glp talk pg 15.pdf

8/20/2019 GLP talk PG 15.pdf

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GLP GMP: The purpose o

8

th

June2015

m.gauci@

Week 4 lab skills course for Project Students

mailto:[email protected]

mailto:[email protected]



What is GLP/GMP?

• MHRA definition of GLP:

• Good Laboratory Practice (GLP) embodies a set of principles thata framework within which laborator

y studies are planned, performonitored, recorded, reported and archived. These studies are uto generate data by which the hazards and risks to users, consumthird parties, including the environment, can be assessed for

pharmaceuticals (only preclinical studies), agrochemicals, cosmeadditives, feed additives and contaminants, novel foods, biocidesdetergents etc.... GLP hel

ps assure regulatory authorities that thsubmitted are a true reflection of the results obtained during theand can therefore be relied upon when making risk/safety assess



In short…

• GLP – not to be confused with lab safety and more than just a lab

•

Good Laboratory Practice (GLP) and Good Manufacturing Practiceemployed in parallel.

• GLP refers to a set of principles and practices that ensure the accutraceability and reproducibility of the results obtained in the lab.

• “What has not been written, has not been done”

• GLP covers all the aspects; from experimental design, method valiperforming the analysis, training of personnel, documentation anrecords.



GMP or Good Manufacturing Practice in sho

• A set of principles and practices that the ENTIRE MANUFACTURINmust adhere to (including labs). These guidelines provide minimu

that a pharmaceutical or a food product manufacturer must meetthe products are of high quality and do not pose any risk to the copublic. It is a system to ensure that the products meet the qualityrequirement.

• Include the use of high quality raw materials, in-process testing &use of validation batches, controlled conditions in production area

to deal with complaints and possible re-calls.

• These principles and practices are required to CONFORM TO GUIDregulatory agencies that control the licensing and manufacture ofAg

encies deem products fit and safe for human consumption andmarketing of the medicine.



10 Principles of GMP video

•

https://www.youtube.com/watch?v=JHkGgFUuZwE







Who needs GLP/GMP?



Why do we need GLP / GMP?

•MONEY!(and safety)



Workflow in a Pharma Biotech compan

Pharma/Biotech companyconducts all the necessary

research, bioanalytical,PD, PK and toxicology andstability tests for a drug

Regulatory agencythoroughly investigates

the information provided.If deemed safe issues

marketing authorization

to sell the drug.

Once approvedcompany can themarketing the dlocal or even fo

bodies. “Laun

Testing Licensing Marketing

The lab book is a legal document:

It is a record of the work carried

out by the company and its

employees as evidence for patent

filing and protection.

Audits will be carried out to ensure the

accuracy, reliability, originality and

traceability of the results, so the

information contained in a lab book must

be able to withstand any challenges to its

validity or accuracy.



Have there been instanceswhen data presented by a

company was false?



In 2005, Thakur blew the whist

investigation found Ranbaxy ha

pattern" of submitting "untrue

least 15 new generic drug appli

found over 1,600 data errors. T

that their drugs were "potentiato sell."

Drug and vaccine manufacturer Merck

was caught red-handed by two of its own

scientists faking vaccine efficacy data by

spiking blood samples with animal

antibodies.

GlaxoSmithKline has just be

a whopping $3 billion for b

doctors, lying to the FDA, h

clinical trial data and fraud

marketing.

IBT was criminally implicated in 1977 for producing fraudulent

studies on widely used household and industrial products,

including Nemacur, Sencor, Naprosyn, and trichlorocarbanilide.The magnitude of IBT's scientific misconduct was considered to

have been extensive: 618 of 867 (71%) of studies audited by

the FDA were invalidated for having "numerous discrepancies

between the study conduct and data. Consequently, IBT would

later be described as being "at the centre of one of the most

far-reaching scandals in modern science, as thousands of its

studies were revealed through EPA and FDA investigations to

be fraudulent or grossly inadequate."



GLP Mantra : ‘Fool Proof’ framework

• Traceability: “What has not been written has not been done”

• Law suit mind-set : Is my lab book law suit proof?

• Are there any missing/torn pages?

• Are all my mistakes clearly crossed out, signed and dated?

• Can it be subject to later manipulation?



The lab book…

• The GLP lab notebook provides a permanent record of the researesults and observations carried out by a company and a signed Gis legally binding.

• Every result obtained on each test carried out on the new medicpart of the Intellectual Property (IP) rights of the company

• Thus, it is a legal record of the work carried out by the company

employees as evidence for patent filing and protection.

• Audits will be carried out by regulatory agencies to ensure the acreliability, originality and traceability of the results, so the informcontained in a lab book must be able to withstand any challenge

or accuracy.



GRP?• Or Good Research Practice is increasing in popularity.

•Publications are now asking for even more raw data and evidence thatexperiments were performed correctly, are accurate and valid, even hipanels of experts to review all the experiments performed.

• Especially when dealing with patient samples, traceability is key, along ethics and the highest professional standards.

• This avoids fund misuse, publishing inaccurate research(and thus generating unfounded public fear) putting the Journal’s reputhe line.



Non-GLP lab book examples

• See if you can identify any non-GLP elements in the following exand what risk they carry.

• Highlight also the ‘positives’.



R f



References

• Adams M. (2012). Big Pharma criminality no longer a conspiracytheory; Bribery, fraud, price fixing now a matter of public record.Available:http://www.naturalnews.com/036417_glaxo_merck_fraud.htmlaccessed 13th Oct 2014.

• Miller J., Strickler L.,Gaynor J. (2013). Leading generic drug make faked results for FDA approval . Available:http://www.cbsnews.com/news/leading-generic-drug-maker-faktest-results-for-fda-approval/ . Last accessed 13th Oct 2014.

• New Scientist . (2014). Browse jobs . Available:http://jobs.newscientist.com/en-gb/jobs/. Last accessed 13th Oc2014.

• Stock images from Wikimediahttp://commons.wikimedia.org/wiki/File:Putting_money_into_a

ybank.jpg Last accessed 14 Jan 2015

http://commons.wikimedia.org/wiki/File:Putting_money_into_a_piggybank.jpg




glp talk pg 15.pdf

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