Audit trail eased by peelable labels
that should make it easier for its biopharmaceutical customers to
comply with the obligation to keep accurate batch production
records.
In most countries, regulatory authorities demand that companies record all materials that are used in the production of medicines to make it easier to identify the source of any safety or quality problems.
This is an exhaustive process, requiring staff to transcribe catalogue and lot numbers by hand at several points during the product's time at the facility, from warehousing through to its use and disposal.
Manual transcription can result in incorrect transcription or interpretation errors due to illegible writing. Millipore's peel-off labels provide an alternative this process, which is cumbersome and prone to errors as most products have lengthy alphanumeric codes.
The first products to make use of the new labels are Millipore's Durapore filters, used in the manufacture of biopharmaceuticals. George Adams, director of product management at Millipore's biopharmaceutical division, told In-Pharmatechnologist.com that this range is used at a critical stage in the production process, and the most likely place where use of the new labels could make a difference.
Use of the labels should eliminate documentation errors, enhance security and sterility assurance, and improve productivity, he noted.
The fact that such a labelling technology is needed reveals just how far the pharmaceutical industry has to go in adopting even simple documentation-enabling technologies, such as bar coding. These codes are available on just about every product used in production and could be used to keep accurate records using simple hand-held scanner devices.
However, many pharmaceutical companies have baulked at the financial commitment needed to implement these technologies across the production process, said Adams.
In time, the new labelling system will be rolled out across all Millipore's filter products that are used in manufacturing applications, he added.
