This presentation gives a summary of WHO guidance on Preparation of Laboratory Information File.

1. This presentation is compiled by “ Drug Regulations”
a non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.

2. This presentation is compiled from freely available resource
like the website of WHO specifically the
WHO Guidance titled
“Guidelines for preparing a laboratory information file
published in WHO TRS 961 , 2011”
“Drug Regulations” is a non profit organization which
provides free online resource to the Pharmaceutical
Professional.
Visit Our Website GMP Training
for latest information from the world of Pharmaceuticals.
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3.  The WHO Expert Committee on Specifications for Pharmaceutical
Preparations adopted in its thirty-eighth report in 2003 the
Guidelines for preparing a laboratory information file
◦ (WHO Technical Report Series, No. 917, 2003, Annex 5).
 The content of these guidelines is closely related to WHO guidelines
on good practices for pharmaceutical quality control laboratories,
 These were revised
◦ (the revised version was adopted by the WHO Expert Committee at its forty-
fourth meeting in 2009).
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4.  The WHO Expert Committee on Specifications for
Pharmaceutical Preparations discussed the need for a revision
of both sets of guidelines at its forty-third meeting in 2008
 It was recommended that if the Guidelines for good practices
for national pharmaceutical control laboratories were revised,
the Guidelines for preparing a laboratory information file
should be revised accordingly.
 On the basis of the above new guidance will replace the
previously published guidelines.
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5.  The revised guidelines addresses the following
1. General information on the laboratory
2. Quality management system
3. Control of documentation and records
4. Personnel
5. Premises
6. Equipment
7. Materials
8. Subcontracting of testing
9. Handling of samples
10. Validation of analytical procedures
11. Investigation of out-of-specification results
12. Stability testing (where applicable)
13. Microbiological testing (where applicable)
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6.  A laboratory information file (LIF) is a document prepared by
the laboratory.
 It contains specific and factual information about the
operations carried out at the named site
 It also covers any closely integrated operations of the
laboratory.
 If only some of the operations are carried out on the site, the
LIF needs to describe only those operations,
◦ e.g. sampling, chemical analysis or stability testing.
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7.  An LIF should be written in English, succinct and, if possible,
should not exceed 30 A4 pages, excluding appendices.
 The laboratory should give a short description of its activities
under each of the following headings. ( See background slide)
 Policy or essential steps for each activity should be described
 There should be a reference to a standard operating
procedure (SOP) or other supporting documents
 Where appropriate, supportive documentation should be
appended.
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8.  Give brief information on the laboratory
 This should include name, physical (location) and mailing
address, contact details and brief history.
 If the laboratory is part of an organization or company,
provide details of its position within the organization or
company, including reporting lines
◦ (e.g. organizational chart).
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9.  Provide a summary of all laboratory
activities.
 This should include
◦ Objectives of the laboratory
◦ Categories of customers
◦ Types of sample tested
◦ Relation (if any) to a manufacturing site
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10.  Mention areas of expertise proposed for prequalification
 Provide a list of methods and tests
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11.  Provide a brief description of a policy for
participation in
◦ Proficiency testing schemes
◦ Collaborative trials
 This is for the evaluation of the performance.
◦ Attach the list of tests in which the laboratory has
participated in the last three years, including the organizer
and results.
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12.  Provide a short description of the quality
management system implemented in the
laboratory,
 Give reference to the standard used
◦ WHO good practices for pharmaceutical quality control
laboratories
◦ ISO 1702
◦ Good Manufacturing Practices
◦ A quality manual.
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13.  Provide information on
◦ Inspections carried out by national or regional authorities
◦ External audits performed in the laboratory
◦ This should be for last three years,
◦ Give reference to valid accreditation, certificate,
authorization or licence.
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14.  Provide brief description of the procedures for
 Internal audits
 Implementation of corrective and preventive
actions
 Complaints.
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15.  Provide brief description of the procedures for the
control of and changes to documents that form a part
of the quality documentation.
 Attach a list of valid SOPs.
 Provide brief description of the procedures for the
preparation, revision and distribution of necessary
◦ Documentation for specifications
◦ Standard test procedures
◦ Analyst workbooks or worksheets.
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16.  Provide brief description of any other documentation
related to
◦ Product testing
◦ Reports
◦ Records,
◦ Arrangements for the handling of results
◦ Laboratory information management systems (LIMS), where
used
 Provide brief description of the procedures for release
of certificates and analytical reports.
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17.  Provide
◦ Number of employees engaged in the following activities:
 ( See Next slide)
◦ An organization chart showing the arrangements,
responsibilities and reporting lines in the laboratory.
◦ Qualifications, experience and responsibilities of key
personnel.
◦ An Outline of arrangements for initial and ongoing training
and its recording.
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18.  Provide
◦ Number of employees engaged in the following activities:
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19.  Provide /give details of
◦ Simple plan or description of the layout of the laboratory areas
◦ Indication of scale
 (architectural or engineering drawings not required, but
photographs may be submitted if available).
◦ Nature of construction and finishing.
◦ Ventilation systems
 Systems for microbiological testing areas, storage areas, etc.
◦ Reference to air circulation and control of temperature and
relative humidity.
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20.  Provide /give details of
◦ Special areas for the handling and storage of hazardous
materials such as
 Highly toxic (including genotoxic),
 Poisonous and flammable materials.
◦ Planned programmes for preventive maintenance of the
premises and the system for recording maintenance activities.
◦ Procedures for cleaning of areas and equipment.
◦ Storage areas (size, location) including arrangements for the
storage of materials and retention samples.
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21.  Provide brief description /give details of
◦ Main equipment used in the laboratory.
 Attach a list of equipment in use, in tabular form, indicating the
equipment and its brand model and date of installation.
◦ Planned programme for the preventive maintenance of
equipment and the system for recording the maintenance
activities.
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22.  Provide brief description /give details of
◦ Arrangements and status for qualification of equipment
 Installation qualification (IQ),
 Operational qualification (OQ) and
 Performance qualification (PQ))
◦ Calibration of measuring equipment, including the recording
system.
◦ Computer system and its validation and data integrity
management, including access to data and frequency of back-
up.
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23.  Provide brief description /give details of
◦ General policy for purchasing and handling of materials
 including chemicals and reagents and availability of safety data sheets)
◦ Handling of waste.
◦ Procedure for selection and evaluation of suppliers.
◦ Water system in the laboratory, its qualification and
arrangements for the sampling and testing of the water.
◦ System for purchasing, preparation, handling and storage of
reference substances and reference materials.
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24.  Provide brief description /give details of
◦ Subcontracting of testing
◦ Activities contracted out to other laboratories
◦ Names and addresses of subcontractors of
subcontractors.
◦ How compliance with standards for activities
contracted out is assessed.
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25.  Provide brief description /give details of
◦ Handling of samples
◦ General policy for sampling.
◦ Procedures used and standards applied. ( If laboratory
is responsible for sampling)
◦ Procedures for handling of samples from their receipt
to storage after completion of testing.
◦ Flow charts of important steps and work allocation in
the laboratory .
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26.  Provide brief description /give details of
◦ Validation of analytical procedures
◦ General policy for validation of analytical
methods,
◦ General policy of verification of pharmacopoeial
methods
◦ General policy for verification/ validation or
analytical procedures validated by manufacturers
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27.  Provide brief description /give details of
◦ Investigation of out-of-specification results
◦ Procedure for recording and investigation of out-
of-specification results.
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28.  Provide brief description /give details of
◦ Stability testing (where applicable)
◦ Stability testing procedure.
◦ Conditions under which samples are kept,
◦ Arrangements for monitoring and the equipment
used.
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29.  Provide brief description /give details of
◦ Microbiological testing (where applicable)
◦ Activities for microbiological testing.
◦ Preparation and control of media and types of media
used.
◦ Procedure in place for positive and negative controls.
◦ Validation policy.
◦ Arrangements for waste disposal.
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30. This presentation is compiled from freely available resource
like the website of WHO specifically the
WHO Guidance titled
“Guidelines for preparing a laboratory information file
published in WHO TRS 961 , 2011”
“Drug Regulations” is a non profit organization which
provides free online resource to the Pharmaceutical
Professional.
Visit Our Website GMP Training
for latest information from the world of Pharmaceuticals.
01-09-2016 30
Visit Our WEBSITE GMP Training
http://fdagmp.blogspot.in/