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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 Regulatory Compliance Serialization

ON-DEMAND WEBINAR: Elemental Impurities - Missed the Deadline? Now What?

Join Alcami for a webinar to learn more about elemental impurities and the updated regulatory requirements.

It’s official! The methods outlined in USP General Chapter <231> are retired. If you missed the January 1, 2018 deadline, we are here to help. Our in-house experts will share our approved testing plan that can be submitted to the FDA to help ensure you are moving to compliance, and will highlight experiences gained while working with the new regulations.

Topics: Regulatory Compliance Webinars Elemental Impurities

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 Regulatory Compliance Serialization Supply Chain Editorials

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

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

Serialization Overview: What’s Required for November 27, 2017 Deadline

New requirements under the Drug Supply Chain Security Act (DSCSA) have been set for manufacturers, repackagers, wholesale, distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014 with additional requirements continuing to be phased in until 2023. The November deadline is part of the multi-year initiative to secure the supply chain for pharmaceuticals in the U.S.

The goal of the DSCSA is to enable tracking of drug product down to the individual unit of sale and to improve detection and removal of counterfeit products in the drug supply chain along with facilitating more efficient drug recalls.

Topics: Regulatory Compliance Serialization Supply Chain

Elemental Impurities – Highlights of the Coming Regulation

Replacement of the wet chemistry “heavy metals” limit tests with more modern analytical methodology and conformance to new and specific limits for individual elements was a dramatic, although anticipated, change in the regulation.

The ICH recognized that prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing pharmacopoeial procedures included the Heavy Metals test, Residue on Ignition/Sulfated Ash test and other wet chemistry tests. The problem with these procedures was that they were non-specific and were never intended to detect the low-level residual metal catalysts and reagents used in some modern synthetic processes. In addition, the acceptance criteria were based upon historical precedent and, although risk factors for metal contamination had changed significantly throughout the 20th century, the existing limits had not changed accordingly and had little toxological basis.

Topics: Regulatory Compliance Elemental Impurities

Elemental Impurities: The Risk-Based Approach

The U.S. Pharmacopeia (USP) intends to remove the existing wet chemistry heavy metals methods outlined in USP General Chapter <231> by January 2018. Although the existing wet chemistry methods have been in effect for nearly 100 years, the methods are non-specific and frequently fail to detect or underestimate the presence of some toxic elements that are potentially present in pharmaceutical ingredients. The USP requires Plasma Spectrometry (ICP-MS or ICP-OES) as the technique to screen and/or accurately quantitate the presence of any elemental impurities of interest.  From a compliance perspective, the new guidance for elemental impurities (USP<232>and ICH Q3D) only applies to the drug product.  There are currently two strategies to meet the requirements for elemental impurities, with the first being a Risk-Based approach.

Topics: Regulatory Compliance Elemental Impurities

Elemental Impurities: Updated Regulatory Requirements

In 2013, the International Conference on Harmonization (ICH) approved ICH Q3D, a Guideline for Elemental Impurities, which replaced wet chemistry "heavy metals" limit test, such as USP <231>, with new analytical technology, specifically inductively coupled plasma (ICP) - based technologies, and mandated conformance to new and specific limits for individual elements. This action by the ICH triggered prompt reactions by the U.S. Food and Drug Administration (FDA), United States Pharmacopeia (USP) and European Pharmacopeia (EP) to harmonize with the ICH requirements.

Topics: Regulatory Compliance Elemental Impurities

Serialization and Track and Trace

Are you ready for the new regulatory requirements for Serialization and Track and Trace scheduled to take effect in November of 2017?  Our recent upgrades to packaging lines for full serialization and aggregation capability can support your organization’s transition to providing product that is fully compliant with the new regulations. Get prepared by partnering with us!  

Learn more about the important changes to Serialization and Track and Trace Requirements:

Download Serialization and Track & Trace Overview

Topics: Regulatory Compliance