Barcodes from July 2011

All Indian pharma exports will soon require barcodes on primary, secondary and tertiary packaging as part of anti-counterfeiting efforts.

In response to allegations India is a source of counterfeits, stemming, in part, from discovery of “Made in India” labels on fakes produced in China, has prompted the country to take action. The Directorate General of Foreign Trade (DGFT) issued the following change in export regulations .

“Exporters of pharmaceutical products will be required to affix barcodes on their export products to facilitate tracing and tracking of their products. In order to enable exporters of pharmaceutical products for incorporation of this technology, adequate time is being given”, said DGFT.

Manufacturers have until July 1 2011 to comply with the regulation. After this date exports must have track and trace capabilities “using barcode technology as per GS1 global standards”.

Primary packaging, such as vials and bottles, will be modified to incorporate 2D barcodes encoding a unique product identification code, batch number, expiry date and serial number.

Secondary packaging will be encoded with the same information using either 2D or 1D barcodes. Finally, tertiary packaging must use 1D barcodes to encode the same information.

Documentation

The DGTF also changed export documentation requirements. Exporters must, at the time of shipment, show a copy of Certificate of Analysis issued by: the manufacturer; or an approved laboratory of the importing country; or a laboratory approved by the Indian Drugs Controller.

Furthermore, officials of the Drug Control Department can, when required, retain a sample of a shipment for reference and tracking purposes.

http://www.cybex.in/Notifications/21-2009-Procedure-Relating-Tracing-Tracking-8675.aspx

A complete article was published in “Economic Times”

http://economictimes.indiatimes.com/news/soon-bar-code-unique-no-on-pill-strips-to-check-fakes/articleshow/7532652.cms

hello everybody,
can someone suggest me the procedure fir checking the filter integrity of HEPA filters installed in the Reverse L.A.F?

Reverse Laminar Flow units are meant to provide protection to the operator and environment. Here the floating particles are sucked within the working area towards the pre-filters with filtration accuracy of 5.0 microns and 3.0 microns. Thus creating a negative pressure zone within the working area. The air path then moves from the pre-filters to HEPA ( certified to achieve an filtration efficiency of not less than 99.97% and filtration accuracy of 0.3 microns) filters & down towards the pre-filters again.

The HEPA Filter Integrity tested essentially by using Poly Alpha Oleiphin (PAO) oil. This oil is used in particle generator and air pressure is applied to produce fine droplets or dispersed particles about 0.3 microns in size that are released on the upsteam side of the HEPA Filter. The down stream of the filter is tested for any leak or obserbation of these particles greater than 0.3 microns by using photometer probes at a distance of 2 inches. These observations are performed near 4 corners and centre of the HEPA filter under test.

Regards