WHY IS IT IMPORTANT?

All over the world there are different laws on how to identify the hazardous properties of chemicals (called ‘classification’) and how information about these hazards is then passed to users (through labeling and safety data sheets for workers).

This can be confusing because the same chemical can have different hazard descriptions in different countries. For example, a chemical could be labelled as ‘toxic’ in one country, but not in another. Therefore UN has brought together experts from different countries to create the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).

The aim of the GHS is to have one worldwide standard for:

• The criteria for classifying chemicals according to their health, environmental and physical hazards
• Hazard communication requirements for labelling and safety data sheets.

WHO IS IT RELEVANT TO?

GHS is relevant to any organization supplying products or working in chemical manufacturing and distribution.

Where can I find out more about the GHS?  Visit www.unece.org/trans for more information.

HOW CAN PRISYM ID HELP?

PRISYM Chemica Labeling Software offers manufacturers and distributors a single solution to meet their packaging and chemical labeling requirements. PRISYM Chemica is a simple to use, label design application which allows you to place the required symbols/ pictograms, text, branding and codes onto your labels in compliance with chemical industry regulations including CHIP4 and CLP.

It enables the management of chemical classifications and automates the production of labels and transit cards in multiple languages.

ePedigree

ePedigree is based around creating an electronic record surrounding chain of custody and chain of ownership (sale) of prescription medicines and medical devices within the supply chain. It contains information on all transactions from the time a pack or logistics unit leaves the manufacturer to the point it enters a pharmacy or someone dispenses the drug. Encompassing the entire shipping and wholesale process, it critically includes wholesalers who may be responsible for repackaging into other unit levels e.g. from pallet to case.

Mass Serialization

Mass Serialization is about allocating a unique serial number to all products at the item level – sometimes referred to as a UID (unique identification). Traditionally, numbers or identifying codes would be sequential, but as part of an anti-counterfeiting initiative this is inadequate. Sequential serial numbers can easily be predicted by counterfeiters and replicated along with batch / lot codes and expiration dates. Therefore a mechanism needs to be in place to allocate random numbers so they are non-predictable.

In the case of pharmaceutical serialization it’s normally on secondary packaging such as patient pack or retail level (carton). Where appropriate it can be on primary packaging such as a blister. While creating a system for generating, allocating and encoding products is complex, it brings many advantages for track and traceability. This applies to combating counterfeiting and wider business process improvement within the internal and external supply chain.

Bringing ePedigree and Serialization Together

There is some overlap between the two methods. ePedigree can carry data about serialized product and packaging as part of the transaction record. In the US, the FDA has already put forward a guidance to serialize products at the item level. This item level data can be linked to the initially larger aggregated packages which carry their own unique identity. As packs get split or de-aggregated and moved onto other supply chain ePedigree records, the serial numbers and their initial pedigree can be linked and traced back to their origin.

For more information on ePedigree and Serialization, go to visit Prisym ID validated labeling solution product page

Consider How You Will Use Them

Different technologies are better suited to certain applications. Because barcodes require a direct line of sight, they work better when the view of the barcode is not hindered in any way. For example, barcodes are used in hospitals in the US on patient wristbands and diagnostic equipment. These can be challenging locations for a barcode scanner. RFID tags, on the other hand, can be implanted in patients and attached to costly equipment and can be read from anywhere inside the hospital.

Which Way is More Efficient?

RFID can read over 100 tags at a time, whereas scanning barcodes is a much more manual procedure, requiring them to be scanned one at a time.

Is One More Accurate Than the Other?

Both RFID and barcoding is as good as the information in the tag or the barcode. Both have the possibility of human error in data entry. Information can also be affected by faulty system design, duplicate reads, skipped reads and other factors.

Which Holds More Information?

One of RFID’s strengths is that a tag holds more data than a barcode does. In turn, additional information can be written to the tag as it passes through the supply chain. However, 2D barcodes capture more information in a smaller space than traditional barcodes.

Is One More Secure than the Other?

Privacy is an important issue in the life sciences industry. A printed bar code label doesn’t reveal much information to an outsider; passive and active RFID tags reveal a lot more. However, when it comes to counterfeiting, RFID tends to be a more secure option. RFID tags are difficult to replicate and data can be encrypted, password protected, or permanently deleted, so information stored is much more secure. Barcodes are much easier to reproduce than RFID tags.

Cost

One of the hindrances of RFID technology has been the cost. Barcode technology is much cheaper to implement and maintain than RFID technology.
Tracking for pharmaceuticals, medical devices and clinical trials is an important part of FDA compliance, so it’s important to choose the system that works best for your organization.

For more information on this topic, visit Prisym ID Labeling Software products page

Why is it Important?

The chemical industry is in transition from country specific standards to European regulation known as CLP. This means your organization must comply with the following regulations and timelines.

At present, the regulatory framework consists of two separate but interconnecting systems for classification. The incumbent system is based on the EU Dangerous Substances Directive (DSD) and Dangerous Preparations Directive (DPD). For example, currently in Great Britain the implementation of this system is via the ‘Chemical Hazard Information and Packaging for Supply’ (CHIP 4) regulations, however on 1st June 2015, the DSD and DPD (and country specific standards such as CHIP 4) will be repealed by the CLP Regulation 2008.

CLP 2008 is the EU and EEA implementation of the Global Harmonized System (GHS) model for classification, labeling and packaging of chemicals, published in January 2009. All substances must be classified or reclassified under CLP by 1st December 2010 and all mixtures (preparations) by 1st June 2015.

For the duration of the transitional period (up to 1st June 2015), all products must be classified under both systems. However, once a product has been reclassified under CLP, communication of that classification (safety data sheet and label) should be to CLP. The safety data sheet must contain reference to the CHIP classification but the content must be consistent with the new CLP classification. Dependent on the component parts, CHIP 4 requires the use of tables in CLP in order to complete the CHIP new classification of a product.

Regardless of the classification system used, all safety data sheets must conform to Registration, Evaluation, Authorization and Restriction of Chemicals (REACH 2006) with regards to content and provision.

Who is it Relevant to?

CLP is relevant to any organisation supplying products or working in chemical manufacturing and distribution. To find out more about the CLP, Visit http://echa.europa.eu/ for more information.

How can PRISYM ID help?

PRISYM Chemica Labeling Software offers chemical manufacturers and distributors a single solution to meet their packaging and labeling requirements. PRISYM Chemica is a simple to use, label design application which allows you to place the required symbols/ pictograms, text, branding and codes onto your labels in compliance with chemical industry regulations including CHIP4 and CLP. It enables the management of chemical classifications and automates the production of labels and transit cards in multiple languages.

UDI aims to reduce medical errors involving medical devices by:

• Providing a single, globally-accepted source for positive identification of medical devices
• Ensuring the adequate identification of the device through its distribution and use
• Providing rapid access to key attributes relating to the device
• Simplifying integration of information on device use into medical records
• Providing a means of added depth to patient and physician educational materials without adding greater complexity

UDI also aims to provide for more rapid resolution of device problems by:

• Making it possible to more rapidly identify devices involved in adverse events
• Providing for more rapid resolution of confirmed problems
• Provide a single, globally-accepted “key” that can be used to link and integrate existing government, hospital, and corporate data bases that relate to medial devices
• Meet other Federal agencies’ needs for a single, consistent means of identifying medical devices
• Reduce the costs of moving medical devices in international commerce

WHO IS IT RELEVANT TO?

UDI is relevant to any organisation working in or supplying medical device products to the US. Where can I find out more about UDI? Visit www.fda.gov for more information.

Prisym Medica Labeling Software:

PRISYM Medica labelling software is a purpose designed labelling solution for Life Science organisations that need to meet the FDA’s labelling regulations. Medical device companies can easily implement UDI utilising the PRISYM Medica Solution. PRISYM Medica is supplied as a validated labelling solution including auditable security protocols and lifecycle documentation based on the GAMP V Model.

Available both as a thin or thick client, PRISYM Medica allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging. It can also simply link to ERP and MRP systems to ensure that information from production can be delivered to the label at time of print.

First, you can’t afford to be random about random numbers. While it is not difficult to create a few thousand different numbers, the reality is that even in a particular batch you could need a hundred times that. Across multiple product lines and over a period of years it could amount to many million. Any solution must be scalable and sustainable.

The very nature of randomization means that numbers can be unintentionally repeated which would seriously compromise the reliability of your system and potentially endanger patient safety. Generating and managing unique numbers requires a highly robust and validated solution.

It is further complicated by the fact that you could have a serial number for one product that is the same for another product. This raises the most fundamental issue surrounding serialization. How you manage and administer number generating and allocation and what’s the best approach to keeping it both logical and simple?

Want to know more? why not download the entire white paper from PrisymID , also leave a comment below add your insight and your experience in this area, we love to hear from you….

• National Reporting and Learning Service
• National Clinical Assessment Service
• National Research Ethics Service

THE NATIONAL REPORTING AND LEARNING SERVICE (NRLS)

Aims to identify and reduce risks to patients receiving NHS care and leads on national initiatives to improve patient safety.

Through its national reporting system, the NRLS collects confidential reports of patient safety incidents from healthcare staff across England and Wales. Clinicians and safety experts help analyse these reports to identify common risks and opportunities to improve patient safety.

Feedback and guidance are provided to healthcare organisations to improve patient safety. These include alerts to address specific safety risks, tools to build a strong safety culture and national initiatives in specific areas such as hand hygiene, design, nutrition and cleaning.

The NRLS works closely with royal colleges, frontline staff and organisations, patient groups, strategic health authorities, other NHS bodies, academic centres and sectors beyond healthcare to promote patient safety.

Through its funding and monitoring of the three independent National Confidential Enquiries (patient outcome and death, maternal and child health, and suicide and homicide by people with mental illness), the NRLS can maximise the benefits of their in-depth research to better improve patient care.

THE NATIONAL CLINICAL ASSESSMENT SERVICE (NCAS)Supports the resolution of concerns about the performance of individual clinical practitioners to help ensure their practice is safe and valued.

NCAS does this through two closely collaborating aspects of its service. Its case management service gives expert advice and support to local healthcare organisations and their staff. Where necessary, this is amplified with specialist assessment of performance and support of local action planning to restore and assure safe practice.

NCAS also works with healthcare organisations to share its experience, with the aim of helping healthcare services deal effectively with performance concerns. This is done through the publication of themes, trends and results emerging from its work, and educational events.

NCAS currently provides a service to healthcare organisations throughout the UK and its associated island administrations, crossing both public and private sectors covering doctors and dentists and pharmacists.

THE NATIONAL RESEARCH ETHICS SERVICE (NRES)

Protects the rights, safety, dignity and well-being of research participants that are part of clinical trials and other research within the NHS. It also facilitates and promotes ethical research.

NRES protects research participants by maintaining a UK-wide system of ethical review via NHS Research Ethics Committees (RECs).

RECs review research applications and give an ethical opinion regarding their proposed participant involvement. Applicants include: pharmaceutical and medical device companies; healthcare professionals in the NHS; academic researchers including students; and prison health researchers.

RECs are entirely independent of research funders and hosts. This enables them to put participants at the centre of their decision making.

NRES has undertaken various initiatives to progress ethical research in the UK and always looks to build researcher and public confidence in the review service.

WHO IS IT RELEVANT TO?

The NPSA is relevant to any organisation supplying products or working in the UK healthcare market. To find more information visit http://www.npsa.nhs.uk/

Prisym Pharmacy Labeling Software:

PRISYM Pharmacy software is a purpose designed labelling solution for healthcare organisations, specifically developed to help you meet current compliance requirements including MHRA, NPSA and CLP. PRISYM Pharmacy is supplied with life-cycle documentation based on the GAMP V Model.

PRISYM Pharmacy allows you to design, review, approve, print, reprint and reconcile your labels with the peace of mind that it has purpose built user security, group security and secure audit logging as well as data integrity.

What is pharmaceutical Serialization labeling?

Many different solutions are being trialled across the world, all focused on reducing the impact of fraud within the pharmaceutical industry. Most involve the application of a unique random identifier that can be verified at – various parts of the supply chain – point of issue to the end user.

Systems need to allow these unique numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.

Label Printing

During production, when label printing or marking directly onto products, all print actions need to be automatically recorded including details such as who, what (batch, lot, GTIN and serialisation code), when and why are all written to a secure location on the server.

The security of both the client and the server is ensured by a combination of the operating system and application software. The security is well proven and documented as part of the system validation support services.

How Prisym ID can help?

Prisym Medica allows these unique random identifier numbers to be coded to the appropriate standard (GS1, RFID, DataMatrix) and then to be applied to the product quickly and efficiently, using existing technology where appropriate.

PRISYM Medica is specifically developed to meet the FDA’s current requirements and is fully supported by our own software life-cycle documentation based on the GAMP ‘V’ Model.

Working with Oracle Pedigree and serialization labeling Manager which can provide very high volumes of unique, secured and ‘intelligent’ serial numbers, PRISYM Medica for Oracle can ensure that your business can meet the requirements for serialized products now and in the future.

WEBSITE CONTENT DISCLAIMER

The information contained in this website is given in good faith for general information only and is subject to change without notice. PRISYMID uses reasonable efforts to ensure its accuracy but makes no representation and gives no warranty as to its accuracy or otherwise. To the fullest extent permitted by law all such representations and warranties whether expressed or implied are excluded.

Nothing in this website is intended to be nor should it be construed as being an offer to enter into a contractual relationship.

PRISYMID accepts no liability for any loss or damage howsoever arising, whether direct, indirect, special or consequential, which may be suffered by any person in accessing, downloading, using or relying on any information or other materials contained in this website, save that nothing in this notice shall restrict or exclude the company’s liability for death or personal injury resulting from PRISYMID negligence of for fraud or to the extent otherwise not permitted by law.

We would like to here from you !! If you wish to link to this website, please contact us at info at prisymid dot com for more details.

The new challenges presenting themselves to the pharmaceutical manufacturing industry include the creation of unique serialization codes for individual products during the production process, the secure high-speed printing and verification of these codes, plus the subsequent efficient storage and retrieval of any of these millions of codes at any point within the lifecycle of a product and beyond.

Serialization is vital in the fight against counterfeiting. To support this strategy, so is the development of web-based labeling and management solutions that help in delivering secure and compliant printing for mass serialisation and data management to enhance existing production lines or provide a complete turnkey solution. Other benefits of serialization include the ability to track product movement throughout the supply chain to help improve efficiency. The need to comply with evolving regulatory and compliance environments, and build confidence in the efficient storage and retrieval of products throughout their lifecycle will become essential.

PRISYM ID and Oracle have joined hands to present a free webinar on Wednesday, May 12, 2010 addressing this very issue. Register today and also receive a free serialization whitepaper! “When serialization could be your answer to global anti-counterfeiting”

……… you can’t afford to miss this session!