Good Laboratory Practice Regulations
Frequent speaker and chair person at FDA, ISPE, PDA, USP. IVT,
and GAMP conferences and workshops
||Ludwig Huber and
Paul Lepore, FDA's 'Father of GLP' during a
GLP Workshop in Tokyo.
Paul Lepore told the audience how they should prepare for a
GLP inspection and what inspectors will ask.
Ludwig Huber explained how to implement computer validation
in GLP environment.
For Dr. Huber's connection with the FDA,
New OECD Guide: Using Computer Systems in GLP Studies
Understanding and Implementing the new OECD Guide for Computer
Recorded, available at any time
Introduction and Objectives and Key
Good Laboratory Practice (GLP) deals with the organization, process and
conditions under which laboratory studies are planned, performed, monitored,
recorded and reported. GLP practices are intended to promote the quality and
validity of test data.
Published GLP regulations and guidelines have a significant impact on the
daily operation of an analytical laboratory.
GLP is a regulation. It is not only good analytical practice.
Good analytical practice is important, but it is not enough. For
example, the laboratory must have a specific organizational
structure and procedures to perform and document laboratory work.
The objective is not only quality of data but also traceability and
integrity of data. But the
biggest difference between GLP and Non-GLP work is the type and
amount of documentation.
For a GLP inspector it should be possible to look at the
documentation and to easily find out
- who has done a study,
- how the experiment was
- which procedures have
been used, and
- whether there has been
any problem and if so
- how it has been
And this should not only be possible during and right after the
study has been finished but also 5 to 10 or more years later.
Frequently the question
comes: how much does this cost? It has been estimated that these
additional organizational and documentation requirements increase
operational costs of up to 30% compared to non-GLP operation.
The key requirements of a GLP type works are
should be defined for the sponsor management, for study
management and for the quality assurance unit.
- All routine work
should follow written standard operating procedures.
- Facilities such as
laboratories should be large enough and have the right
construction to ensure the integrity of a study, for example, to
avoid cross contamination.
- Test and control
articles should have the right quality and instruments should be
calibrated and well maintained
- People should be
trained or otherwise qualified for the job
- Raw data and other
data should be acquired, processed and archived to ensure
integrity of data.
Unfortunately most laboratories are in situations where they have
had to interpret the regulations. Procedures have been developed on
an ad hoc basis, in isolation, in response to inspections by both
their company’s Quality Assurance Unit and regulatory bodies.
Under such duress, many scientists in industry have developed
procedures to validate their instrumentation even though the same
approach will already have been applied at the instrument
manufacturer’s site. Standard operating procedures written to
accompany such validation efforts often duplicate extracts from
operation manuals —why don’t the manufacturers provide the SOPs
directly? When it comes to validating the instrument’s application
software, the person responsible has to take the manufacturer’s word
for it that the software has been validated and hope that supporting
documents, such as test results and source code are available to
regulatory agencies upon request.
This tutorial should help to understand requirements and with the
help of SOPs and examples offered by Labcompliance, to implement
requirement in a most cost effective way.
Various national legislation, e.g., the Federal Food, Drug, and
Cosmetic Act in the United States places the responsibility for
establishing the safety and efficacy of human and veterinary drugs
(and devices) and the safety of food and color additives on the
sponsor (manufacturer) of the regulated product. Public agencies
(the United States government’s Food and Drug Administration, FDA,
for example) are responsible for reviewing the sponsor’s test
results and whether or not they can demonstrate the product’s safety
and efficacy. Only when the agencies are satisfied that safety and
efficacy have been established adequately is the marketing of the
Fraud and misinterpreted data
Until the mid-1970s, the underlying assumption at the FDA was
that the reports submitted by the sponsors to the agency accurately
described study conduct and precisely reported the study data. A
suspicion that this assumption was mistaken was raised during review
of studies submitted by a major pharmaceutical manufacturer in
support of new drug applications for two important therapeutic
products. Data inconsistencies and evidence of unacceptable
laboratory practices came to light. The FDA requested a "for cause"
inspection of the manufacturer’s laboratories to determine the cause
and the extent of the discrepancies (a "for cause" inspection is one
initiated at the request of an agency when there are grounds for
doubt surrounding an FDA regulated product), and revealed defects in
design, conduct, and reporting of the studies. Further inspections
at several other sites found similar problems.
The conclusion that many of the studies on which proof of safety
of regulated products had been based could indeed be invalid alarmed
the FDA, the United States Congress, the public, and industry. Task
forces were soon formed to develop ways and means of ensuring the
validity and reliability of all non-clinical safety studies
submitted for FDA decision making. They would eventually publish
standards for measuring the performance of research laboratories and
define an enforcement policy.
Good Laboratory Practice (GLP) regulations were finally proposed on
November 19, 1976 for assuring a study’s validity. The proposed
regulations were designated as a new part, 3.e., of Chapter 21 of
the Code of Federal Regulations. The final regulations were codified
as Part 58 (21CFR).
The United States Environmental Protection Agency (EPA) issued
almost identical regulations in 1983 to cover the required health
and safety testing of agricultural and industrial chemicals under
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)4 and
the Toxic Substances Control Act (TSCA),5 respectively. The GLPs
were promulgated in response to problems encountered with the
reliability of submitted studies. Some of the studies were so poorly
conducted that "the resulting data could not be relied upon for the
EPA’s regulatory decision making process." 6 The EPA regulations
were extensively amended in 1989 and now cover essentially all
testing required to be submitted to EPA under either Act.7, 8 Both
GLP regulations are of a similar format and have, with few
exceptions, the same wording.
Even though GLPs were only issued for these two specific official
programs, the possession of sound data is an equally important
consideration for Agency decision makers in all EPA programs to
protect public health and the environment. We can thus expect the
GLP regulations to be more widely adopted — the Office of Solid
Waste has included GLP terms in its contracts for reproductive
For example, GLP regulations have been transferred under the
umbrella of the OECD as principles of Good Laboratory practices to
other countries like Europe and Asia
Relation to other Regulations
GLP vs. GCP, GMP and Part 11
Figure 1 illustrates how so called Good Practices regulations
correlate to the life of a drug, starting from
basic research and drug discovery on the left side through
preclinical development in the middle and clinical trials and
manufacturing at the right
Figure 1. GLP vs. GCP, GMP and 21 CFFR
Typically research and drug
discovery are not regulated at all. GLP starts with preclinical
development, for example toxicology studies. Clinical trials are
regulated by good clinical practice regulations and manufacturing
through GMPs. There is a frequent misunderstanding that all
laboratory operations are regulated by GLP. This is not true. For
example, Quality Control laboratories in manufacturing are regulated
by GMPs and not by GLPs. Also Good laboratory Practice regulations
are frequently mixed up with good analytical practice. Applying good
analytical practices is important but not sufficient, as we will see
in this presentation.
When small quantities of active
ingredients are prepared in a research or development laboratory for
use in samples for clinical trials or finished drugs, that activity
has be covered by GMP and not by GLP.
Part 11 is FDA’s regulation on electronic records and signatures
and applies for electronic records or to computer systems in all FDA
regulated areas. For example, it applies for computers that are used
in GLP studies.
Characteristic for GLPs is that they are study based where as
GMPs are processed based.
Independent from Location and Duration of a Study
GLPs regulate all non-clinical safety studies that support or are
intended to support applications for research or marketing permits
for products regulated by the FDA,
or by similar other national agencies. This includes drugs
for human and animal use but also aroma and color additives in food,
biological products and medical devices.
The duration and location of the study is of no importance.
For example GLP applies to short term experiments as well as to long
term studies. And if a pharmaceutical company subcontracts part of a
study to a university, that university still must comply with the
same requirements as the sponsor company. Some laboratories tried to
get away from GLP through outsourcing, but I can tell you this does
Facility Management and Other Personnel
Qualification of Personnel
Like all regulations also GLPs have chapters on personnel.
The assumption is that in order to conduct GLP studies with the
right quality a couple of things are important:* Number one there
should be sufficient people and second, the personnel should be
The FDA is not specific at all what type of qualification or
education people should have. Qualification can come from education,
experience or additional trainings, but it should be documented.
This also requires a good documentation of the job descriptions, the
tasks and responsibilities.
Responsibilities of facility management are
well defined. They include to designate a study director and also to
monitor the progress of the study and if it is not going well to
replace the study director.
management is responsible for many things, basically they should
assure that a quality assurance unit is available, test and control
articles are characterized, and that sufficient qualified personnel
is available for the study.
Because it is obvious that
management can not take care personally about all this they have to
rely on other functions, for example GLPs require that the QA should
give a regular report on the compliance status of the study.
The position of a study director is unique for GLP. He/she has
overall responsibility for the technical conduct of the safety
studies, as well as for the interpretation, analysis, documentation
and reporting of the results. He or she is designated by and
receives support from management. The study director serves as the
single point of study control. It is important that this is a single
individual person and not a department or any other grouping of
people. An assistant study director is not permitted but there may
be an alternate study director who serves as study director only in
that person’s absence.
The study director may be the laboratory manager and may be
responsible for more than one study. However, he or she should not
be over-burdened—an auditor could otherwise get the impression that
the study director cannot monitor all studies carefully.
xxx See Table from old version!!!
Quality Assurance Unit
The quality assurance unit (QAU) serves an internal control
function. It is responsible for monitoring each study to assure
management that facilities, equipment, personnel, methods,
practices, records, controls, SOPs, final reports (for data
integrity), and archives are in conformance with the GLP/GALP
regulations. For any given study, the QAU is entirely separate from
and independent of the personnel engaged in the direction and
conduct of that study.
As well as immediately reporting of any problems, GLP/GALP
regulations require the QAU to maintain and periodically submit to
laboratory management comprehensive written records listing findings
and problems, actions recommended and taken, and scheduled dates for
inspection. A designated representative from the FDA or EPA may ask
to see the written procedures established for the QAU’s inspection
and may request the laboratory’s management to certify that
inspections are being implemented, and followed-up in accordance
with the regulations governing the QAU.
Part-time or full-time personnel may be used depending on whether
the volume of work is sufficient to justify employing one or more
full-time quality assurance professionals. Full-time professionals
are the preferred arrangement, because such an arrangement provides
a degree of independence and removes the possibility that the
demands of the person’s second job will interfere with his or her
performance of the QA function. For small organizations it might not
be possible to designate a full-time person.
The FDA mandates that responsibilities and procedures applicable
to the QAU, the records maintained by the QAU, and the method of
indexing such records be in writing and be maintained. The agency
further requires that these items, including inspection dates, the
description of the study inspected, the phase or segment of the
study, and the name of the individual performing the inspection, be
made available for review by an authorized FDA agent. The FDA agent
cannot request the findings of the QAU audit .
Main Responsibilities of the Quality Assurance Unit
Maintain copy of master schedule sheet of all studies conducted.
These are to be indexed by test article and must contain the test
system, nature of study, date the study was initiated, current
status of each study, identity of the sponsor, and name of the study
Maintain copies of all protocols pertaining to the studies for
which QAU is responsible.
Inspect studies at intervals adequate to assure the integrity of the
study and maintain written and properly signed records of each
periodic inspection. These records must show the date of the
inspection, the study inspected, the phase or segment of the study
inspected, the person performing the inspection, findings and
problems, action recommended and taken to resolve existing problems,
and any scheduled date for re-inspection. Any problems discovered
which are likely to affect study integrity are to be brought to the
attention of the study director and management immediately.
Periodically submit to management and the study director written
status reports on each study, noting problems and corrective actions
Determine whether deviations from protocols and SOPs were made with
proper authorization and documentation.
Review the final study report to assure that it accurately
describes the methods and SOPs and that the reported results
accurately reflect the raw data of the study.
Prepare and sign a statement to be included with the final study
report that specifies the dates of audits and dates of reports to
management and to the study director.
Audit the correctness of the statement, made by the study director,
on the GLP compliance of the study.
All GLP regulations also have requirements for facilities, for
example, animal care facilities are listed as well as animal supply
facilities, facilities for handling test and control articles, and
laboratories and storage facilities. The main purpose of this is to
ensure integrity of the study and of study data. Three main
requirements for facilities are
- Limited access to buildings and rooms
- Adequate size and
- Adequate construction.
For example, if a testing facility is to small to handle the
specified volume of work there may be a risk to mix incompatible
functions. Or if the air conditioning system is wrongly designed,
there may be cross contamination between different areas.
Equipment and Computer Systems
All GLP regulations also have requirements for equipment. They
are related to design, calibration, maintenance and validation. This
includes analytical equipment such as chromatographs,
spectrophotometers, and computerized equipment for instrument
control and direct data capture, data evaluation, printing,
archiving and retrieval. .
Equipment used in generation, measurement, or assessment of data
and equipment used for facility environmental control shall be of
appropriate design and adequate capacity to function according to
the protocol and shall be suitably located for operation,
inspection, cleaning, and maintenance. The equipment should undergo
a validation process to ensure that it will consistently function as
intended. Examples are analytical equipment such as chromatographs,
spectrophotometers, computerized equipment for direct data capture,
and computers for statistical analysis of data.
Maintenance, calibration, testing and validation
Equipment shall be adequately inspected, cleaned, and maintained.
Equipment used for generation, measurement, or assessment of data
shall be adequately tested, calibrated and/or standardized. These
activities are frequently called qualification for equipment
hardware and single modules and validation for software and complete
systems. A laboratory shall establish schedules for such operations
based on manufacturer’s recommendations and laboratory experience.
Time interval for calibration, re-validation and testing
The frequency for calibration, re-validation and testing
(performance verification) depends on the instrument itself, the
recommendations from manufacturers of equipment, laboratory
experience, and the extent of use. For instance, a pH meter should
be calibrated before each use and the wavelength of an HPLC variable
wavelength detector should be calibrated about every month or
whenever the cell is removed and reinstalled. Typically proof of
chromatographic instrument performance should be done every 6 to 12
Equipment Records and Other Documents
Written records shall be maintained of all inspection,
maintenance, testing, calibrating and/or qualification / validation
operations. These records, containing the date of operation, shall
describe whether the maintenance operations followed written SOPs.
Written records shall be kept of non-routine repairs performed on
equipment as a result of failure and malfunction. Such records shall
document the nature of the defect, how and when the defect was
discovered, and any remedial action taken in response to the defect.
Written records may be in log books especially designed for that
purpose. A log book should accompany the instrument when it is
moved. Remedial action should include a review of effects on data
generated before the defect was discovered. Such equipment records
should be maintained as long as the data generated by the equipment.
Equipment records should include
- name of the equipment
- name of the manufacturer,
- model or type for identification s
- serial number
- date equipment was received in the laboratory
- condition when received (new, used)
- details of checks made for compliance with relevant
calibration or test standard specification
- date equipment was placed in service by the laboratory
- current location in the laboratory, if appropriate
- copy of manufacturer's operating instruction(s)
- details of maintenance carried out
- history of any damage, malfunction, modification or repair
- person responsible for the equipment
Important questions to be answered for any analytical
For an auditor there are several important questions to be
answered for any analytical instrument:
- What is the equipment being used for and are there
- Is the instrument within specification and is the
documentation to prove this available?
- If the instrument is not within specifications, how much
does it deviate by?
- If the instrument is not within specifications, how long has
this been the case?
- If the instrument is not within specifications what action
has been taken to overcome the defect?
- Can the standards used to test and calibrate the instruments
be traced back to national standards?
Standard Operating Procedures
Standard operating procedures (SOPs) are written procedures for a
laboratories program. They define how to carry out
protocol-specified activities. Most often they are written in a
chronological listing of action steps.
- Routine inspection, cleaning, maintenance, testing,
calibration and standardization of instruments
- Actions to be taken in response to equipment failure
- Analytical methods
- Definition of raw data
- Data handling, storage, and retrieval
- Health and safety precautions
- Receipt, identification, storage, mixing, and method
sampling of test and control articles
- Record keeping, reporting, storage, and retrieval of data
- Coding of studies, handling of data, including the use of
computerized data systems
- Operation of quality assurance personnel in performing and
reporting study audits, inspections, and final study report
SOPs should preferably be written in the laboratory close to the
instrument, and not in an office. It should be either written or
thoroughly reviewed by the instruments’ operators. SOPs should not
be written to explain how procedures are supposed to work, but how
they work. This ensures that the information is adequate and that
the document invites rather than discourages routine use.
Sops are frequently mentioned as deviations in FDA warning
letters where three major deviations come up:
- SOPs are not available
- They are not adequate or
- They are not followed.
One of the first procedures should be an SOP on writing SOPs.
This is important for consistency and efficiency. For example, it
should be defined who is responsible for initiating, authoring, and
approving SOPs and how procedures are distributed and how the use of
SOPs is enforced.
GLPs allow to deviate from SOPs but deviations should be approved
Reagents and Solutions
To ensure ongoing quality of reagents and solutions used for GLP
studies, purchasing and testing should be handled by a quality
assurance program. That also should include qualification of
All reagents and solutions in the laboratory areas shall be
labeled to indicate identity, titer or concentration, storage
requirements, and expiration date. Deteriorated or outdated reagents
and solutions shall not be used. If reagents and solutions used for
non-GLP regulated work are stored in the same room as reagents for
GLP-regulated studies, all reagents must be labeled. Reagents that
are not adequately labeled, even if not intended for use in
GLP-regulated studies, may have an adverse effect on GLP regulated
laboratory work. It is also good practice to include the Date
opened:. This can be critical for some chemicals such as ether.
Many reagents can be stored
under ambient temperature: does this mean we have to put a label on
all these? One practical recommendation to avoid too much paper work
is to have a procedure that has a sentence like this: "You don’t
need to label environmental conditions on each reagent if it is
stored under ambient temperature.” So everybody in your lab should
know: reagents and solutions without storage temperature do not
require cooling for storage
The expiration date depends on the nature of the chemical. Sodium
chloride has practically no expiration date. In these cases it might
be acceptable to indicate NONE or Not applicable (N/A) on the label
for expiration date. The laboratory must be prepared to justify this
designation. Formal studies are not always required to justify
assigned expiration dates. It is sufficient to assign expiration
dates based on literature references and/or laboratory experience.
Test and Control Articles
Control articles or reference substances as they re called in the
OECD principles are of utmost importance because they are commonly
used to calibrate the instrument. The accuracy of the reference
substances also determines the accuracy of the analytical method. In
other words, if the reference standard is wrong, also the test
Main requirements for control articles are:
The identity, strength,
purity, composition and other characteristics should be determined
for each batch and documented. * Methods of synthesis, fabrication,
or derivation of test and control articles should also be
documented. Copies of this documentation must be stored with the
study data and must be available for FDA inspection.
In addition, the stability of each test or control article should
be determined. This can be done either before study initiation, or
simultaneously according to written SOPs which provide for periodic
reanalysis of each batch.
Each storage container for a test or control article should be
labeled by name, chemical abstract number or code number, batch
number, expiration date, and, where appropriate, storage conditions
necessary to maintain the identity, strength, purity and
containers should be assigned to a particular test article for the
length of the study.
Certified reference standards can be purchased from appropriate
suppliers. If standards are not available, the recommendation is to
take a lot of your own material, and analyze, certify and use it as
However, they should be made from high purity
material and be compared against the primary standard to ensure the
traceability chain. For the comparison, validated test methods
should be used.
Conduct of a Study, Study Protocol and
Each GLP study should be conducted according to a study protocol.
The study director writes the study protocol to document what should
be done and when, it also describes anticipated exceptions from
SOPs. Most important is the description of the experimental design
and the type and frequency of tests and analyses. The study protocol
also documents which records should be archived and available for
As a minimum the study protocol should include:
- Title and statement of the purpose of the study
- Identification of test and control article *
- Identification of test system
- Name of the sponsor,
- Description of experimental design,
- Type and frequency of tests and analyses
- Records to be maintained
Conduct of a Study
The study should follow strictly the protocol and any deviations
should be documented, if there are any. This section also
includes requirements on how hand-recorded data and data captured
from automated equipment should be recorded. For example, hand
written data must be recorded in ink and not with a pencil. Changes
must not obscure the original entry but and must be dated and signed
together with a reason for the change.
When data are acquired from an automated system, the person
responsible for the system and the system itself should be
identified and documented.
GLP regulations specify what should be recorded. Examples
- Name and address of the laboratory
- Objectives and procedures
- Statistical methods
- Test and control articles, incl. stability data
- Description of methods
- Description of test system
- Description of dosage, route of administration, duration
- Name of the study director
- Location where raw specimens and data are stored
- Descriptions of transformations and calculations
Most of requirements are quite obvious, but let’s look at the
last bullet:. GLP inspectors want to see on how final results have
been derived from raw data. This means to document it on paper when
you use a calculator, it also can mean to store the formulas as part
of an Excel spreadsheet, or for commercial systems formulas are
included in the operation manual. Sometimes software companies don’t
disclose calculations used in their software to protect intellectual
proprietary. This usually did not appear to be a big problem as long
as you document it.
Retention and Retrieval of
GLPs have several paragraphs with details on how to store and
retrieve records and data, for example, what should be archived and
What should be archived
The list of documents that should be archived includes everything
from raw data to final results, but also protocols from meetings, if
decisions related to the integrity of a study have been made.
GLPs require the position of an archivist. This is either a part
time or full time person who is responsible for the archive. Some
companies have a procedure that requires documents from an archive
to only be checked out by the archivist or his designate. Whenever
documents are taken out of the archive this should be documented,
and the person who requests it should sign a statement that nothing
has been changed, added or deleted.
GLPs also specify for how long records and specimens should be
For example, in the US material supporting FDA submissions should be
- 2 years after FDA approval or
- 5 years after FDA submission
For wet specimens may be shorter: they should only be retained as
long as the quality affords evaluation However, this is only for US
FDA and retention times in other countries may be different.
The numbers such as 2 and 5 years don't look as a long time.
However, two years are after FDA approval and 5 years are after an
FDA submission can be a long time. Sometimes it may take ten
or more years between the time GLP studies have been conducted and
approved by the FDA.
GLP says you can keep either the original or an exact copy of a
record. An exact copy can be a copy of an instable thermo paper to
durable plain paper or when paper records are scanned into TIF or
Responsibility for Archiving
The sponsor company is responsible for the records. When a
sponsor company out-sources studies or also just the archiving part,
the sponsor company must make sure that archiving of records
complies with GLP regulations and in case the contractor goes out of
business the sponsor company has access to all data. Long archiving
time as require by GLP typically is no problem for normal paper
records, but it may be one for electronic records, especially when
records are archived as original records in the proprietary
applications format. Examples are chromatographic or spectroscopic
data. So the question is always whether electronic records can be
printed and the original records can be deleted. For this discussion
we take a closer look into the definition of raw data.
GLPs also have specific requirements for raw data. They are
defined as any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the results of original observations
and activities of a study. The term covers all data necessary for
the reconstruction of the report of the study. Raw data may include
hand-written notes, photographs, microfiche copies, computer
print-outs, magnetic media, dictated observations, and recorded data
from automated instruments.
Examples also include records of animal receipt, results of
environmental monitoring, instrument calibration records, and
integrator output from analytical equipment. Raw data may also be
entries in a worksheet used to read and note information from an LED
display of an analytical instrument.
Raw data are well defined as long as information is recorded on
paper. For example original observations are recoded on paper and
exact copies can be made if necessary. A more frequently discussed
question is what is an exact copy of a paper print-out that comes
from an electronic record. Most important here is to look again at
the definition of an exact copy: as long as the print-out includes
everything that is necessary to reconstruct the study, there should
not be a problem. Or as an FDA professional explained to a
conference audience: as long as you can demonstrate compliance with
For example, one requirement of GLP is to document in an audit trail
when data have been changed. So look if the print-out includes the
audit trail information, for example when data on the computer have
been changed. An other question would be if all chromatographic peak
in the print-out are on scale?
GLP Inspections and
It is FDA’ responsibility to enforce the federal Food, drug and
Cosmetic Act to ensure safety and effectiveness of drugs and medical
devices. This is enforced through regulations, guidance documents
and FDA inspections. The FDA has the responsibility to inspect GLP
studies related to products that are marketed in the United States,
it does not matter where the products are developed or manufactured.
The FDA has developed an inspection program with two types of
inspections: Routine inspections and ‘For cause’ inspections.
Routine inspections should be conducted at least every second year.
It is an on-going evaluation of a laboratory’s compliance with GLP
For cause inspections are less frequent, they constitute only
about 20% of all GLP inspections. Reasons for such inspections could
be a follow up of an inspection with serious deficiencies or when
the FDA suspect non-compliance when investigating NDA applications.
It also may happen that the FDA gets some hints from external
sources about non-compliance in laboratories.
Typically the FDA does not announce GLP inspections. If a
laboratory refuses to accept FDA inspections, either in full or also
part of it, the FDA will not accept studies in support of new drug
Deviations from GLP requirements are documented in different
ways: if the inspection team finds deviations, they write them in a
specific form which has the number 483. The deviations are discussed
during the exit meeting and the laboratory can respond. Then the
lead inspector writes a full inspection report which is called:
establishment inspection report. This may be up to 20 or 30 pages.
Depending on the deviations the inspector will or will not to write
a warning letter. This letter is sent to the company’s management.
Within 14 days the company should respond with a corrective action
Links to Other Websites
international GLP regulations and guidelines
Links to FDA
Expert Advice on Selected Topics
Not yet available
Questions and Answers
Not yet available