Monthly Archives: January 2012

Artwork Auditor Tip 12 – Is everyone using the correct version of a document?

We discussed the issue of ensuring that the evolution of a document is identified robustly in Tip 10. Having uniquely identified different versions of a document, the next thing to ensure is that everyone in the process is using the … Continue reading

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Artwork Auditor Tip 11 – Are there methods in place to ensure different forms of each document are the same?

We live in a world where we constantly deal with documents in different interchangeable formats. Rarely are the documents we deal with today created on paper, normally they are created electronically and shared using a number of different electronic and … Continue reading

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Artwork Auditor Tip 10 – Is there effective document version management in place?

As with all document management activities, it is essential that everyone is clear which iteration of a document needs to be used at any particular time in the process. Many errors have occurred in artwork management processes because this has … Continue reading

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India delay Primary and Secondary export packaging serialisation requirements

In a Public Notice dated 22nd December 2012, the Indian Ministry of Commerce and Industry announced deferred dates for the requirements to serialise, track and trace Secondary and Primary level export product packaging. The revised dates are as follows and … Continue reading

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Brazil’s ANVISA update their serialisation track and trace requirements

In a press release from ANVISA dated 8th December 2011, the results of the Brazil Government Integrated Task Force review of the serialisation legislation (Law No. 11.903/2009) were announced. An intention to implement full tracking of serialised product through the … Continue reading

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Artwork Auditor Tip 9 – Is an audit trail created and held for an appropriate period of time?

An adequate audit trail should be maintained to ensure that it can be demonstrated that the process was carried out completely and correctly. It can also be beneficial to record additional information in the audit trail to assist with continuous … Continue reading

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German serialisation pilot due to begin in January 2013

In January 2013 securPharma are planning to start a medicines serialisation pilot designed to demonstrate the requirements of EU Directive 2011/62/EU in the German market. securPharma is a German organisation involving the whole German pharmaceutical supply chain in improving supply … Continue reading

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