Category: quality intelligence

Attributable within a Process

Attributable is part of ALCOA that tells us that it should be possible to identify the individual or computerized system that performed the recorded task. The need to document who performed the task / function, is in part to demonstrate that the function was performed by trained and qualified personnel. This applies to changes made to records as well: corrections, deletions, changes, etc.

This means that records should be signed and dated using a unique identifier that is attributable to the author. Where author means the individual who created or recorded the data.

Understanding what role the individual is playing in the task is critical. There are basically six: Executor, Preparer, Checker, Verifier, Reviewer and Approver.

The Six Primary Roles

Interpreting Q7

The latest version (version 14) of the “How to do” Document – Interpretation of ICH Q7 Guide and “Review form” for APIs was published a few months back. It is intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on interpretation.

In this version, the responsible Task Force of the Quality Group of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), mainly made additions and updates in chapters 11 –  Laboratory Controls, 15 – Complaints and Recalls, and in section 16 – Contract Manufacturers (incl. Laboratories).

The addition in section 11.11 for “Approval/rejection of materials” is pretty striaghtforward – have an SOP.

The changes in section 15 for recalls is pretty cosmetic.

I would re-read section 16 on contract manufacturers. Not much substantial here, but the rewrite makes it a good time to ensure compliance.

MHRA on Good Pharacovigilance Inspections

The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020. 

Someday these reports won’t take a year to write. If I took a year writing my annual reports I would receive an inspection finding from the MHRA.

There is no surprise that the five critical observations are all from risk management. Risk management is also the largest source of major findings, with quality management a close second with a lot of growth.

There are a lot of observations around the smooth and effective running of the CAPA program; a fair amount on PSMF management; and a handful on procedure, training and oversight.

Looking at the nine major observations due to deficiencies in the management of CAPA, the MHRA reports these problems:

  • Delays to CAPA development
  • CAPA that did not address the root cause and impact analysis for the identified noncompliance
  • Open CAPA which were significantly past their due date
  • CAPA raised from a previous critical finding raised at an earlier MHRA inspection had not been addressed

I’m going to go out on a limb here and say some of these stem from companies thinking non-GMP CAPAs do not require the same level of control and scrutiny. Root Cause Analysis and a good CAPA program are fundamental, no matter where you fall on (or out of) the pharmaceutical regulatory spectrum.

PIC/S on Inspection of biotech manufacturers

PIC/S recently updated an Aide Mémoire on inspections of biotech manufacturers in January. The aim of this AiM is to harmonize GMP inspections in biotechnological and biological facilities and to ensure their quality. There wasn’t much new in this version, the revision history says “Minor edits to update cross-references to PIC/S GMP Guide (PE 009-14),” but this is a good time to review the document.