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 Good Laboratory Practice

(GLP) - an Overview
 Overview
 Overview
 The GLP have been in existence for
non clinical safety studies since 1976.
 They have been progressed through
various transitional phases to become
guidelines in some countries and
regulatory/statutory instruments in
others.
 Overview
 The current document is the
Organization for Economic Co-
operation and Development (OECD)
Principles of GLP and is currently
accepted as the industry standard.

 This was published in January 1997

 Overview
 Guidelines of other countries, i.e
USFDA, USEPA (Environmental
Protective Agency) are similar rules to
OECD principles.
 If data generated to the OECD
principles, will be accepted in US &
Japan.
Objective of the Guideline
 Objective of the Guidelines
 In early 1970’s one company
(Industrial Biotest) was found to be
generating extremely poor quality
data, in a fraudulent manner.
 This, therefore caused the FDA to
put together and implement the
GLPs.
 Objective of the Guidelines
 Over the next 10 years many countries
introduced similar good-practices
guidelines.
 The EU produced a standard document
by the OECD in the early 1980s and
became industry standard.
Objective of the Guidelines
 Benefit of OECD:

Data generated by one company to

be accepted by several receiving
authorities without further
inspection.
 Objective of the Guidelines
 It must be remembered that GLP is
merely commonsense in a formal
environment.
 GLP environment include good
documentation, training, maintenance
and calibration of all equipment, the
archiving and storing of data in a formal
and retrievable manner.
Who does it affect ?
 Who does it affect?
 Any company or institution performing
nonclinical safety studies for the
submission of data for a new chemical
entity.
 Within a company, every person from
Sr.Management to Jr.Technician
bound by these GLPs.
Why have it ?
 Why have it?
 In general terms,
For companies conducting nonclinical safety
studies, it is, a regulatory requirement,
and without this compliance certificate,
data will generally not be accepted by the
regulatory/receiving authorities
 Why have it ?

 Over the past 5 years, many companies

have gone far beyond the requirements
of GLP compliance
 Why have it?
 But many laboratories, for example,
where the refrigerator has been
located far from its permitted limits.
Where the temperature recorded,
signed and dated as required by GLP,
but where neither document the
excursions outside the accepted range
nor to rectify the problem.
Why have it?
 This is GLP despite the damage
that excursions outside the
temperature range may have
caused to any investigational
product stored in the refrigerator.
How it Enforced ?
 How is it Enforced?
 All countries have a regulatory group,
also acts as the receiving authority for
the review of data, and reports to the
GLP Monitoring Authority.
 This regulatory group visits on a 2 year
basis or in Germany 4 year basis.
How is it Enforced?
 The inspection may be performed
by 1 or 2 persons for 1 to 5 days.
 At the end of day, an exit meeting
is held, Non compliance points are
noted in writing and discussed and
a report is then prepared.
What is GLP ?
 What is GLP?
 The OECD covers a series of activities
and personnel.
 Responsibilities,
 Training,
 Quality Assurance,
 Standard Operating Procedures(SOPs)
 Study plan and study reports,
What is GLP?
 Data production and recording,
 Equipment maintenance and
calibration,
 Computers and validation,
 Test systems and test substances
 Archiving areas
covered by the GLPs.
What is GLP?
 Responsibilities:
 The prime players in a GLP scenario
would be –
a. Management
b. The Sponsor
c. The Study Director
d. The Principle Investigator
e. Quality Assurance.
 What is GLP?
 Management: would be totally
responsible for the conduct of the work.
 The Sponsor: is the person who is
supplying the money and the request for
the work.
 Study Director: is the prime player and is
ultimately responsible for the production
of the study plan.
 What is GLP?
 Principal Investigator: is the next line of
responsibility after the Study Director in
a multisite study.
 QA: This will involved in conduct the
study, but merely reviews the data,
experimental work, ensure the
documents compliance to SOPs, the
study plan, and GLP.
 What is GLP?
 Other activities of QA:

Training and assistance in interpreting

GLPs.
 What is GLP?
 SOPs
 These generally have been likened to a
complete documented history of the
entire aspect of conducting nonsafety
studies.
 Once produced SOPs must be reviewed
on a regulator basis (every 2Years).
 What is GLP?
 SOPs:
 Any changes these procedures must be
made in writing.
 The SOP itself must be filed in the
archive, additional copies produced.
 SOPs must be appear in the adjacent of
workplace to all persons.
 SOPs can be paper-based or electronic.
What is GLP?
 Study Plan and Reports:
 The study plan is merely an
indication of all of the activities that
will take place, resources required,
time frames and objectives.
 Both the study plan and report are
audited by QA.
 What is GLP?
 Data:
 Raw data is generally considered the
first records made, either
electronically or paper-based.
 In regards to the data they should be
recorded promptly, legibly and signed
and dated.
 What is GLP?
 Equipment:
 GLP requires that equipment be maintained,
calibrated, and generally demonstrated as
fit for use.
 Equipment should have a log book that
gives a historical record of its use.
 The calibration and validation should be
stated as “fit for use”.
 What is GLP?
 Computers:
 Inspectorate is to ensure that they are
fully validated.
 Validation could be covered by “evidence
that the computer will perform the task
for which it was purchased and more
importantly, continue to perform that
task for the foreseeable future.
 What is GLP?
 Computers:
 If in house software programs are
produced, are tested and validated
and the source code is made
available.
 Important rule is that the
“electronic signatures rule”.
 What is GLP?
 Archives :
 Having addressed all the various aspects
of the study, one can see that much
documentation, tissues, slides and wax
blocks could well be accumulating.
 The requirement is to store this material
for a “period of time”.
How can compliance be
maintained within a Facility?
 How can compliance be
maintained within a Facility?
 Compliance, having been granted after
an inspection, should be monitored on
a daily basis.
 Training and retraining along with an
awareness of the requirement to
comply with GLP, are immense
important.
 How can compliance be
maintained within a Facility?
 A good point to review internally and
on a regular basis:
1. Problems that have been encountered in
experimentation.
2. Audit findings.
3. Ways to improve work by looking at new
systems and reviewing SOPs to ensure that
these are current.
4. Areas where improvements can be made.
Pitfalls and Benefits
 Pitfalls and Benefits
 An independent body should look at
why problems occur and at the sorts of
problems that occur and carrying out
regular reviews with Sr. management
about these problems.
 Costs will increase because of time
pressure and the necessity of involving
third party reviews.
Pitfalls and Benefits
 Time must be taken to write and
review SOPs. This in itself very
costly exercise.
 One company, having spent more
than 6 months to write SOPs and
put a value $5500 on that volume.
 Pitfalls and Benefits
 All nonclinical safety studies, when
conducted according to the principles
of GLP and adequately addressing
science as well as compliance,
 can achieve high success rate both in
the outcome of the science and in the
acceptance of data for a regulatory
submission.
Thanks