1. BY- ANUBHAV SINGH
M.PHARM 1st
Year
IPR, GLA UNIVERSITY

2. It is a standard for clinical studies or trials that encompasses
the design, conduct, monitoring, termination, audit, analyses,
reporting and documentation of the studies.
It ensures that the studies are implemented and reported in
such a manner that there is public assurance that the data are
credible, accurate and that the rights, integrity and
confidentiality of the subjects are protected.
GCP aims to ensure that the studies are scientifically
authentic and that the clinical properties of the
“Investigational Product” are properly documented.

3. *To understand:
*The affect of Good Clinical Practices on institutions conducting
Clinical Research
*To discuss:
*What is GCP
*Guidelines for GCP
*The history of Good Clinical Practices
*Basic principles
*Practices and strategy for staying compliant with Good Clinical
Practices.

4. *GCP`s are mainly focused on the protection of human rights in
clinical trial.
*Provide assurance of the safety of the newly developed compounds.
*Provide standards on how clinical trials should be conducted.
* Define the roles and responsibilities of clinical sponsors, clinical
research investigators, Clinical Research Associates, and monitors.
*GCPs are generally accepted, international best practices for
conducting clinical trials and device studies.
*They are defined as an international ethical and scientific standard
for designing, conducting, recording and reporting trials that
involve the participation of human subjects.
*Compliance with GCPs provide public assurance that the rights and
safety of participants in human subject research are protected and
that the data that arises from the study is credible

5. GCPs are generally accepted, international best practices
for conducting clinical trials and device studies.
They are defined as an international ethical and scientific
standard for designing, conducting, recording and reporting
trials that involve the participation of human subjects.
Compliance with GCPs provide public assurance that the
rights and safety of participants in human subject research
are protected and that the data that arises from the study is
credible

6. Good Clinical Laboratory Practices should be used by all laboratories
where tests are done on biological specimens for diagnosis, patient
care, disease control and research such as:
• Microbiology & Serology
• Hematology & Blood Banking
• Molecular Biology and Molecular Pathology
• Clinical Pathology
• Clinical Biochemistry
• Immunology (Immunohematology and Immuno biochemistry)
• Histopathology/Pathology and Cytology

8. Infrastructure of laboratories should be planned according to the services provided
by
the laboratory. The basic infrastructure facilities include:
• Reception room/area where requisition forms are received and reports
disbursed.
• Specimen collection room/area, toilets, privacy for special purposes e.g. semen
collection, facilities for disabled persons, toilet for staff.
• Quality water supply for analytical purpose.
• Uninterrupted power supply.
• Analytical work area.
• Specimen/Sample/slide storage facility including cold storage where applicable.
• Record room/area.
• Facility for cleaning of glassware, sterilization /disinfection.
About Laboratories

9. • Waste disposal facility including biomedical wastes
• Fire-safety equipment
• Ventilation, climate control and lighting arrangements
• Separate room/area for meetings/administrative work
• Separate facilities/area for staff for hand washing, eating
and storing food,
drinks etc.
• Communication facility with referral centers
• Transport of specimen/samples to referral centers
• Additional infrastructure facilities may be added for special
tasks as and when
needed.
Co nt.

10. The laboratory should maintain a personal file of all the technical and
nontechnical staff employed. Personal file should contain all information
on:
•Personal bio-data including educational qualification and experience
•Copy of degree/diploma and registration with state authority if
applicable
•Copy of appointment letter
•Duly verified health information (physical fitness including color
blindness, immunizations received etc.) prepared at the time of
employment and its regular updates
•Performance appraisal
•Training certificates, awards/recognition received
•Disciplinary action if any taken by the management
•Reference letter from previous employer if applicable
About Personnel's

11. • Each laboratory should prepare an exhaustive list of equipment
and consumables required and available for general functioning
of the laboratory and specialized equipment for special tests.
• Equipment should be suitably located in the laboratory so as to
allow accessibility and sequential utilization thus minimizing
the need for frequent movement of specimens or reagents.
• All equipment should be in good working condition at all times.
Periodic inspection, cleaning, maintenance of equipment should
be done. An equipment log book should be maintained for all
major equipment. Laboratories should maintain necessary
instructions for operation and maintenance of equipment in the
form of Standard Operating Procedures (SOPs). A copy of SOP
should be readily available.
About Equipment's

12. • Standard reagents of certified quality must be used for the
purpose of analysis.
• The batch number of reagents must be recorded. The quality of
the reagent viz. Annular grade, HPLC grade, etc. to be used for
in-house procedures should be defined in SOP
• The reagents, chemicals and consumables should be stored
under appropriate environmental conditions.
• Quality of newly purchased reagents should be validated
against suitable control/reference material prior to use.
Validation data should be properly documented. In-house
prepared reagents should also be checked periodically for
stability and a record of the same should be maintained.
About Reagents and Materials

13. • Laboratory data management includes recording details of the
patient, findings of analysis, reporting of results and archiving
the data for future reference.
• Recording data allows smooth functioning of the internal
quality control measures, internal audit and external quality
assessment. From the point of view of management, absence
of record implies that the work was never done.
• The format of recording and reporting results should be
described in the Standard Operating Procedures (SOPs).
• Data entry should begin as soon as registration number is
assigned to the specimen. Further entries should be made in
the accession list and worksheet.
• The final report should be recorded after approval/signature
of the designated authority.
Data Management

14. • SOP is a document, which contains detailed, written instructions
describing the stepwise process and technique of performing a test or
procedure in the laboratory.
• SOP helps to ensure uniformity, consistency and control over the
processes carried out. It ensures that the procedures are done in
exactly the same way each time irrespective of the operator.
• SOP should contain information on who can perform the test, their
qualification and training, how to carry out the test including pre-
analytical, analytical and post-analytical stages of test/procedure,
laboratory conditions required for the test/ procedure, routine care
and maintenance of equipment, precautions and safety instructions,
trouble shooting measures, waste disposal and linkage with reference
laboratories.
• SOP should be simple and written in an easy to understand language.
• The procedure described in the SOP must be followed exactly by all
staff members to ensure high quality results.
Standard Operating Procedures (SOP)

15. Where, GQP- Good Quality Practices
GVP- Good Vigilance Practices
PV- Pharmacovigilance
GD- Guidance Documents

17. 1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the
Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements.
2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated
benefit for the individual trial subject and society. A trial should be initiated and continued only if the
anticipated benefits justify the risks.
3 The rights, safety, and well-being of the trial subjects are the most important considerations and should
prevail over interests of science and society.
4 The available non clinical and clinical information on an investigational product should be adequate to
support the proposed clinical trial.
5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
6 A trial should be conducted in compliance with the protocol that has received prior institutional review
board
(IRB)/independent ethics committee (IEC) approval/favorable opinion.
7 The medical care given to, and medical decisions made on behalf of, subjects should always be the
responsibility of a qualified physician or, when appropriate, of a qualified dentist.

18. 8 Each individual involved in conducting a trial should be qualified by education, training, and experience to
perform his or her respective tasks.
9 Freely given informed consent should be obtained from every subject prior to clinical trial participation.
10 All clinical trial information should be recorded, handled, and stored in a way that allows its accurate
reporting, interpretation, and verification
11 The confidentiality of records that could identify subjects should be protected, respecting the privacy and
confidentiality rules in accordance with the applicable regulatory requirements.
12 Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP). They should be used in accordance with the
approved protocol.
13 Systems with procedures that assure the quality of every aspect of the trial should be implemented.
Co nt.

19. *Prior to an actual set of guidelines to follow for good clinical
practice, clinical studies were dangerous and could result in
serous disease, or possibly death
*The Nuremburg Code of 1947
* Experiments performed in Germany during WWII opened the eyes of the world
for guidance for clinical testing on humans.
* The code did set ethical guidelines, but it lacked legislation to back it up.
*Declaration of Helsinki
*In 1964, the World Medical Association established recommendations
guiding medical doctors in biomedical research involving human
subjects. These guidelines influenced national legislation, but there
was no set standard between nations

20. The Good Clinical Practice Program is the focal point within
FDA regarding issues in human research trials regulated by FDA.
The Good Clinical Practice Program:
Coordinates FDA policies.
Contributes to leadership and direction through participation in
FDA's Human Subject Protection/Bioresearch Monitoring Council.
Coordinates FDA's Bioresearch Monitoring program with respect
to clinical trials, working together with FDA's Office of Regulatory
Affairs (ORA).
Contributes to international Good Clinical Practice harmonization
activities.
Plans and conducts training and outreach programs.

21. *The trials are conducted in 4 phases.
*Phase 1 trials are for determining dosing, document how a drug is
metabolized and identify side effects.
*Phase 2 trials gather further safety data and evidence of the drug's efficacy.
*Phase 3 trials further tests the product's effectiveness on a greater number
of participants, and monitors side effects.
*Phase 4 trials can be conducted after a product is already approved and on
the market to find out more about the treatment's long-term risks
*It is estimated that only 5 in 5,000 compounds that enter preclinical testing
make it to human testing, and only 1 of those 5 may be safe and effective
enough to reach pharmacy shelves.