Pharma GMP News of the Week: 25-July-2021

Period: July 18, 2021 to July 24, 2021

FDA has issued Field Alert Report Submission: Questions and Answers Guidance for Industry

Docket Number: FDA-2018-D-2326

Month of publishing: July 2021

The guidance is issued by: Office of Regulatory Affairs, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research

This guidance provides FDA’s current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. The guidance also addresses certain frequently asked questions.

The question includes following main questions as well other subtopics within these questions.

1. What is a FAR and what triggers its submission?

2. Who is responsible for submitting the FAR?

3. When should I submit a FAR?

4. How do I submit a FAR?

5. Where do I submit a FAR? 6. Should I submit a follow-up or final FAR?

Download the draft guidance

Source: fda.gov

FDA has issued Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations):

Docket Number: FDA-2020-D-1456

Month of publishing: July 2021

The guidance is issued by: Center for Food Safety and Applied Nutrition, Office of Food Additive Safety

The purpose of this document is to highlight the chemistry issues that FDA recommends that a manufacturer of recycled plastic consider during the manufacturer’s evaluation of a recycling process for producing material suitable for food-contact applications.  

This document supersedes the December 1992 “Points to Consider for the Use of Recycled Plastics in Food Packaging:  Chemistry Considerations” (1992 “Points to Consider”).  The possibility that chemical contaminants in plastic materials intended for recycling may remain in the recycled material and could migrate into the food the material contacts is one of the major considerations for the safe use of recycled plastics for food-contact applications.  Other aspects of plastics recycling, such as microbial contamination and structural integrity of the recycled plastic, are also important, but are not discussed in this document.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in FDA guidances means that something is suggested or recommended, but not required. This guidance was revised to include Paperwork Reduction Act information, containing non-substantive formatting or editorial revisions to the guidance, which was originally issued in August 2006. Revisions are noted by date at the end of the guidance.

Download the guidance

Source: fda.gov

Revision of USP <857> Ultraviolet-Visible Spectroscopy and <1857> Ultraviolet-Visible Spectroscopy – Theory and Practice

This proposal is based on the version of the monograph official as of January 1, 2020. The proposed revisions, which are in response to stakeholder comments and questions, include the following:

  • Clarify that the scope of the chapter does not apply to multichannel plate readers.
  • Remove the Xe line reference in Table 2 for control of wavelength by atomic line spectra.
  • Remove the Control of Photometric Response section as demonstrating absorbance accuracy over its intended operational range assures proper photometric response.
  • Revise for clarity the requirements and procedures for Control of Absorbance, including procedures for absorbance accuracy and precision.
  • Clarify the equation in Procedure A for the Estimation of the Limit of Stray Light as determined from the differential absorbance spectrum.
  • Replace the term “cell” with “cuvette” throughout.

Further revisions to include appropriate standards for chromatographic detectors and multichannel plate readers are under discussion and may be proposed at a later date.

Additionally, minor editorial changes have been made to update the chapter to current USP style.

The draft chapter <857> Ultraviolet-Visible Spectroscopy can be viewed here. (Note: a registration is required to access the Pharmacopeial Forum.)

Source: https://online.usppf.com

Revision of USP <1857> Ultraviolet-Visible Spectroscopy—Theory and Practice

Revision of the chapter includes:

  • Changes done in the chapter in line  with 〈857〉 Ultraviolet-Visible Spectroscopy
  • Multichannel plate reader systems excluded from this chapter
  • Replace the term “cell” with “cuvette” throughout.
  • Text for Control of absorbance revised as: To establish adequate accuracy, precision, and photometric performance of a given system, it is necessary to verify the absorbance accuracy of a system over its intended operational range by selection and use of the following procedures as appropriate for the wavelength and absorbance ranges required. Demonstrating absorbance accuracy over the system’s intended operational range assures proper photometric response.
  • Table 4 “Available CRMs for the Control of Absorbance” revised

The draft chapter <1857> Ultraviolet-Visible Spectroscopy – Theory and Practice is available to refer at this link.

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