Online Safety Community

Are Your Test Methods Ready for Quality Control or any laboratory ?

The FDA considers verification and transfer of Test Methods a subject worthy of 483 observations and issuance of Warning Letters. Test method verification is also required by the GMPs, and USP has a whole chapter dedicated to test method verification. This makes comprehension of the requirements for the verification and transfer of a test method into a laboratory imperative for Laboratory Managers and other personnel.

In normal circumstances, the requirement for method transfer arises with the transfer of the method from the Method Development environment to the routine Quality Control testing laboratory. Ideally, however, the existence of method transfer any time a method is transferred from one laboratory to another should be in place, as this would also address and include the transfer of the method into more environments, such as a stability testing laboratory, or a contract laboratory or the testing laboratory of a contract manufacturer.

Support for verification of test methods

The US GMPS requires the verification of test methods under actual conditions of use to verify the suitability of all testing methods. The USP seconds this, stating that “Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use”.

The concept of method verification is also supported by a modified version of the accepted definition of test method validation, which requires documented evidence to ensure “that the test method performs as intended in the using laboratory”.

So, what does this mean for laboratories that have not performed the test before? Such firms must demonstrate something to prove that the test method performs as intended. This has to be done irrespective of whether the transfer is from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. All that is needed for the firm is to demonstrate that the receiving laboratory has the capability to perform the test, and also that the test results are an accurate reflection of the attribute being tested.

A learning session on method transfer and method verification

However, many companies do not understand what should be done for a thorough, successful test method transfer. A webinar from Compliance4All, a highly respected provider of professional trainings for all the areas of regulatory compliance, will explain all the intricacies of method transfer and method verification.

At this webinar, Jerry Lanese, an independent consultant with a focus on Quality Systems and the components of an effective Quality System, will be the speaker. In order to understand the complete nitty-gritty of method transfer and method verification, please register for this valuable webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501282L...

The term method verification acquired a new shape and meaning with the USP’s publication of its stimulus article on the test method lifecycle. This stimulus article proposes Continued Test Method Verification during stage 3 of the test method lifecycle. At this webinar, Jerry will discuss test method verification and what all need to be considered for the method verification project.

This learning, on all areas of method transfer and method verification, will be extremely useful and valuable for Laboratory Directors, Managers, Supervisors and Analysists in any laboratory performing GMP testing.

At this session, Jerry will cover the following areas:

o  The requirements for test method verification when a method is transferred from one laboratory to another

o  What might be included in the method verification that accompanies a test method transfer?

o  The regulatory and compendial expectation for test method verification as a part of the test method lifecycle

o  What might be included in continued test method verification?

Views: 22

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Roger Steven posted a blog post

Differences between Device and Drug Clinical Research

Medical devices and drugs clinical research have their differences in approach and methodology. It is necessary to have a clear understanding of these differences if one embarks upon a study involving either or both of these.Some of the major differences between device and drug clinical research include:Requirement for a study:One of the important differences between device and drug clinical research relates to the…See More
7 hours ago
Adam Fleaming posted a blog post

Philippine anti-drug agency chief vows 'rule of law'

The new chief of the Philippines’ anti-drug agency has promised a fresh approach to the controversial war on drugs, “based on the rule of law”.Aaron Aquino said that since he took over in August, only one suspect had been killed in 1,341 operations.Thousands have died in the anti-drug campaign since it was launched by President Rodrigo Duterte in 2016.Rights groups say Mr Duterte has sanctioned extrajudicial killings by vigilantes and by police.…See More
8 hours ago
John Robinson posted blog posts
8 hours ago
Training Doyens updated an event
Thumbnail

How to Prepare and Survive an OSHA Audit at 26468 E Walker Dr, Aurora, Colorado 80016-6104

January 23, 2018 from 1pm to 2pm
OVERVIEWRegulatory Compliance Audits can be taxing and worrisome for anyone.  Having an OSHA Audit open an organization up to receiving regulatory citations, monetary fines, negative company press, etc.  The purpose of this OSHA compliance training is to cover the key concepts of how to successfully navigate through an OSHA Audit.  Being prepared ahead of time and knowing the right protocols can help turn a negative situation of being involved in a compliance audit into a positive one.WHY…See More
11 hours ago

Forum

Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe Nov 16.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells Nov 15.

What's your favorite motivational/safety quote? 102 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins Nov 14.

Business Intelligence with Big Data happens at Unipê

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

Tags: qliksensetraining, qliksenseonline, qliksense

Started by Soujanya Naganuri Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Barry Oct 26.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service