“good laboratory practice - ipapharma.org. raghunandana… · what is good laboratory practice...

“Good Laboratory Practice”“Good Laboratory Practice”Good Laboratory PracticeGood Laboratory PracticeHow Critical to QualityHow Critical to Quality

R RaghunandananR RaghunandananR RaghunandananR Raghunandanan

MumbaiMumbai

55thth June 2015June 2015

05‐June‐2015 [email protected] 1

Good Laboratory Practicey

Scope of this session

GLP from a Regulatory perspectiveGLP from a Regulatory perspective

GLP from a Quality System perspective


IntroductionIntroductionIntroductionIntroduction


What is Good Laboratory Practice–GLP is NOT just some good practices in a LaboratoryLaboratory

–GLP is a Quality System concerned with the organizational process and the conditions o ga at o a p ocess a d t e co d t o sunder which laboratory studies are –• Planned, Performed and Monitored ,• Recorded, Reported and Archived

– Thus GLP covers the whole gamut ofThus GLP covers the whole gamut of Laboratory Processes


Why Good Laboratory PracticeWhy Good Laboratory Practice

• The purpose of GLP is to ‐

– Ensure quality test data

– Ensure sound laboratory management– Ensure sound laboratory management

– Ensure robust conductance of laboratory t titesting

– Ensure accurate reporting of test findings

– Ensure safe archival of laboratory data


Laboratory Data Integrity Data integrity is very critical ‐ Analytical results shouldshould

Accurately describe the properties of the samples assessedsamples assessed

Permit correct conclusions to be drawn about th lit f th lthe quality of the samples

Form the basis for any subsequent administrative and legal actions

Form the basis for any customer responses


y p

Laboratory Data l b lGlobal Acceptance

L b t d t i t it h i t t• Laboratory data integrity has an important international dimension

Gl b l t f C f AGlobal acceptance of C of ADuplicative testing can be avoided C t d t ti d i d tCosts saved to nation and industryFaster disposal of registration submissions


GLPGLPCompliance PerspectiveCompliance Perspective


Good Laboratory PracticeCompliance requirements

• The Drugs and Cosmetics Act 1940The Drugs and Cosmetics Act, 1940

– Schedule L‐1 on GLP effective Nov 2010

S h d l S i Q li– Schedule M ‐ Section 14 on Quality Assurance and Section 16 on Quality Control mentions b GLPabout GLP

– Schedule U Part III – Particulars to be recorded in Analytical Records pertains to GLP


Good Laboratory PracticelCompliance requirements

• 21 CFR Part 211, US FDA cGMP

– Subpart I, Laboratory Control – stipulates p , y pdetailed laboratory controls to be followed

05-June-2015 [email protected] 10

Good Laboratory PracticeCompliance req irementsCompliance requirements

• EU GMP EudraLex Volume 4 Part 1 updatedEU GMP EudraLex Volume 4, Part 1, updated version effective Octb2014

Chapter 6 Quality Control–Chapter 6 – Quality Control

–Mentions Good QC Laboratory Practice, i l d il d lstipulates detailed control measures

• Recent Guideline from MHRA on Data Integrity essentially deals with GLP


Good Laboratory PracticeCompliance req irementsCompliance requirements

• WHO GMP GuidelinesWHO GMP Guidelines

– TRS 957 Annex 1 – WHO Good Practices for Pharmaceutical QC LaboratoriesPharmaceutical QC Laboratories

– TRS 961 Annex 2 – WHO Good Practices for Ph i l Mi bi l L b iPharmaceutical Microbiology Laboratories

• Other statutes and Guidelines like ICH Q7


Good Laboratory PracticeCompliance requirements

• Thus compliance is mandated• Thus compliance is mandated

• Compliance is essential ‐– For patient safety primarily

–Meeting regulatory expectationsMeeting regulatory expectations

– For high level of customer confidence

In dealing ith an f t re litigations– In dealing with any future litigations


GLPGLPQ li S P iQ li S P iQuality System PerspectiveQuality System Perspective


OrganizationOrganization


Organizationg• Management responsibility

D fi i L b ’ l d–Defining Laboratory manager’s role and responsibilitiesI d d f l b f i (QC&QA)– Independence of laboratory function (QC&QA)

–GLP compliance must be referred to in the Q li M lQuality Manual

–Making resources available –Controls on external testing labs if any–Use of metrics related to laboratory operations


Laboratory Facilities (1)Laboratory Facilities (1)


Laboratory Facilities (1)Laboratory Facilities (1)

• A factor that is overlooked in many organizationsy g

• Effective and accurate laboratory activities possible only if adequate space is providedpossible only if adequate space is provided

• Adequate space includes – sample receiving and storage areas testing areas chemical storagestorage areas, testing areas, chemical storage areas, glassware washing areas, office areas, retention sample storage areas documentretention sample storage areas, document storage areas, training room etc.


Laboratory Facilities (2)Laboratory Facilities (2) • Logical workflow to avoid crisscross movements

• Crisscross movements kills productive man‐hours in the laboratoryy

• Consider space requirements 10 years ahead and make provisionsand make provisions

• Apply principles of Lean Lab


Personnel and trainin (1)Personnel and training (1)


Personnel and training (1)Personnel and training (1)

• People make or break the GLP systems

• Getting qualified and experienced analysts with the right attitude is a challenge todaywith the right attitude is a challenge today

• Responsibilities should be defined, communicated and documented to avoidcommunicated and documented to avoid overlapping


Personnel and training (2)Personnel and training (2)

• Mere training is not enough

• Organizations should have development plans for the laboratory staff – that only can helpfor the laboratory staff that only can help retain them

• Talent identification and development plans• Talent identification and development plans

• Succession plans should be in place


Personnel – How crucial they are ?Personnel How crucial they are ?

Good facility + Good systems + Right people = Good product

Average facility + Good systems + Right g y y gpeople = Good product

Average facility + Average systems + RightAverage facility + Average systems + Right people = Good product (still possible)

Good facility + Good systems + Not the rightGood facility + Good systems + Not the right people = Poor product


Laboratory Equipment (1)Laboratory Equipment (1)



• Science and technology progressed several folds during the last decades

• Automation is the answer for many of theAutomation is the answer for many of the laboratory illness

• Ideally all needed equipment should be• Ideally all needed equipment should be available

O t i t t l if j tifi d• Outsourcing any tests only if justified



• Equipment qualification calibration andEquipment qualification, calibration and maintenance

• Controls on computerized systems in line with• Controls on computerized systems in line with 21CFR Part 11 and EU GMP Annex 11

A id d i i b h i l i• Avoid data integrity breaches involving computerized systems in the laboratory by h i b lhaving robust controls


Chemicals and reagentsChemicals and reagents


Chemicals and reagentsChemicals and reagents

• Chemicals, reagents and reference substances pay a vital role in the correctness of laboratory results

• Microbiological cultures and media

• Traceability in all recordsTraceability in all records

• Uncontrolled cost cutting in this area could lead to increased number of laboratorylead to increased number of laboratory deviations and OOS results


Sampling and TestingSampling and Testing



• Sampling is a critical activity

• Sampling should be done by trained personnel

• Sample identification, samples controls andSample identification, samples controls and sample disposition should be as per written proceduresprocedures

• Sampling of stability samples as per written procedures for stability testingprocedures for stability testing



• Pharmacopoeial test procedures should be verified

• Other test procedures should be validatedp

• Concurrent recording of test results

• Trending of test results• Trending of test results

• Stability testing as per written procedures


Laborator Doc mentation (1)Laboratory Documentation (1)


Laboratory Documentation (1)Laboratory Documentation (1)

• Documentation is key to the laboratoryDocumentation is key to the laboratory process

• Laboratory documentation – Manual system,Laboratory documentation Manual system, electronic system or a hybrid system

• Robust controls for original raw data andRobust controls for original raw data and traceability

• Secured storage of documentsSecured storage of documents


Laboratory Documentation (2)Laboratory Documentation (2)

• Equipment qualification documentsEquipment qualification documents

• Method validation documents

h d f d f &• Method transfer documents from R&D

• Method transfer documents from other labs

• Test reports and Certificates of Analysis


Out of Specification Investigations (1)


Out of Specification Investigations (1)Out of Specification Investigations (1)

• Management of OOS results need special mention

• OOS and atypical results arise due toOOS and atypical results arise due to

– Laboratory error

O t–Operator error

–Process related error (usually in mfg.)

–Material related errors

– Environment related factors o e t e ated acto s


Out of Specification Investigations (2)p g ( )

• Robust investigations process

• Identification of root cause

• Trending of OOS results• Trending of OOS results

• CAPA process


S lf I tiSelf Inspection


Self Inspectionp

• One of the strongest tools for continual improvement if done diligently

–Cover all laboratory areas and systemsy y

– Issue report as soon as possible

Get CAPA commitments and put CAPA–Get CAPA commitments and put CAPA tracking system in place

Fi di di d i t i– Findings discussed in management review meetings


Self Inspection p

Level 4External Regulatory bodies

Level 3 auditsCorporate Audits

Audits

Corporate Quality

Level 2 audits Internal audits

o po

Inter‐dept.

Level 1 auditsSelf inspection Intra‐dept.


Good housekeeping &Good housekeeping & Laboratory Safety


Good housekeeping & b fLaboratory Safety

• Good Housekeeping and safety go hand in hand• Good Housekeeping and safety go hand in hand

• Employee safety, personnel protective iequipment

• Laboratory garment regime and contamination control

• Equipment and facility safety; fire hazards q p y y


Ri k A t i L b tRisk Assessment in Laboratory


Risk Assessment in LaboratoryRisk Assessment in Laboratory

• Identifying risks in laboratory operations is business critical

• Still this is an area seldom addressed by theStill this is an area seldom addressed by the industry

• Lack of knowledge and / or lack of• Lack of knowledge and / or lack of commitment

M bl ld h b id d if• Many a problem could have been avoided if a robust Risk Assessment process was in place


MyMessageMy Message


MessageMessage

• Patient safety and regulatory compliance arePatient safety and regulatory compliance are of paramount importance for pharma laboratory operationslaboratory operations

• Key decisions about the product are made in the Laboratorythe Laboratory

• Without robust laboratory controls the patient d b i b h ill ffand business both will suffer


MessageMessage

So as an Analyst you have a dual roleSo as an Analyst you have a dual roleSo as an Analyst you have a dual roleSo as an Analyst you have a dual role

•• Help the patientHelp the patient

•• Help the businessHelp the business

•• Then only you can help yourselfThen only you can help yourselfThen only you can help yourself Then only you can help yourself

•• Good luck to you!Good luck to you!


Thank YouThank YouThank YouThank You


“good laboratory practice - ipapharma.org. raghunandana… · what is good laboratory practice...

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