MTS Recommends... Significant Revisions and Updates to the European Pharmacopoeia

Significant Revisions and Updates to the European Pharmacopoeia
By Susanne Keitel
Pharmaceutical Technology, Volume 40, Issue 5, pg 20–21, May 02, 2016

COURSE: How to Develop Stability Indicating HPLC Methods, 2nd & 3rd June 2016, London

New Data Integrity Guidance from FDA

FDA published a new draft Guidance for Industry in April 2016 entitled, 'Data Integrity and Compliance with CGMP', the purpose of which is to clarify the role of data integrity in CGMP for drugs and the agency's current thinking on the creation and handling of data in accordance with CGMP requirements.

The document takes the form of a series of questions and answers on data integrity issues, it is assumed that these are representative of the questions commonly asked of FDA. These include several questions which were previously posted as Level 2 guidance on the FDA website (now removed) on the topics of: paper versus electronic records; shared login accounts; and use of actual samples for 'trial' injections.

I particularly like the use of the terms 'static' and 'dynamic' (previously used in the guidance: MHRA GMP Data Integrity Definitions and Guidance of Industry March 2015) to differentiate between the different types of electronic records obtained from laboratory instruments. It is a big improvement on the previous explanation of why paper printouts were not always a viable substitute for electronic records.


MTS offers a range of services related to data integrity, click here to find out more.

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Upcoming Method Development Course

How to...
Develop Stability Indicating HPLC Methods

2nd & 3rd June 2016, Hilton Garden Inn London Heathrow, UK
Early booking rate (until 5th May): £925 + VAT (20%)
Group discounts are available on request

This course is suitable for both investigating whether an existing HPLC method is stability indicating or for developing a new stability indicating HPLC method.

You will learn:

• Why stability indicating methods are required;
• How HPLC method parameters, such as column and mobile phase, affect the chromatographic separation and how to find the best conditions;
• How to perform forced degradation stress studies to obtain potential degradation products; and
• How to investigate mass balance for analytical methods.

Visit the MTS website for more information and for the online booking form.

Other related courses from Mourne Training Services:
Validation and Transfer of Methods for Pharmaceutical Analysis
Laboratory Data Integrity


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MTS Recommends...

Impact from the Recent Issuance of ANVISA Resolution RDC-53/2015 on Pharmaceutical Small Molecule Forced Degradation Study Requirements

By Peter Tattersall, Suwimon Asawasiripong, Ivone Takenaka, and John A. Castoro
American Pharmaceutical Review, March 31, 2016

COURSE: Validation & Transfer of Methods for Pharmaceutical Analysis