[Stability Testing related News – vol.45]

◆  Italy joins PIC/S as from 1 January 2020 (Dec-19 PIC/S)

The PIC/S Committee invited Italy’s Directorate General for Animal Health and Veterinary Medicinal Products (DGSAF) to join the Scheme as from 1 January 2020.

Italy / DGSAF will become PIC/S’ 53rd Participating Authority. DGSAF submitted a complete membership application in August 2016. The PIC/S assessment process was a partial assessment, facilitated through the recognition of the EMA Joint Audit
Programme (JAP) audit conducted in October 2015, in line with the Letter of Agreement between PIC/S and EU/EEA Heads of Medicines Agencies (HMA). An on-site visit took place on 14-18 January 2019 to observe an inspection on biological products in order to complete the assessment.
This on-site visit facilitated the review of the implementation of corrective actions and successful finalisation of the assessment. The Audit team recommended to the Committee to accept the PIC/S membership application of Italy / DGSAF, subject to
post-approval commitments regarding some PIC/S specific requirements.

Along with other PIC/S Participating Authorities competent for veterinary medicines, the joining of Italy (Vet) / DGSAF as a new PIC/S Member will further expand the outreach of PIC/S in the GMDP veterinary field.


◆  Update on Ph. Eur. and Pharmeuropa (29-Jan-20 ECA)

The EDQM recently announced some upcoming changes to the European Pharmacopoeia (Ph. Eur.) and Pharmeuropa.

Shutdown of Ph. Eur. 9th Edition
The Ph. Eur. 9th Edition has been obsolete since January 1, 2020. Consequently, the 9th Edition online and all previous versions, including the Ph. Eur. archives for 9th Edition, will no longer be accessible starting March 1, 2020. The Ph. Eur. 10th Edition and its supplements are available to subscribers on the dedicated Ph. Eur. 10th Edition online platform. Consultation of obsolete Ph. Eur. texts remains possible for users with an up-to-date subscription (i.e. for the 10th Edition) via the Ph. Eur. archive available on the new platform.

More information is available on the Ph. Eur. 10th Edition website.

New Pharmeuropa Website
A new version of the Pharmeuropa website launched on January 24, 2020. Following the update, current Pharmeuropa users will need to register to access the new platform.

According to the announcement, the new Pharmeuropa includes new features, such as

  • single sign-on with access to other EDQM websites like Ph. Eur. online and PaedForm;
  • improved navigation;
  • tablet and smartphone friendly;
  • improved search query management;
  • a notification tool enabling users to set alerts and receive e-mails when a monograph is added to the “Texts for comment” database, or when a monograph of particular interest is added.

All users will have to register for access, even those who had access to the previous site. Full details on these new features can be found in the Pharmeuropa Online User Manual.


◆  Stability Testing Program as a Common Problem in recent FDA Warning Letters (05-Feb-20 ECA)

Stability testing of drug products is mandatory by 21 CFR 211.166 of the cGMP guidelines and is a fundamental GMP requirement. A stability testing program should demonstrate that the chemical properties of the drug products remain acceptable throughout their labeled expiry period. Inadequate stability studies that do not provide the shelf life of the product may cause the facility to fail an FDA inspection and receive a Warning Letter.

A recently published evaluation has shown that complaints regarding inadequate stability testing can be found in about every fifth Warning Letter in the fiscal years 2016, 2018, and 2019. This trend seems to continue for 2020, as three of the Warning Letters posted in January 2020 also deal with this problem.

In a Warning Letter dated January 9, 2020, to Huaian Zongheng Bio-Tech Co., Ltd., the FDA criticizes, among others, that the “firm did not have an adequate stability testing program to demonstrate that the chemical […] properties […] remain acceptable throughout their labeled expiry period.” – as recently covered in “Identity Testing and Stability Studies criticised in an FDA Inspection“.

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