, 1 August 2016: On 1 August 2016, Thailand’s Food and Drug Administration (Thai FDA) became the 49th PIC/S Participating Authority.



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