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Beyond the Label: Four Challenges to Serialization

Many pharmaceutical manufacturers are concerned about label design and placement to accommodate a serialized label. These are, of course, very legitimate concerns. However, there are much more complex issues at hand, including the importance of standardization, scaling information technology infrastructure, agility to accommodate regulatory changes, and data security.

Why Serialization Matters
The first objective of any pharmaceutical company is to deliver safe and effective medicines to patients. While historically there have been methods to provide product visibility and control along the supply chain, the processes have been highly manual, with paper-based record keeping being the prevalent modality.

Topics: Regulatory Compliance Serialization Supply Chain

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance.

This case study shows how Alcami has successfully transferred clients into the new serialization program.

Topics: Drug Product Resource Center Serialization Regulatory Compliance

Alcami Presenting and Exhibiting at PharmaTalk

Alcami will be presenting and exhibiting at PharmaTalk 2018 to be held June 5-6 2018 in Berlin, Germany. Be sure to visit us at our booth to connect with the Alcami team.

Presentation

Serialisation – Approach to Implementation and Execution

Topics: Events Serialization

Understanding Pharmaceutical Packaging

For oral solid dose (OSD) pharmaceuticals, decisions regarding the type of packaging used are critical to the success of a product. The best formulated product in the world can fail if it is contained in an inappropriate package. So how does one decide which packaging to use for a product?

First and foremost, the package has to protect the product from damage or degradation. Different barriers can protect from moisture, light, or gases, such as oxygen or carbon dioxide. Blistered products may use cold-formed aluminum to block light completely. Vials, at times, use light protective sleeves for the same purpose. Bottled products may require the use of a coil to keep tablets from breaking during shipment. Alcami works with clients to customize the best package configuration for product protection.

Topics: Thought Leadership Serialization Packaging Pharmaceutical Packaging Oral Solid Dose

Editorial: Is industry ready for the serialisation shake-up?

Alcami recently authored an article featured in Chemistry World titled "Is industry ready for the serialisation shake-up?"

The regulation few outside of pharma have heard about

Within the next year, pharmaceutical industries in the US and EU will undergo what could be considered one of the greatest regulatory shake-ups in the modern era. Government regulation – coming into force in late 2018 and early 2019 for the US and EU respectively – dictates that all pharmaceuticals be subject to track-and-trace capabilities, also known as serialisation.

Topics: Thought Leadership Editorials Serialization

Serialization CDMO Checklist

Given that serialization execution is new to many in the industry, what should drug developers look for when reviewing a new contract development and manufacturing organization (CDMO) that will be manufacturing serialized product or when approaching the project with existing CDMOs?

Topics: Thought Leadership Serialization Regulatory Compliance

Editorial: Implications of Serialization for the U.S. Pharma Industry

As published in Pharma's Almanac Q2 2017.


New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance carries the risk of significant consequences. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward.

Topics: Thought Leadership Editorials Serialization Regulatory Compliance Supply Chain

Serialization - Data Management Challenges

The implementation of the Drug Supply Chain Security Act (DSCSA) requirements poses many challenges. There can be an impact on productivity if your Serialization and Track/Trace systems are not prepared. Poor implementation plans can cause operational bottlenecks for several years as additional requirements are steadily implemented from now to 2024. As each system goes online, it will be necessary to “work out the bugs” and provide additional training for production and warehouse personnel.

Topics: Regulatory Compliance Serialization Supply Chain

White Paper: Guide to Pharmaceutical Serialization 2017

As required by the Drug Quality and Security Act (DQSA) signed into law by President Obama on November 27, 2013, serialization will be required by pharmaceutical manufacturers on all commercially distributed prescription human drug products effective November 27, 2017. 

This guide is designed to serve as a reference for the core information, issues, and questions pharmaceutical companies must address as they work with their CDMO and other members of their supply chain.

Topics: Resource Center Serialization CDMO Supply Chain

FAQs on What Happens If You Miss the Serialization Deadline

Serialization affects all stages of the supply chain and with many companies, small and large, unprepared for the scope of regulations and data support required it leads to the question: what happens if you miss the serialization deadline? This blog is intended to shed light on what to be ready for and what consequences will take place if you do not make the November 27, 2017 deadline.

Topics: Regulatory Compliance Serialization Supply Chain