Scribd
Upload
389 views3 pages

GMP Failure Investigation

The document outlines a three-phase process for conducting GMP failure investigations when an out-of-specification result is detected: Phase 1 involves an initial investigation by analysts and supervisors, Phase 2 expands the investigation to manufacturing if the root cause is not found, and Phase 3 aims to identify the most probable root cause and implement corrective actions. The goal is to ensure effective and reliable products for patients by reducing errors and preventing recurring quality issues.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
389 views3 pages

GMP Failure Investigation

The document outlines a three-phase process for conducting GMP failure investigations when an out-of-specification result is detected: Phase 1 involves an initial investigation by analysts and supervisors, Phase 2 expands the investigation to manufacturing if the root cause is not found, and Phase 3 aims to identify the most probable root cause and implement corrective actions. The goal is to ensure effective and reliable products for patients by reducing errors and preventing recurring quality issues.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 3

GMP Failure Investigation: Identifying

and Fixing the Root Cause


The Code of Federal Regulations (21 CFR 820) expects the drug manufacturers to

conduct an immediate failure investigation when the product is reported in Out-of-

Specification (OOS) category. Remember that OOS is not product failure, it is just a

deviation from the specified test results. It may occur due to one of the following reasons

– laboratory error, non-process related error, process related error. GMP failure

investigation is also a fair business practice which reduces the rework and eliminates the

recurring quality issues.

Above all, investigating into GMP failure ensures that the patients get an effective and

reliable product. The failure investigations are conducted in following stages.

GMP Failure Investigation in three phases

GMP Failure Investigation: Phase 1

As soon as the analyst detects an OOS result, makes a mistake in performing analysis,

uses incorrect standards or miscalculate the data, they should immediately inform their

supervisor about the issue. The supervisor works with the analyst to conduct an

investigation. If no apparent reason for the OOS result was found, the supervisor reports

to it to the quality assurance department within a specified period, generally 24-48 hours.

This is when begins the formal investigation with an attention to corrective action. The

company must have a clearly descried SOP for the area or the process where the incident

occurred.
At this stage, a checklist is developed to identify the sources of the error that could have

occurred in any place- sampling, handling, method validation, instrument performance,

method validation, test procedure, etc.

The level of investigation depends upon complexity of the problem. Sometimes, it may

require an in-depth investigation, other times, it’s perfectly fine to go ahead with the

simple trend analysis and other acceptable tools. The analyst and supervisor determine

whether the out-of-specification results should be assigned to a testing laboratory.

In case, the issue is assigned to a testing laboratory, it performs the test for original

samples again. If the results of testing laboratory meet the acceptance criteria, the

company invalidates original OOS result. All the procedures and root causes are

documented. The quality assurance department comes up with corrective measures to

save the batch and prevent such recurrences in future.

GMP Failure Investigation: Phase 2

First phase was based on the condition that testing laboratory successfully identifies the

root cause of out-of-specification results reported. What if it couldn’t? All the reasons,

justifications, evaluation criteria, SOPs and other protocols are documented. If the cause

of the OOS could not be identified, an investigation of the manufacturing process is

warranted. If no manufacturing error is reported and the quality assurance department has

sufficient data obtained from retests and product history to decide that the original OOS

error was due to the unassignable laboratory error, then the department concludes that

this OOS result is not representative of the batch.


At this point, other batches, equipments and manufacturing processes are also assessed.

GMP Failure Investigation: Phase 3

Primary objective of the last phase of investigation is to recognize the most probable

cause of the OOS result. In case, laboratory testing was identified as the primary cause,

the company should consider retraining its employees and/or apparatus maintenance. The

final report specifies testing procedures, validated processes and people responsible for

taking corrective actions to prevent the recurrence of such events.

Entire failure investigation process must be completed within a predefined time period,

usually 20 working days. If completion of failure investigation is not possible within this

timeline, FDA requires companies to present a valid justification.

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy