Pharma GMP News of the Week: 31-July-2022

Period: July 24, 2022 to July 30, 2022

US FDA published final guidance on “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices”

Date of news: July 25, 2022

The objective of this guideline is to include US FDA’s compliance policy related to GUDID submission requirements for certain devices of class I category. 

The agency does not intend to enforce the Global Unique Device Identification Database submission requirements under 21 CFR 830.300 for devices of above class which are considered to be consumer health products and it is required to bear a UDI on its labels and device packages. 

Furthermore, US FDA don’t want enforce the submission requirements of GUDID under 21 CFR 830.300 for above class and unclassified devices, other than life-supporting, implantable, or life-sustaining devices, regardless of its category as consumer health products, before 8-December-2022.

GUDID – Global Unique Device Identification Database 

Source: https://www.fda.gov/media/110564/download 

EDQM website seeks stakeholder consultation on draft guidelines for medication review

Date of news: July 26, 2022

As per EDQM website, the agency is seeking the opinions from stakeholders on its draft guidelines for medication review. 

Source: https://www.edqm.eu/en/-/stakeholder-consultation-draft-guidelines-for-medication-review 

US FDA published final guidance on “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry”

Date of news: July 27, 2022

The objective of this guideline is to applicants of INDs, NDAs, BLAs, and supplements to these applications planning to carry out neonatal populations’ clinical studies. 

This document does not discuss the timing to start neonatal studies. This sponsor should discuss this topic with the relevant FDA review division.

Source: https://www.fda.gov/media/129532/download 

News on EDQM website “General chapter 2.2.46. Chromatographic separation techniques now published in Ph. Eur. 11th Edition”

Date of news: July 27, 2022

General chapter 2.2.46. Chromatographic separation techniques have been revised to include the provisions of the pharmacopoeial harmonization text agreed by Pharmacopoeial Discussion Group (PDG) on 28 September 2021. The revised chapter is now available in the 11th Edition of the Ph. Eur. (Effective date: 1 January 2023).

This general chapter applies to TLC, GC, LC and SE.

The key changes made to harmonize text are related to:

  • Signal-to-noise ratio;
  • The default symmetry factor range;
  • Update on retention times and relative retentions;
  • The system repeatability requirement for assay of active substances and excipients;
  • For isocratic elution, adjustment of the stationary phase are stricter than in the former chapter;
  • For gas chromatography, harmonization of the conditions for adjustment of the  injection volume, column dimensions, injection port, split ratio, and transfer-line temperatures;
  • Deleted the adjustments for supercritical fluid chromatography.

Source: https://www.edqm.eu/en/-/general-chapter-2.2.46.-chromatographic-separation-techniques-now-published-in-ph.-eur.-11th-edition 

TGA updated nitrosamine impurity related information with respect to manufacturing requirements

Month of news: July 2022

The agency has updated the details on nitrosamine impurities for applicants and manufacturers. The updated version of information has a list of acceptable intake limits for different nitrosamines from animal carcinogenicity studies. 

Few limits are derived from studies and others are extrapolated from closely related nitrosamine compounds. For more details, refer to the following link.

Source: https://www.tga.gov.au/alert/nitrosamine-impurities-medicines-information-sponsors-and-manufacturers

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