GMP News - Counterfeit Medicines

26.09.23

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.

20.09.23

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.

20.09.23

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.

20.09.23

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.

17.08.23

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."

19.04.23

APIC: FAQs on Data Integrity

In April 2023, the Data Integrity Task Force of the APIC Quality Group, which is a sector group of the European Chemical Industry Council (CEFIC), published the document "Data Integrity Frequently Asked Questions (FAQ)" on its website. This document providees numerous questions and answers on the topic data integrity that were submitted to the Task Force by the pharmaceutical industry.

28.03.23

GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

The U.S. Food and Drug Administration (FDA) has published a new guidance entitled "Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act". The document clarifies the agency's interpretation of specific terms used in the definitions of "suspect product" and "illegitimate product". It is primarily intended to assist trading partners in meeting verification obligations.

08.02.23

European Commission: Canada Part of the "White List" ?

Furthermore, the "Falsified Medicine Directive (2011/62/EU)" requires a "Written Confirmation" for the import of active pharmaceutical ingredients (APIs) from third countries. The APIs imported from countries on the so-called "White List" are an exception to this. In future, Canada will also be listed on this "White List".

30.08.22

FDA draws consequences for poor quality of hand disinfectants and UV Wands

In the follow-up to the pandemic situation, the FDA is still reviewing the manufacture and importation of hand sanitizers and identifying potentially critical hand sanitizers. This is shown by the warning letter issued to Guangzhou Orchard Aromatherapy & Skin Care Co.

27.07.22

FDA issues revised draft Guidances for Track and Trace

The Drug Supply Chain Security Act (DSCSA) distribution security requirements will come into effect in November next year. To help trading partners comply with the DSCSA, the U.S. FDA recently issued revised versions of two previously published draft guidances.

13.07.22

Serialization - Version 20 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Is it allowed to verify the authenticity of the UI when the product is not in physical possession?

10.05.22

Are You Recall Ready?

The FDA finalized the guidance on voluntary recalls to help industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco products.

13.04.22

US Track & Trace Requirements

The FDA has issued a questions and answers document to assist industry and State and local governments in understanding the effects of the Uniform National Policy on drug product tracing.

23.03.22

Version 19 of the Q&As on Safety Features

The European Commission published a new version of the Questions & Answers (Q&As) regarding the safety features for medicinal products for human use. Do the UIs of reference and retention samples taken from stock have to be decommissioned?

17.03.22

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

The U.S. Food and Drug Administration (FDA) has issued a revised draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs. This document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place.

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GMP News - Counterfeit Medicines

FDA's Guidance on Track & Trace Standards

GDP in the US: Additional FDA Guidances on DSCSA

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

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

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

APIC: FAQs on Data Integrity

GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

European Commission: Canada Part of the "White List" ?

FDA draws consequences for poor quality of hand disinfectants and UV Wands

FDA issues revised draft Guidances for Track and Trace

Serialization - Version 20 of the Q&As on Safety Features

Are You Recall Ready?

US Track & Trace Requirements

Version 19 of the Q&As on Safety Features

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

Recommended Event

ICH Q8 Training Course - Live Online Training From QbD to Process Validation

GMP News - Counterfeit Medicines

FDA's Guidance on Track & Trace Standards

GDP in the US: Additional FDA Guidances on DSCSA

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

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

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

APIC: FAQs on Data Integrity

GDP in the US: New FDA Guidance for Industry on Definitions of Suspect Product and Illegitimate Product

European Commission: Canada Part of the "White List" ?

FDA draws consequences for poor quality of hand disinfectants and UV Wands

FDA issues revised draft Guidances for Track and Trace

Serialization - Version 20 of the Q&As on Safety Features

Are You Recall Ready?

US Track & Trace Requirements

Version 19 of the Q&As on Safety Features

U.S. Pharmaceutical Distribution Supply Chain: Revised Draft Guidance on Verification Systems

Recommended Event

ICH Q8 Training Course - Live Online Training From QbD to Process Validation

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