Pharma GMP News of the Week Aug 8 2021

Pharma GMP News of the Week: 8-August-2021

Period: August 1, 2021 to August 7, 2021

US FDA published guideline on “Development and Submission of Near Infrared Analytical Procedures Guidance for Industry”

Date of publishing: August 6, 2021

This new guidance provides recommendations to applicants to aid the development, validation, and use of near infrared (NIR)-based analytical procedures in evaluating the identity, strength, quality, purity, and potency of drug substances and drug products.

The guidance is applicable for new drug applications (NDAs), abbreviated new drug applications (ANDAs), Supplemental NDAs and ANDAs for small molecule drugs, and Drug substances and drug products covered in Type II drug master files. Scope of biological products will be added in future revision to this guidance.

The guidance is complementary to the PAT guidance published by FDA in September 2004.

The guidance’s concepts of validation can be applied to other process analytical technologies (PATs), including, for example, Raman, focused beam reflection measurement, particle imaging, and X-ray.

This guidance addresses the NIR-specific features that are not addressed in ICH Q2(R1). NIR analytical procedures typically combine the following features:

• Instrumentation elements (e.g., an analyzer consisting of an NIR spectrophotometer, a reflectance or transmission probe, or spectral analysis software)
• Acquisition parameters
• A sample presentation (interface)
• A sampling scheme for process applications
• The composition of spectral datasets
• Spectral pretreatments
• Wavelength ranges
• A chemometric model

For NIR-based process analyzers, Off-line, At-line, On-line, or In-line modes of measurement are commonly used.

The guideline provides detailed information about an application submission. Because of the unique characteristics and complexity of NIR procedures, as compared to conventional analytical procedures, FDA also provided detailed recommendations for reporting post-approval changes to NIR procedures.


Download Guideline

MHRA updated a guide to defective medicinal products after 16 years

Month of publishing: August 2021

This guidance is on defective medicines and substances used in their manufacture or packaging which may also be defective. The earlier version of the guide was published in 2005.

The changes are made to reflect the UK’s departure from the European Union.

The document provides guidance to the pharmaceutical industry on handling and investigating suspected quality defects. It also gives details of both, the legal requirements and the
MHRA expectations with regard to product quality related complaints, investigations and recalls.

MHRA has updated its approach to risk classification. It uses National Patient Safety Alert (NatPSA) for defects where Class 1 represents a risk of death or disability. Class 2, 3 and 4 are to categorize lower-risk defects.

Download Guideline


Survey of Notified Bodies on Remote Audits: Successful or Unsuccessful?

The survey was conducted by the European Association of Medical Device Notified Bodies (TEAM NB). Out of 52 requests, 46 had participated in the survey with a total of more than 33,000 audit days. The answer to the question “What is your experience with remote audits?” was 90% successful and 10% generally unsuccessful.

Sharing experience is categorized below:

Decreases travel time and costIssues when there is a large time difference
Tight focusIssues with internet connections
Easier to take notesVideo does not permit to see and look for as if we were onsite
Very effective for non-physical processes (like software) and pure QMS aspectsGenerally, the spontaneousness of auditing, i.e. reacting immediately to an issue/sample picking
The verification of the quality of records is more accurate than in an onsite audit 
Remote audits are more successful with established customers 

Download useful information:

1. Position Paper,

2. Remote Audit Analysis,

3. Survey of Remote Audits


FDA grants industry 30-day extension to comment on track and trace guidance under the Drug Supply Chain Security Act (DSCSA)

The US Food and Drug Administration (FDA) has agreed to give the pharmaceutical industry more time to comment on a draft guidance calling for the establishment of electronic systems to track products through the supply chain.

The Pharmaceutical Distribution Security Alliance (PDSA) and the Healthcare Distribution Alliance (HDA) made request for extension. 


Federal Register
PDSA request for extension
HDA request for extension

Registration open for 2021 Seminar on “GMP Assessment Approaches in Post COVID-19 Era”

Date of announcement: August 2, 2021

Deadline for registration: October 3, 2021.

Seminar will be hosted virtually from 9-11 November 2021 are now open (for Medicines Regulatory Authorities only).

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea is pleased to announce that the 2021 PIC/S Virtual Seminar will be hosted by MFDS from 9 to 11 November 2021.

The Seminar on “GMP Assessment Approaches in Post COVID-19 Era” will consist of presentations, interactive panel discussions, and workshops for GMP Inspectors from around the world.

As the COVID-19 pandemic has put restrictions on GMP on-site inspections, various alternative GMP assessment approaches have been taken by regulatory authorities to ensure the quality of pharmaceuticals. As we face the post COVID-19 era, there is a need to explore the current and future status of these GMP assessment approaches. There is also a need to be prepared for the changes that will likely be seen in post COVID-19. Therefore, in this Seminar, we look forward to valuable presentations and discussions regarding different experiences in distant assessment from regulatory and industry experts; and regarding the status of GMP assessment based on reliance.

The Seminar is open to the participation of Inspectors from medicines regulatory authorities around the world.

For more information, please contact the PIC/S Secretariat.


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