Monday, 23 May 2016

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

Tuesday, 3 May 2016

New Data Integrity Guidance from FDA

Click here to view the New Draft GuidanceFDA published a new draft Guidance for Industry in April 2016 entitled, 'Data Integrity and Compliance with CGMP', the purpose of which is to clarify the role of data integrity in CGMP for drugs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.


Monday, 2 May 2016

Help on: How Much Forced Degradation?

Click here to see more MTS Helpdesk
Do you have any problems relating to analytical chemistry for pharmaceuticals or training? Send your questions to the MTS helpdesk using our contact form.

When I forcibly degrade my drug or drug product to create degradation products, how much degradation should I aim for?

The aim of a forced degradation study is to generate degradation products from a drug which are both realistic and representative, typically for the purposes of assessing degradation pathways, or to create suitable samples that will allow the development of a suitable analytical method which can be used to assess the stability of the drug throughout its shelf-life.

If too little degradation occurs then it is difficult to evaluate what might happen in real time and to develop a method which can reliably determine the amount of the degradation products which could occur.

If too much degradation occurs then there is a risk that important degradation products may be further degraded and unimportant degradation products, which would not occur on storage, may be formed.

Find out more about forced degradation studies on the MTS course, 'How to Develop Stability Indicating HPLC Methods'The generally accepted industry norm for the optimal amount of degradation is between 5 and 20%, typically aiming for around  10%. Anecdotally, there is a suggestion that the 10% corresponds to the usual specification for a drug product in the US of 90 to 110% label claim.

These numbers are not quoted in regulatory guidance with the exception of the guidance from Brazil (ANVISA Resolution RDC-53/2015) which directs that results must have > 10% degradation per condition and results that are < 10% degradation, after reasonable attempt, must have scientific justification.

Find out more about forced degradation studies on the MTS course, 'How to Develop Stability Indicating HPLC Methods', click here for more information.