Pharma GMP News of the Week Sep 12 2021

Pharma GMP News of the Week: 12-September-2021

Period: September 4, 2021 to September 11, 2021

U.S. Food and Drug Administration, published Notice on reopening of the comment period for ICH Q12 on post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.

The extension was proposed by Request for Extension from Pharmaceutical Research and Manufacturers of America (PhRMA)

The FDA announced on 8 September Federal Register that “reopening the comment period for an additional 30 days from the date of publication of this notice will allow adequate time for interested persons to submit comments without significantly delaying agency decision-making on these important issues.”

Source: Federal Register announcement, Request for extension by PhRMA

U.S. FDA updated guideline “Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, Guidance for Industry, April 2021”

The guideline updated on September 8, 2021

As per the FDA, this guidance is issued to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submissions in the form of questions and answers that have been received and addressed by FDA during the COVID-19 public health emergency.


MHRA has updated guidance on “Access to Electronic Health Records by Sponsor representatives in clinical trials”

The guideline updated on September 8, 2021

The guidance has been jointly developed by the Heath Research Authority (HRA) and MHRA, in consultation with the Information Commissioners Office (ICO), on behalf of the UK.

The data collected and analysed during clinical trials are verified and overseen by clinical trial Sponsors via representatives such as Clinical Research Associates (CRAs) or monitors. They will review the medical records to ensure that they match the data collected by the Sponsor, via Source Data Verification (SDV). The trial participants consent to this access of their medical records in writing, as part of the consent to take part in the clinical trial.

Increasingly, medical records are now electronic (Electronic Health Records; EHRs) and this poses the following challenges:

● direct access by the monitor/CRA to these records

● ensuring that access is restricted to only those participants in the trial

● ensuring that records of patients not in the trial, but maintained on the same system, are not accessed by the monitor/CRA


Healthcare Distribution Alliance (HDA) urges the US Food and Drug Administration (FDA) to immediately withdraw its guidance on electronic tracing

The guidance was published to build the electronic, interoperable systems called for in the Drug Supply Chain Security Act (DSCSA), scheduled for implementation on 27 November 2023.

As per the letter from HAD “The enhanced system seemingly contemplated by FDA would pose unacceptable security and compliance risks.” They also described that “We have serious concerns with the Draft Guidance’s assumption that trading partners will open up their proprietary systems for a direct connection with a government authority or with other trading partners. We do not see wholesale distributors or any other trading partners allowing federal or state government officials or other third parties direct, system-to-system connections to their records of every prescription drug product transaction in the U.S. pharmaceutical supply chain.”

Source: HDA comment, McKesson comment

Publication of a new general chapter on balances in European Pharmacopoeia Supplement 10.6

At its 168th session (November 2020), the European Pharmacopoeia (Ph. Eur.) Commission adopted a new general chapter: Balances for analytical purposes (2.1.7). This new chapter is included in Supplement 10.6 of the Ph. Eur., published in July 2021.

This addition to section 2.1. Apparatus fills a long-standing gap by setting out clear requirements for a piece of equipment that is the cornerstone of every analytical procedure described in the Ph. Eur. Weighing is one of the most common but also most critical tasks in a laboratory, as even the smallest weighing error can propagate throughout the whole analysis, affecting the accuracy of reported results.

This new general chapter complements existing guidelines for the use and qualification of balances published elsewhere. The principles outlined in it apply to all weighings performed as part of analytical procedures prescribed to establish compliance with a Ph. Eur. text. It is supplemented by the instructions related to “Quantities” given in the recently revised General Notices chapter, which is due to be published in Supplement 10.7 and which now includes a reference to this new chapter.


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