New ZLG Document on Transport Verification Published
At the end of August, the German Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG) has published a newly prepared GDP relevant document. The German-language resource entitled “Inspektion der Eignung von Transportprozessen” focuses on transport verification and its inspections by the competent authorities.
Annual Report Forms for Postmarketing Requirements
The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.
Electronic Submission Portal for Cosmetics
The U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct).
Revised USP Chapter <31> and New Chapter <1331> on Volumetric Apparatus Published for Comments
In the Pharmacopeial Forum, PF 49(5), two USP chapters related to volumetric apparatus were published for comments. It is proposed to make several changes in Chapter <31> Volumetric Apparatus. Furthermore, a new general chapter <1331> Use and Calibration of Volumetric Apparatus has been developed.
GMP and Critical Data
In the GMP environment one often talks about critical data. The term “critical data” only appears in a few places in the EU GMP Guidelines and their annexes and is also not clearly defined. How does one deal with this?
GDP in the US: Additional FDA Guidances on DSCSA
In the last few days and weeks, the U.S. Food and Drug Administration (FDA) has published several guidance documents related to the requirements under the Drug Supply Chain Security Act (DSCSA). Under the DSCSA, trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) are subject to certain requirements for enhanced drug distribution security.
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.
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.
Swissmedic launches own GMDP Database
Swissmedic is bringing a SwissGMDP database into operation, similar to the EudraGMDP database, listing GMP and GDP certificates of all companies in Switzerland.
Swissmedic Plans Database for Swiss GDP Certificates
Swissmedic plans to bring a SwissGMDP database into operation, which will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The database will make it possible to view the GMP/GDP status of a company easily and free of charge.
Product Recall Due to Possible Pest Control Problems and Temperature Excursions at the Facility
The required storage conditions for medicinal products must always be met. If deviations are discovered after the product has left the warehouse, a recall may be the consequence. This is shown by an example from the US, which is about possible pest control problems and temperatures in excess of the storage condition instructions on the product labeling.
USP: Comments possible on the Topic “Balances <41>”
The latest valid version of the USP chapter “Balances <41>” has been substantially revised and is now posted for comment on the USP Pharmacopeial Forum website. This revision follows updates to the USP chapter “Weighing on an Analytical Balance <1251>” and the general chapter “Balances” of the European Pharmacopoeia (Ph. Eur.). Comments on this draft can be submitted until 30 November 2023.
