Good

Laboratory
Practice
August 2013

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 Good Laboratory Practice

• Scope of this training is limited to Quality

Control Laboratories
– Chemical

– Instrumental

– Microbiological

– Packaging material testing

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 Good Laboratory Practice
• What is GLP
– Not just good practices in a Laboratory !!
– Good Laboratory Practice is a quality system concerned with the
organizational process and the conditions under which laboratory
studies are –
• Planned
• Performed
• Monitored
• Recorded
• Archived
• Reported

Thus GLP covers the whole gamut of

Laboratory Processes
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 Good Laboratory Practice

GLP in the laboratory, with GMP in

manufacturing and related functions,

gives assurance of product quality

up to the time of usage by the consumer

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 Good Laboratory Practice
• The purpose of GLP is to –
– Ensure sound laboratory management
– Ensure robust conductance of laboratory
testing
– Ensure accurate reporting of test findings
– Ensure safe archival of laboratory data

All for assuring Product Quality & Safety

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 Why Laboratory Testing

 Input material controls

 Identity of each items
 Purity of each items
 Freedom from impurities
 Freedom from contamination
 Regulatory compliance

 Also helps in identifying

 Trend of supplies during product reviews
 Uniformity in supplies
 Supplier performance reviews

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 Why Laboratory Testing

 In Process Controls
 Process progress
 Reaction completion
 Regulatory compliance

 Also helps in
 Early warnings on process progress
 Manufacturing trends
 Process capability studies
 Validation reviews

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 Why Laboratory Testing

 Finished products controls

 Compliance to registered specifications
 Purity and identity established
 Stability assured till end of life
 Assurance to customer on quality and efficacy
 Mandated regulatory compliance

 Also helps in
 Manufacturing trends
 Product reviews
 Process capability studies, validation reviews

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 Good Laboratory Practice
Compliance requirements
The Drugs and Cosmetics Act, 1940
 Schedule M - Section 14 on Quality Assurance
mentions about GLP without much details
 Schedule M - Section 16 on Quality Control Unit
covers several points that are part of GLP
 Schedule U Part III – Particulars to be recorded in
Analytical Records
 New Schedule I on GLP being incorporated

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 Good Laboratory Practice
Compliance requirements

• Thus compliance is mandated

• Compliance essential -
– For consumer/patient safety primarily
– Meeting regulatory expectations
– For high level of customer confidence
– In dealing with any future litigations

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 Users and Customers of Analytical Methods

BP/EP/USP/IP Literature
Application
Method Transfer
Selection

Validation
Product(ion)
Development Quality Control Control

Regulatory
Affairs

Regulatory
Bodies
 Good Laboratory Practice
Main elements

• Resources
– Organization
– Personnel and training
– Facilities
– Equipment
– Chemicals and reagents
• Documentation
– Procedures (MOAs and SOPs)
– Specifications
– Raw test data
– Log books
– Final reports and C of A
– Archival

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 Good Laboratory Practice
Main elements

• Systems
• Analytical Equipment Validation
• Equipment Calibration
• Analytical Method Validation
• Out of Specification Investigations
• Internal audits
• Good housekeeping & Laboratory Safety

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 ORGANIZATION

Management responsibility
 Define R&R

 Independence of laboratory function (QC & QA)

 must be referred to in the Quality Manual

 Appropriate budgets

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 Personnel and training

• Adequate in number

• Suitably qualified and experienced

• Approved by the regulatory bodies (expert staff, QP

etc.)

• Responsibilities defined, communicated and

documented

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 Personnel and training
• Suitably trained and re-trained periodically
– Training needs identified

– Schedules drawn up

– Training materials made

– Assessment done

– Records maintained

• Right attitude and team spirit

• Rotated in all sections for flexibility

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• Succession plans in place
 Laboratory Facilities
• Should be conveniently located, segregated from
production

• Minimum internal and external traffic to ensure quiet

environment

• Adequately spaced – sample receiving areas, testing

areas, utility areas like water, steam and gases, office
areas, sample storage areas, document storage areas
etc.

• Logical workflow to avoid crisscross movements

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 Laboratory Facilities

• Instrument rooms separated from chemical lab, Incubations

rooms and cold rooms

• Microbiology laboratory should be separate

• Packaging material testing lab near warehouse

• Bulk chemical and solvent storage areas separate from lab

• Flame proof areas for bulk storage of solvents

• Hot rooms for gas burners and furnaces

• Glassware washing areas

• Meeting rooms, library

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 Laboratory Facilities
• Adequate lighting and ventilation

• Air-conditioning of instrument rooms

• Floors, walls and ceiling smooth, easy to clean

• Table tops resistant to acids, alkalis and solvents e.g. ss, glass,
melamine etc.

• Service lines to be colour coded

• Fumes extraction systems should be provided

• Safe storage areas for poisonous substances

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 Laboratory Equipment

• Ideally all needed equipment should be available

• Outsourcing any tests should be justified

• Instruments and other equipment serviced periodically and

calibrated as per schedules

• Replacement policy available

• Budgets available for replacement and maintenance

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 Laboratory Equipment

• All equipment identified, status labeled

• Instrument Operations Procedures and Calibration procedures

in place

• Log books for each instrument in place

• All Volumetric wares must be calibrated or manufacturer’s

certificate obtained

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 Chemicals and reagents
• All chemical and reagents must be labeled
• Volumetric & other standard solutions must have
– Date of preparation
– Use before date
– Initials of the person who made
– Batch number
• Do not return unused volumetric solutions to bulk
• Use only distilled water or water meeting IP
requirements for reagent preparation
• Date of receipt of chemicals should be indicated on
containers

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 Chemicals and reagents

• Reference standards, microbiological cultures and

culture media handled with special care

• Traceability for all standards and reagents

• Availability of cold cabinets, refrigerators with

temperature monitors

• Material Data Sheets for all chemicals

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 Documentation
Specifications and Procedures

• Documentation cell preferred

• Manual system or LIMS
• Periodically updated, circulation controlled
– Specifications
– Methods of testing for RM, PM and FP
– Sampling procedures
– Sample logs
– Standard Operating Procedures
– Instrument Operating Procedures
– Instrument logs

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 Documentation
Specifications and Procedures
• Analytical equipment validation documents

• Analytical method validation documents

• Method transfer documents from R&D

• Test reports and Certificates of Analysis

– Meet customer country regulatory requirements

– Traceability and cross references as required

– Explicit comments by the Lab In-charge

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 Documentation
Raw Test Data

• Raw test data means

– All original test records like weights, calculations etc.
– Handwritten notes if any
– Computer and other printouts
– Chromatograms, spectra, photographs
– Recorded data from other automated instruments

• Importance of raw test data

– Integrity of test assured and verifiable
– Documented proof for conclusions drawn
– Traceability assured
– Regulatory requirement

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 Documentation
Log Books

• Bound workbooks or controlled worksheets

• Sequential numbering of pages
• Indexing if required
• Issue, use and archival controlled
• User traceable, acknowledge receipt
• Concurrent entries in log books / sheets
• Pages not detached, blank pages signed off
• Attachments easily identifiable and traceable

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 Documentation
Final Reports & COA

• Both customer and regulatory requirement

• Must include complete data of the item tested
• Must have protocol reference
• Must be dated
• Must refer to the specifications or specs included
• Initials or signature of the person who tested
• Initials or signature of a second person who verified the
original records
• Clear statement of sentencing

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 Documentation
Archival

• Must have a company policy of document retention, that

should meet minimum regulatory requirements
• Wherever possible original records to be retained
• Photographs, photocopies and microfilms acceptable
• Electronic data should have regular back-ups (robust
validation required)
• Secure storage, preferably flame proof areas
• Restricted and controlled access to archived records
• Destruction of old records as per schedules

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 Equipment Calibration

• All testing & measuring instruments influencing test results

must be calibrated
– Assures test correctness and dependence
– Ensures regulatory compliance
– Frequency to be risk based and justified
– Calibration procedures in place
– Acceptance criteria defined
– Reference standards traceable
– Each instrument uniquely identified
– Calibration status displayed
– Calibration done by trained operators
– All records maintained

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 Out of Specification Investigations

• What is OOS
– A result not meeting specified criteria

– Atypical is not an OOS, but need to be investigated

• OOS and atypical results could be due to

– Laboratory error

– Operator error (non-process related)

– Process related error (usually in mfg)

– Material related errors

– Environment related factors

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 Out of Specification Investigations

• Investigations
– Laboratory investigation by laboratory staff
– Expanded laboratory investigation lead by QA
– Outside laboratory investigations (production, warehouse, engineering
etc.)
– Any retesting, re-sampling must be justified
– Root cause need to be established
– Investigation details must be documented
– Corrective And Preventive Actions (CAPA) agreed
– Should be reviewed during batch releases

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 Internal Audit (Self Inspection)

• It is a management responsibility
– Must be a part of the Quality Plan
– SOP available and scope defined
– Schedules drawn up (typically at least quarterly)
– Team for audit identified and trained
– Cover all laboratory areas and systems
– Issue report as soon as possible
– Get CAPA commitments
– CAPA tracking system put in place
– Findings discussed in management review meetings

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 Good Housekeeping & Laboratory Safety

• Housekeeping and safety go hand in hand

• Work areas maintained clean and tidy

• Do not permit eating, drinking and smoking in laboratory

• Laboratory garment regime in place.

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 Good Housekeeping & Laboratory Safety

• Personnel Protective Equipment

• Safety glasses
• Gloves
• Nose masks
• Safety shoes and helmets (for samplers)
• First aid box, eye wash fountains
• Fire extinguishers, fire alarms
• Fire escape routes identified and displayed
• Waste disposal procedures
• Cut off arrangements for ovens and incubators

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 Good Housekeeping & Laboratory Safety

• Safety procedures must be known to all staff

• Provide awareness on laboratory safety
– Fire hazards (e.g.: use of naked flame, flammable solvents)
– Handling of corrosive chemicals (e.g.: Acids, Bromine)
– Explosive hazards (e.g.: Hydrogen gas cylinder)
– Poisons (e.g.: Potassium cyanide, lead salts, mercury)
– Pressure vessels (e.g.: autoclaves, pressure cooker)
– Electrical safety (e.g.: cable connections, switches)
– Cuts and wounds (e.g.: glassware)
– Biohazards (e.g.: cultures and media)
• Provide Laboratory Safety Manual to all staff

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 Productivity in Laboratory

• Timely customer support

• Better space utilization
• Simplified & logical workflow
• Rationalization of testing
• Automation
• Right first time results
• Simplified documents & document flow
• Elimination of non-value adding activities
• Improved visibility of lab operations

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 Benefits of Lab Productivity

• Capacity increase in laboratory

• Reduced cost of testing

• Regulatory compliance assured

• Product quality assured

• Improved morale of staff

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 Message

• Consumer satisfaction and regulatory compliance are two

parameters of paramount importance for any manufacturing
operations

• Laboratory is a place for key decision making. Without robust

laboratory controls, the business will suffer

• Laboratory efficiency is critical to business success like any

other functional efficiency.

• As a part of laboratory team, you need to focus on that

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 Any Questions

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