Pharma GMP News of the Week: 22-May-2022

Period: May 15, 2022 to May 21, 2022

US FDA published guideline on “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision”

Date of issue: May 16, 2022

FDA has revised the guidance on OOS applied to chemistry-based laboratory testing of drugs.

The document provides FDA’s current thinking on how to evaluate OOS test results.

Source: https://www.fda.gov/media/158416/download  

US FDA published guideline on “Assessing User Fees Under the Generic Drug User Fee Amendments of 2017”

Date of issue: May 17, 2022

The objective of this guideline is to provide information regarding US FDA’s Generic Drug User Fee Amendments of 2017 also called as GDUFA II (Title III of the FDA Reauthorization Act of 2017) 

The document provides information about the new fee structure and types of fees applicable.

The guideline also gives information on how the US FDA determines affiliation for purposes of assessing generic drug user fees. For more details, read the source document.

Source: https://www.fda.gov/media/132138/download 

US FDA published guideline on “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors”

Date of issue: May 18, 2022

The objective of this guidance is to support application holders, sponsors and applicants minimize medication errors regarding prescription drug and biological product applicable for humans.

In this guidance safety aspects of the application holder’s  carton labeling and container label design are discussed. 

The guidance provides a set of principles and recommendations to ensure key elements of a product’s carton labeling and container label to promote safe dispensing, administration, and use.

Source: https://www.fda.gov/media/158522/download 

US FDA published draft guideline on “Risk Management Plans to Mitigate the Potential for Drug Shortages”

Date of issue: May 19, 2022

The objective of this guidance is to implement a risk based plan in order to support the prevention of human drug product and biological product shortages.

The plan will provide a framework to proactively identify, prioritize, and implement initiatives to prevent a supply disruption. 

Source: https://www.fda.gov/media/158487/download 

ICH published “2021 Free Text Comments Report and Consistent Cohort 2019 vs 2021 ICH Implementation Study”

Date of issue: May 19, 2022

The text has been published to analyze anonymised comments from the industry participating in the most latest survey done in 2021.

The purpose for this study was to:

  1. Provide further context to results from the survey
  2. Add value on informing training associates
  3. Inform future surveys.

Source: https://ich.org/news/2021-free-text-comments-report-and-consistent-cohort-2019-vs-2021-ich-implementation-study-now 

https://www.ich.org/page/ich-guideline-implementation

EC updated its list of formally recognized and added risk management standard to harmonized standards list

Date of news: May 2022

The European Commission has formally  added the EN ISO 14971:2019 standard in the reference list and amendment to the standard, EN ISO 14971:2019/A11:2021.

Source: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0729&from=EN 

EMA published document “Public Consultation Concerning The Physical Attendance And The Location Of Personal Residency Of The Qualified Person”

Date of paper: May 11, 2022

During the pandemic it required manufacturers and importers of medicinal products and regulatory authorities to operate under business continuity mode and that had an impact on standard way of working. In that perspective, to reduce the risks of shortages of medicine, and having high standards of quality, safety and efficacy medicines for the patients the EMA has published this consultation paper. 

Consultation procedure: May 13, 2022 – June 13, 2022

Source:https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/public-consultation-concerning-physical-attendance-location-personal-residency-qualified-person_en.pdf

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