“Explore how pharmaceutical serialization is transforming compliance and traceability in the supply chain. Learn about regulatory requirements and benefits beyond compliance.”
Let’s take a look at how pharmaceutical serialization is transforming compliance and traceability in the life sciences supply chain.
Introduction
Given the constantly evolving landscape in life sciences, it comes to no surprise that assuring quality and safety of pharmaceutical products is held on top. Meeting tough regulations is not just something you have to do, It is your duty as a medical provider in order protect the health of patients.
In addition to speeding up these processes and creating greater visibility, the serialization of pharmaceuticals has been another powerful force in this area, redefining how we answer compliance requirements within life science supply chains. In this post, a quality and regulatory consulting firm devoted to the life sciences industry provides an insight into how pharmaceutical serialization impacts compliance deeply.
Pharmaceuticals = Compliance — At a Glance
With the complexity in pharmaceutical supply chains, products move across various entities (alternate list), regions and countries before it arrives to end users’ that arepatients.
Throughout this journey the integrity, authenticity and safety of pharmaceutical products is a huge challenge. Making this more complex, there is mounting regulation on an international level.
The failure to comply results in severe consequences, Compliance failures, beyond the fact that they can put a company out of business or even land you in jail, are patient safety issues and brand reputation busters. Compliance is therefore essential and must be a top priority for any pharmaceutical company.
A General Introduction to Pharma Serialization
Pharmaceutical serialization means that each drug product will carry a unique serial number on its saleable unit. Along with other pertinent data, this serial number is logged in a central database. Serialization also facilitates end-to-end traceability, where each pharmaceutical drug can be tracked and verified at any step within the supply chain.
There are Three Primary Reasons for publishing data:
Trace/helping in product authentication: Serialization helps for you to verify if a genuine product. They are particularly important in preventing the distribution of counterfeit drugs which is a big problem throughout the pharmaceutical industry.
Recall Management: If a product is recalled, serialization ensures that the affected products could easily be identified and allow to recall only necessary goods. This diminishes the amount of waste on productive level.
Regulatory Compliance: Serialization is required by many regulatory authorities, such as the FDA and EMA to implement measures that increase security in drug supply chain.
Patient Safety: Serialization ensures that patients receive bona fide, unadulterated pharmaceuticals preventing patient harm.
Serialization for Reinforcing Compliance
Pharmaceutical serialization affects compliance in several direct and important ways
Compliance: Governments in many countries and regions around the world are requiring serialization, thus compliance is mandatory. Serialization has been introduced to match their various regulation demands at the point of time.
Data Integrity: Serialization needs to accurately record and manage a vast amount of data, back Serialization systems are designed safeguarding data integrity, a crucial compliance requirement protecting against corruption or loss of key information.
Documentation and Reporting: The serialization process also captures Indepth documentation including serial numbers, transaction history records as well as the Transaction statement. These records are critical for regulatory reporting, audits and inspections to allow businesses to showcase their compliance with confidence.
Supply Chain Visibility: Serialization imparts unrivaled transparency into the supply chain. It helps with compliance, and it enables companies to detect proactively where they fail the rules so that way corrective actions can be taken quicker before non-compliance occurs.
Serialization Law in the Wide World
The regulatory and quality requirements in the world of pharmaceutical serialization constitute a veritable minefield. Major serialization regulations and guidelines
DSCSA (FDA Drug Supply Chain Security Act):
In the US, pharmaceutical serialization is enforced with DSCSA. Deadlines for product tracing, verification and reporting in Companies must have a series of deadlines:
European Union Falsified Medicines Directive (EU FMD): EU FMD mandates serialization and verification for all prescription medicines sold within Europe. It is designed to stop fake medicines getting into the authentic supply chain.
Drug Traceability System related to China: A complete drug traceability system in China consists of serialization and data submission.
Other Global Requirements: Other countries like Brazil, Russia, United Kingdom of Great Britain and Northern Ireland have their own serialization requirements. Global regulation contend with Companies operating internationally have the Global regulatory maze
Serialization benefits that extend beyond regulatory compliance
Pharmaceutical serialization is fundamentally about compliance, but its implications extend well beyond regulatory obligations.
Patient safety: Serialization improves patient safety through preventing counterfeit, substandard or expired medications from getting to consumers.
Serialization Boosting Supply Chain Efficiency and Reducing Errors:
Serialization improves supply chain efficiency, reduces errors and assures correct inventory management.
Serialization is an essential step toward accessing global markets:
Production of high-value products such as pharmaceuticals and electronic chips often requires serialization prior to market shipping. It heightens the opportunities proliferating for you and opens more revenue streams.
Authentication via Serialisation:
Serialization of a product helps to authenticate and protect the reputation or brand integrity by preventing counterfeited products from appearing in the market.
Problems With Serialization Solution
The benefits of pharmaceutical serialization are crystal clear, but the implementation comes with its own set of difficulties.
Investment:
Serialization systems and processes require a substantial investment in technology, infrastructure, staff training etc.
Serialization systems must be able to speak and exchange data with other supply chains. This is especially difficult in a global context.
Data Management:
Serialization systems will create terabytes of data, and managing the carriers alone can be a daunting task.
Calibration to Existing Systems
Incorporating serialization systems into current enterprise resource planning (ERP) and manufacturing frameworks can be a cumbersome task.
Conclusion
Serialization now is changing the compliance and traceability of pharmaceuticals in life science supply. This is no longer an option, but a requirement in the complex regulatory world that pharmaceutical companies must navigate. Serialization guarantees dedication to compliance with varied worldwide regulations and concurrently improves data confidence, traceability, transparency, and patient protection.
As a quality and regulatory consulting firm, we recognize the importance of compliance to protect patients but also to maintain viability for our clients. We manage pharmaceutical serialization for companies, supporting them to handle the complexity of their serialization operations ensuring that they move towards compliance approach (meeting regulations) and beyond into an operational effectiveness by brand protection & patient safety.
To discover how we can help you, contact BioBoston Consulting or visit our website.
