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In an effort to eliminate the lucrative counterfeit medicine market and increase consumer safety, global regulations introduced to increase the traceability of prescription drugs outline the requirement for pharmaceutical companies to introduce unique identifiers on the smallest saleable units of prescription drug products.
Specifically, companies will be required to generate a unique serial number and include it alongside other product data on the drug packaging. The exact data that needs to be contained within the data matrix codes and in a human readable format varies with each country’s interpretation of the traceability initiative. Serialisation and reporting are a minimum requirement, with additional requirements for tracking drug product through the supply chain, and the ability to verify individual product at any point in the supply chain.
The scope of the different legislation is just one of the challenges that companies face trying to implement serialisation solutions. The deadlines of November 2017 (US) and February 2019 (EU) are approaching quickly and companies that are not compliant by this deadline will be unable to sell their products in these respective markets.
Implementing a robust serialisation solution should be a prerogative for pharmaceutical manufacturers, and that is where ITS can help. From requirements gathering and the creation of User Requirement Specifications through to implementation and validation, you will be in the hands of a knowledgeable company and an organisation that enjoys a wealth of experience in the pharmaceutical industry.
Established in 1991, ITS has nearly 25 years of experience in implementing fully validated solutions in highly regulated industries. Companies, pharmaceutical or otherwise, can benefit from ITS’ services, including:
- Creating User Requirement Specifications (URS) – outlining your serialisation requirements at an early stage will help to avoid expensive corrective measures later on in the process. With ITS’ extensive experience in developing detailed User Requirement Specifications, we can ensure that your needs are captured fully going forward.
- Serialisation solutions – being independent, you can be sure that ITS will design and implement a turnkey serialisation solution that is tailored to your company’s specific needs.
- Validation – Implementing new technology within a pharmaceutical manufacturing environment will require validation. ITS can offer fully validated solutions, or offer validation services for companies that have already implemented a serialisation system.
- Service Level Agreements (SLA) – Once your serialisation solution is implemented, ITS can offer an SLA to support and maintain the solution.
Supported by a wealth of testimonials, ITS has extensive experience in the design, implementation and validation of solutions for many pharmaceutical manufacturing customers. You can be confident that, by choosing us for your serialisation solution needs, you will also benefit from this experience.
With the deadline looming, ITS’ services and solutions will ease the stress of the transition for serialisation compliance for your business.