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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The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or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: Resource Center Regulatory Compliance Serialization Drug Product

Case Study: Orphan Drug Product

According to the Food and Drug Administration and the Orphan Drug Designation program,  orphan status is applicable to drugs and biologics which are defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” Due to the high costs and low demands of the drug product, it is important to efficiently use your API supply during the formulation process. This case study presents how Alcami successfully helped a client overcome an API supply shortage using Quality by Design studies to successfully formulate an orphan drug product. 

Topics: Thought Leadership Resource Center Oral Solid Dose API Drug Product Formulations

White Paper: 4 Factors Critical to the Financial Success of an Emerging Pharmaceutical Company

Alcami has recently authored a white paper discussing 4 factors that are critical to the financial success of an emerging pharmaceutical company.

This paper will address company structure decision making, funding approaches, perfecting the investor pitch and hitting key milestones – the exciting and challenging journey of a growing pharmaceutical company.

 

 

Topics: Resource Center

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 Supply Chain CDMO

White Paper: Extractables and Leachables Testing in the Pharmaceutical Industry

Alcami has recently authored a white paper on extractables and leachables testing in the pharmaceutical industry.

Requirements from regulatory agencies have become increasingly rigorous, with regards to the detection, dentification and quantification of extractable and chable compounds in pharmaceuticals, drug delivery systems and biomedical devices. This increased scrutiny is the result of several well-documented incidents of contaminants leaching from containers and packaging, resulting in a potential or real risk to humans.  As a result, regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), have increased regulations on potential extractables and leachables in drug product container and closure systems. 

Topics: Resource Center Extractables & Leachables

Executive Brief: An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry

Since 1999, deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methadone—have quadrupled, causing more than 165,000 deaths in the U.S. 

Topics: Resource Center Abuse-Deterrence

White Paper: Abuse-Deterrent Studies for Controlled Drugs - A Changing Landscape

Alcami has recently authored a white paper regarding the changing landscape in abuse-deterrent studies for controlled drugs. 

  • Governmental and regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (HHS), have made significant investments towards the reduction of the misuse of prescription drugs.

    Engineering abuse-deterrent properties into prescription forms of drugs with abuse potential has become a primary strategy for abuse prevention.

Topics: Resource Center Abuse-Deterrence