Q1 Scientific offer ICH & non

ICH stability storage conditions for

pharmaceutical, medical device

and biologic products

Regulatory UpdatesGuidance for ANDAs (published on Q1 Scientific website July 4, 2014)ANDA submission batch samples should be stored for 1 year after approval of the ANDA and samples of the drug product used for bioequivalence studies must be stored following the requirements listed in 21 CFR 320.38 and 21 CFR 320.63

Proposed New EU Guidelines on Stability Testing Medical Devices(published on the Q1 Scientific website October 31, 2013According to proposed new EU guidelines which seek to amend current Directive 2001/83/EC on Medical Devices and a Proposal for a Regulation from the European Parliament and the Council on in vitro diagnostic medical devices, it is suggested that there will be increased requirement for evidence of stability testing medical devices.Manufacturers of Medical Devices will be required to provide data on stability testing during product development.

What is ICH?ICH stands for The

International Conference on Harmonisation of Technical

requirements for registration of pharmaceuticals for human use (ICH).

It is a project that brings together the regulatory authorities of Europe, Japan

and the United States and experts from the pharmaceutical industry in these three regions to discuss scientific and technical aspects of pharmaceutical

product registration.

Its aim is to identify and then reduce the differences in technical requirements for drug development among regulatory agencies thereby

reducing the need to duplicate the testing carried out during R&D of new medicines, ensuring more

economical use of resources and increasing the availability of new drugs

ICH Partners:1. European Commission2. European Federation of Pharmaceutical Industries

and Associations (EFPIA)3. Ministry of Health, Labour and Welfare (Japan) 4. Japan Pharmaceutical Manufacturers Association (JPMA) 5. Food and Drug Administration (FDA)6. Pharmaceutical Researchers and Manufacturers

of American (PhRMA)

From Q1 Scientific | October 2014

Stability StorageN E W S L E t t E R

To Read more about Stability Testing for Medical Devices, please follow the link on q1scientific.com Proposed EU guidelines for Medical devices 2012 Proposed EU guidelines for in vitro Medical devices 2012www.q1scientific.com

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Unit 87, Westside Business Park,Old Kilmeaden Road,Waterford, Ireland.

t: +353 51 355 977E: info@q1scientific.comW: Q1Scientific.com

Photostability Guidelines

ICH Q1B guideline is the harmonized effort to standardize photostability testing on new pharmaceutical drug substances and drug products. For companies developing or manufacturing pharmaceutical drugs, a robust photostability testing process is essential to ensure product quality and regulatory compliance.The ICH Guideline covering the Stability Testing of New Drug Substances and Products notes that light testing should be an integral part of stress testing for the evaluation of the intrinsic photostability characteristics to demonstrate light exposure does not result in unacceptable change.

Photostability testing is carried out on a single batch of material selected. Whether studies should be repeated depends on the photostability characteristics determined at the time of initial filing and the type of variation and/or change made. The guideline primarily addresses the generation of photostability information for submission in Registration Applications for new molecular entities and associated drug products. It does not cover the photostability of drugs after administration (i.e. under conditions of use) and those applications not covered by the Parent Guideline.

Procedure for Photostability Testing

For confirmatory studies samples are exposed to light to allow direct comparison between

drug substance and drug product illumination at less than 1.2 million lux hour UV energy and not less than 200 watt hours/ square meter

• Samples are exposed side-by-side to ensure the specified light exposure

• Exposure for appropriate duration of time • Monitoring is done using calibrated

radiometers/lux meters • Dark controls, if specified (wrapped in

Alufoil,) placed alongside the authentic sample to evaluate contribution of thermally induced change

Reduce and control costs

Q1 Scientific’s pay for use model is designed to reduce total cost of storage by eliminating waste and unseen maintenance, service and security costs. Our transparent contract pricing ensures total visibility of storage spend without incurring unexpected costs associated with facility and equipment management.

Focus on priority

Enable your team to focus on activity not infrastructure, by putting storage in the hands of Q1 Scientific, you can concentrate on core activities that are central to your business. Q1 Scientific sample management services seamlessly integrate with existing sample storage systems.

Transform CAPEX to OPEX

With Q1 Scientific there is no need to be locked into capital investment in storage facilities and infrastructure. By transferring long-term storage to Q1 Scientific you can optimise utilisation and ROI on existing stability infrastructure. Access storage as and when you need it, so you eliminate common under or over capacity issues and ensure access to storage when required.

Manage risk and compliance

Q1 Scientific can provide a primary or contingency storage solution with the option of a disaster recovery capability if required. We invest in best in class technology which is fully validated, controlled and monitored.

Our on-site management team are there to continuously monitor and ensure sample integrity.

Photostability Guidelines

Why Outsource Stability Storage?

Q1 Scientific offers Photostability

testing to meet regulatory guidelines

Further updates at q1scientific.com

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