GMP News - Packaging


EDQM: Updated Information on the Quality Overall Summary (Module 2)

The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. The document was first published in 2015 and is intended to provide assistance for CEP applicants.



New USP Chapter on Cured Silicone Components

The final text for USP <383> Cured Silicone Elastomers for Pharmaceutical Packaging and Manufacturing Components has been published in the USP. The chapter will become official on 1 December 2027. Early adoption of the requirements in this chapter is permitted by USP.



US Track & Trace Guidance on Verification Systems

The FDA issued the final guidance on verification systems under the DSCSA. The document covers "suspect drug systems" that trading partners must have in place to detect and respond to suspect drugs and ultimately notify the FDA if needed.



First Electronic Product Information (ePI) for Human Medicines

The EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Does this mean the end of the printed package leaflet?



Revised USP Chapter <660> Glass Containers

Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".



Ozempic Falsifications: BfArM starts Investigation

The German Federal Institute for Drugs and Medical Devices (BfArM) has taken over coordination in the case of the counterfeit diabetes drug Ozempic®, as several German states are now actively involved in the case. The agency advises all pharmaceutical companies, wholesalers as well as pharmacies to check all packages of the drug Ozempic® with utmost care.



EMA: Updates in the Product Lifecycle Management (PLM) Portal

New and revised guidance documents and materials related to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal).



BfArM/PEI: Guideline "Designation of Medicinal Products" published

The German BfArM (Federal Institute for Drugs and Medical Devices) and the German PEI (Paul Ehrlich Institute) published version 8.2 of the guideline on the designation of medicinal products at the end of July, which can be viewed on both websites of the institutes. The above-mentioned guideline was fundamentally revised in 2023 and applies exclusively to medicinal products for human use. It is intended to support marketing authorisation holders and applicants in the selection of the designation of the respective medicinal products.



FDA's Guidance on Track & Trace Standards

The FDA published the final guidance on standards for the interoperable exchange of track & trace information for certain human prescription drugs.



GDP in the US: FDA gives One-Year Reprieve on DSCSA enhanced Drug Distribution Security Requirements

The U.S. Food and Drug Administration (FDA) has published a new guidance document entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies". The document focuses on the enforcement of the enhanced drug distribution security requirements that will become effective on 27 November 2023. The authority grants a one-year extension as it does not intend to take action to enforce the requirements until 27 November 2024.



US Verification Requirements: 1 Year Additional Time for Wholesale Distributors & Dispensers

To minimize possible disruptions in the distribution of certain prescription drugs in the United States, the FDA does not intend to take action before 27 November 2024 against dispensers who do not verify the product identifiers of suspect or illegitimate products.



GDP in the US: FDA Guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act

In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."



USP-NF Stimuli Article on Chromatographic Screening for Extractables and Leachables

In the Pharmacopeial Forum, PF 49(4), a stimuli article entitled "Proposals for the Development, Composition, and Routine Use of System Suitability Standard Mixtures in Support of Chromatographic Screening for Organic Extractables and Leachables" was published.



Auxiliary Packaging Components

The USP adopted the revised general chapter <670> Auxiliary Packaging Components. In particular a new category "odor adsorbent" has been added.



How to determine the Protective Properties of Amber Glass Containers?

Colored glass containers are usually used to contain light-sensitive drug products. A previously issued USP Stimuli Article on the measurement of the protective properties of colored glass containers has now been republished. The article provides proposed maximum allowed specific transmission values for colored glass containers.


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