Pharma GMP News of the Week: 11-July-2021

Period: July 1, 2021 to July 10, 2021

Data Integrity Document published by PIC/S: 1 July 2021

Name of Guideline: PI 041-1 “Good Practices for Data Management and Data Integrity in regulated GMP/GDP Environments

There are 14 chapters in the guideline. The document covers important aspects of Data governance system, Organisational influences on successful data integrity management, General data integrity principles and enablers, Specific data integrity considerations for paper-based systems, Specific data integrity considerations for computerised systems, Data integrity considerations for outsourced activities.

Most importantly, it also covered what would be the Regulatory actions in response to data integrity findings and how to remediate the situation of data integrity failures.

Key Points in the guideline:

  • Discussed about all activities related to the handling of data, data policy, documentation, quality and security.
  • Data management related to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The scope also covers documents related to registration dossier.
  • On-site and remote, or desktop, inspections.
  • The concept of the data lifecycle, starts from data generation, processing, reporting, checking, data used for decision-making, storage and disposal at the end of the retention period.
  • Data governance controls.
  • Company culture and its integration with data integrity plan.
  • Approach regarding non-hierarchic management structure and top-down structure.
  • General data integrity principles and “enablers” that help put the principles into operation.
  • ALCOA and ALCOA++ for both, paper and electronic systems.
  • Specific elements checking during a record review, and expectations for generation, distribution and control of records.
  • Expectations and potential risks in qualifying computer systems.
  • System security issues such as user access controls.
  • Data integrity within hybrid systems.
  • Hybrid systems are discourages to use because of their complexity and potential increased vulnerability to manipulation of data.
  • Data integrity related to outsourcing activities.
  • Potential regulatory actions that may be taken in response to deficiencies or other data integrity findings.

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry issued by US FDA, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research: July 2021

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain drug master files (DMFs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs) submitted to the Center for Drug Evaluation and Research (CDER) or to the Center for Biologics Evaluation and Research (CBER).

Source: www.fda.gov

Revised general chapter 5.21 Chemometric methods applied to analytical data published for public comment in Pharmeuropa: July 2021

The revised general chapter Chemometric methods applied to analytical data (5.21) has been published in this quarter’s issue of Pharmeuropa (33.3), the European Pharmacopoeia (Ph. Eur.) online forum, for comment. The deadline for comments is 30 September 2021.

This general chapter, published for information, is an introduction to the use of chemometrics and data science techniques. The objective is to provide indications on good practice and requirements for the processing of analytical data.

The chapter is rewritten. Key point includes:

  • Updated Section 1. General aspects with a review of parts on Pre-processing (1.2.2.6) and Assessment and validation of chemometric methods (1.3);
  • New subsections added:
    • Independent component analysis (2.2)
    • Decision trees and random forests (2.6);
  • Review of sub-sections on:
    • Similarity measures (2.3)
    • Clustering (2.5)
    • Multiple linear regression (2.8)
    • Principal component regression (2.9)
    • Support vector machines for supervised classification (2.11)
    • Artificial neural networks (2.12);
  • New section added:
    • 3. Related application fields, covering sub-sections on Chemometrics in chemical imaging (3.1)
    • Data fusion (3.2);

Source: https://www.edqm.eu/en/news/revised-general-chapter-521-chemometric-methods-applied-analytical-data-published-public

Pharmeuropa 33.3 released: 05 July 2021

All new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. 

The deadline for comments on Pharmeuropa 33.3 is 30 September 2021.

Source: https://www.edqm.eu/en/news/pharmeuropa-333-just-released

Cleaning validation guide (GUI-0028) revised by Health Canada: Published on June 29, 2021

This document provides guidance on cleaning validation. It will help user to understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations).

This guide addresses special considerations and issues when validating cleaning procedures for equipment used to fabricate and package of Active Pharmaceutical Ingredients (APIs), Pharmaceuticals,

Radiopharmaceuticals, Biological drugs, and Veterinary drugs.

It covers validation of equipment cleaning for the removal of residues associated with products used in the previous production run, such as active ingredients, breakdown or by-products of concern, intermediates, residues of cleaning agents, and processing agents the control of potential microbial contaminants

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/cleaning-validation-guidelines-guide-0028.html

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