General provisions,Organisation ,Personnel and Facilities

1. GLP
General Provisions
Organization
Personnel & Facilities
SURBHI SHARMA
17BPH097(BATCH-E)

2. INTRODUCTION
 Good Laboratory Practice(GLP) regulations became part of
regulatory landscape in the latter part of the 1970s in response
to malpractice in R&D activities by pharmaceutical companies.

3.  GLP is a quality system concerned with the organizational
process and the conditions under which non-clinical health and
environmental safety studies are planned , performed ,
monitored , recorded , achieved and reported
 In 1981,the Organization for Economic Cooperation and
Development(OECD) also published GLP Principles.
 To date 30 countries have signed an agreement binding them to
OECD GLP Principles.
 The intent of the GLP is to regulate the practices of scientists
working on the safety testing of prospective drugs.

5. OBJECTIVES
 The GLP regulations set out the rules for good practice and help researchers perform their work in
compliance with their own pre-established plans and standardized procedures.
 All GLP texts, irrespective of their origin, stress the importance on following 5 points:
1. Resources: Organization , personnel , facilities and equipment.
2. Characterization: Test items and test systems.
3. Rules: Study plans and written procedures.
4. Results: Raw data, final report and archives.
5. Quality Assurance
 The training programme of the WHO covers each of these five fundamental points and explains
the requirements of GLP in each case.

6. QUALITY ASSURANCE PROGRAMME
 General Provisions:
 The test facility should have a documented Quality
Assurance Programme to assure that studies
performed are in compliance with these Principles of
Good Laboratory Practice.
 The Quality Assurance Programme should be carried
out by an individual or by individuals designated by
and directly responsible to management and who are
familiar with the test procedures.
 This individual(s) should not be involved in the
conduct of the study being assured.

7. TEST FACILITY ORGANISATION
 Each test facility management should ensure that these Principles of Good
Laboratory Practice are complied with , in its test facility.
 It should ensure that a sufficient number of qualified personnel, appropriate
facility, equipments and materials are available for the timely and proper conduct
of the study.
 It should ensure that a statement exists which identifies individual(s) within a test
facility who fulfill the responsibilities of management as defined by these
principles of Good Laboratory Practices.
 Ensure the maintenance of the master schedule.
 Establish procedures to ensure that computerized systems are suitable for their
intended purpose , and are validated , operated and maintained in accordance
with these principles.

8.  Principal Investigator’s Responsibility:
 She/he will ensure that the delegated phases of study are conducted in accordance
with the applicable principles of GLP.
 Study Director’s Responsibility:
 Has study control and responsibility for the overall control of the study and for its
final report.
 Ensure that all raw data generated is fully secured and documented.
 Ensure that the computerized systems used in study have been validated.
 Study Personnel Responsibilities:
 All personnel responsible for the conduct of study must be knowledgeable.
 They are responsible for recording raw data promptly.

9. PERSONNEL
 GLP requires that the overall organization of the
test facility be defined.
 This is usually done through an organization
chart.
 This is often the first document requested by
inspectors to obtain an idea of how the facility
functions.
 Sometimes the organization chart forms part of a
quality manual or other document that describes
the nature of the institution and the way in which
it operates.

10.  These are high level documents. They are
supplemented by more detailed
information which may be incorporated
into following documents relating to each
individual:
1. Curriculum vitae
2. Training records
3. Job description
 Together these three documents meet
the GLP requirement.

11.  In a CV , it is usual to include:
 Name and age of the person,
 Education including diplomas qualifications awarded
by recognized institutions,

12.  Languages spoken,
 Membership of associations,
 Any publications,
 Professional experience earned both within the
institution and before joining it.
All staff should have a CV.It is a good practice to have
the CV signed and dated by the person concerned.

13. CURRICULUM VITAE(CV)
A procedure should ensure that the CV’s:
 Exist for all personnel in a standard
approval format.
 Are kept up-to-date.
 Exist in required languages(local and
sometimes English for local submission)
 Are carefully achieved to ensure
historical reconstruction

14. TRAINING RECORDS
 Training complements CV.
 Job competence depends largely on internal and external
specialized training.
 GLP requires that all personnel should understand the meaning
of GLP , its importance , and the position of their own tasks
within GLP activities.
 Training must be formally planned and documented.
 New objectives and activities always involve some training.
 Training systems are usually SOP based.
 The training system will have elements common to all GLP
management systems i.e.it is formal , approved , documented
to a standard format , described in a SOP.

15. JOB DESCRIPTION
 All systems of quality management are based
on making people responsible for their actions.
 Having job descriptions with clear definition of
tasks and responsibilities is essential for
everyone.
 The contents of job description should
correspond to the qualifications described in CV.
 Annual reviews of job descriptions help
management ensure that their organization is
coherent.

16.  Responsibilities of QA Personnel:
 They should maintain the copies of all approved
study plans and Standard Operating Procedures in
use in the test facility and have access to an up-to-
date copy of the master schedule.
 All personnel involved in the conduct of the study
must be knowledgeable in those parts of the
Principles of Good Laboratory Practice which are
applicable to their involvement in the study.
 It is their responsibility to comply with the
instructions given in these documents.
 Any deviation from these instructions should be
documented and communicated directly to the Study
Director, and/or if appropriate, the Principal
Investigators.

17.  All study personnel are responsible for recording raw
data promptly and accurately and in compliance with
these Principles of Good Laboratory Practice, and are
responsible for the quality of their data.
 Study personnel should exercise health precautions
to minimize risk to themselves and to ensure the
integrity of the study.
 They should communicate to the appropriate person
any relevant known health or medical condition in
order that they can be excluded from operations that
may affect the study.
 Verify that the study plan contains the information
required for the compliance with these Principles of
Good Laboratory Practice. This verification should be
documented.

18.  Conduct inspections to determine if all studies are
conducted in accordance with these Principles of Good
Laboratory Practice.
 Inspections should also determine that study plans and
SOPs have been made available to study personnel and
are being followed.
 Inspections can be of three types as specified by QA
Programme SOPs:
o Study-based
o Facility-based
o Process-based
 Inspect the final reports to confirm that the methods ,
procedures , and observations are accurately and
completely described , and that the reported results
accurately and completely reflect the raw data of studies.

19. FACILITIES
General:
 The test facility should be of suitable size,
construction and location to meet the
requirements of the study and to minimize
disturbance that would interfere with the
validity of the study.
 The design of the test facility should provide
an adequate degree of separation of the
different activities to assure the proper
conduct of each study.

20. TEST SYSTEM FACILITIES
 The test facility should have a sufficient number of rooms or
areas to assure the isolation of test systems and the isolation of
individual projects , involving substances or organisms known to
be or suspected of being bio-hazardous.
 Suitable rooms and areas should be available for the diagnosis ,
treatment and control of diseases in order to ensure that there is
no unacceptable degree of deterioration of test systems.
 There should be storage rooms or areas as needed for supplies
and equipment.
 Storage rooms or areas should be separated from rooms or areas
housing the test systems and should provide adequate
protection against infestation , contamination or deterioration.

21.  BUILDINGS:
 GLP required that the test facilities be of appropriate
size , construction and location to meet the
requirements of study and minimize disturbances
that would interfere with the validity of study.
 They should be designed to provide an adequate
degree of separation between the various activities
of the study.
 The purpose of these requirements is to ensure that
the study is not compromised.
 Minimizing disturbances by separation can be
achieved by :
o Physical Separation.
o Separation by organization.

22. o Physical Separation: This can be achieved
by walls, doors or filters or by the use of
isolators. In new buildings or those under
transition and renovation , separation
will be part of design.
o Separation by Organization: By the
establishment of defined work areas
within a laboratory carrying out different
activities in the same area at different
times.

23. o Size:
 The laboratory must be big
enough to accommodate the
staff working in it and allow
them to carry their own work
without risk of interfering in
each other’s work.
 Each operator should have a
separate working station
sufficiently large to be able to
carry out operation efficiently.
 There should be physical
separation to avoid mixing up
of materials.
 The dose mixing area is
sensitive zone and access to it
should be restricted.

24. o Construction:
 The laboratory should be built of materials that allow
easy cleaning and prevent cross-contamination.
 There should be proper ventilation system with filters.
o Arrangement:
 There should be separate areas for:
 Storage of control and test items.
 Storage of vehicles.
 Handling of volatile materials.
 Weighing operations.
 Storage of prepared doses.
 Changing room.
 Cleaning equipment.
 Office and refreshment rooms.

25. o Animal House Facility:
 To minimize the effects of environmental variables
on the animal , the facility should be designed and
operated to control selected parameters.
 This facility is provided to prevent animals from
coming in contact with the diseases.
 The buildings and room should provide sufficient
space for animals and studies , allowing the
operators to work efficiently.
 Design should allow easy and thorough cleaning of
the surfaces of walls , doors , floors and ceilings.
 There should be no gaps or ledges where the dirt
may accumulate.

26.  A typical Animal house should have separations maintained by provision of
areas for:
 Different species
 Different studies
 Quarantine
 Changing rooms
 Receipt of materials
 Storage of materials
 Necropsy
 Waste Disposal

27. Facilities for Handling Test and
Reference Items
 To prevent contamination or mix-ups , there
should be separate rooms and areas for receipt
and storage of the test ad reference items , and
mixing of the test items with a vehicle.
 Storage rooms or areas for the test items should
be separate from rooms or areas containing the
test systems.
 They should be adequate to preserve identity ,
concentration , purity and stability and ensure
safe storage for hazardous substances.

28.  Apparatus , including validated computerized systems
, used for the generation , storage and retrieval of
data , and for controlling environmental factors
relevant to the study should be suitably located and
of appropriate design and adequate capacity.
 Apparatus used in the study should be periodically
inspected , cleaned , maintained and calibrated
according to SOPs. Records of these activities should
be maintained. Calibration should , where
appropriate , be traceable to national or international
standards of measurement.
 Apparatus and materials used in a study should not
interfere adversely with the test systems.

29.  Archive Facilities:
 Archive facilities should be provided for the secure
storage and retrieval of the study plans , raw data ,
final reports , samples of test items and specimens,
 Archive design and archive conditions should protect
contents from untimely deterioration.
 Waste Disposal:
 Handling and disposal of wastes should be carried
out in such a way as not to jeopardise the integrity
of studies.
 This includes provision for appropriate collection ,
storage and disposal facilities , and decontamination
and transportation procedures.