Good Laboratory Practice

GOOD LABORATORY PRACTICE
By/-
T.Radhika 10031S0413
CONTENTS
GOOD LABORATORY PRACTICE Non Clinical Testing Data Generation and Storage
GOOD LABORATORY PRACTICE(GLP)

Definition:
GLP embodies a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived
GLP refers to a quality system of management controlsfor research laboratories and organizations to try to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemicals (including pharmaceuticals)
WHY WAS GLP CREATED?

In the early 70s FDA became aware of cases of poor laboratory practice all over the United States. FDA decided to do an in-depth investigation on 40 toxicology labs. They discovered a lot fraudulent activities and a lot of poor lab practices. Examples of some of these poor lab practices found were 1. Equipment not been calibrated to standard form , therefore giving wrong measurements. 2. Incorrect/inaccurate accounts of the actual lab study 3. Inadequate test systems
FAMOUS EXAMPLE
One of the labs that went under such an investigation made headline news. The name of the Lab was Industrial Bio Test. It was discovered that mice that they had used to test cosmetics such as lotion and deodorants had developed cancer and died. Industrial Bio Test lab threw the dead mice and covered results deeming the products good for human consumption. Those involved in production, distribution and sales for the lab eventually served jail time.
OBJECTIVES OF GLP
GLP makes sure that the data submitted are a true reflection of the results that are obtained during the study. GLP also makes sure that data is traceable.
To promote the quality and validity of test data

Promotes international acceptance of tests. To generate data by which hazards and risks can be assessed
Four quadrants of GLP

The Management The Quality Assurance The Study Director
The National Compliance and Monitoring Authority
Management:
Ultimately responsible for ensuring full compliance throughout the facility Provide sufficient number of qualified personnel, appropriate facilities, equipment and materials for timely and proper conduct of the study To ensure that personnel clearly understand the functions they need to perform and where necessary provide training
Should appoint study director with appropriate qualifications, training and experience before the study is initiated
To ensure that SOPs are established and are being followed as required
Quality Assurance:
Brings out any deviations from observance of GLP principles in the test facility
Review the corrective actions and ensure compliance Acts as a bridge between the Management and different individual functions
Study Director:
A technical person, able to design and approve the study plan Approve the test facilities and test site Identify and appoint Principal Investigator, where required Supervise the activities during study Ensure that experimental procedures laid down are followed, samples collected as per the established sampling plans and observations are recorded to maintain the integrity of the study Ensure that all raw data generated are fully documented and recorded
National Compliance Monitoring Authority:

Established by the department of Science and Technology, Government of India, with the approval of the Union Cabinet on April 24, 2002
Conducts laboratory inspections and audits for compliance
GLP principles
Organization and Personnel
Management Sponsor Study Director Principle Investigator Study Personnel Quality assurance program Quality Assurance Personnel Facilities Test System Facilities Facilities for Test and Reference Items Equipments, reagents and Materials
Test systems
Physical/Chemical Biological Test & Reference items Standard operating procedures Performance of Study Study Plan Conduct of Study Reporting of results
Storage of Records and Reports
NON CLINICAL TESTING

Nonclinical or Pre-Clinical studies are research studies that are conducted, typically on animals, before a permit for a clinical trial on humans can be obtained Pre-clinical studies serve a vital role in the drug discovery and development processes. These studies can be used to identify lead compounds likely to possess favorable biopharmaceutic and pharmacokinetic properties in humans
Goals of non clinical testing

Hazard identification Characterization of identified toxicities Risk assessment to evaluate implications for human safety Guidance for conduct of clinical trials
Hazard identification:
Drug-related impairment of any organ Toxic effects on cardiovascular, respiratory, central nervous system contribution to tumor growth (carcinogenicity) Damage of genetic material (genotoxicity) Developmental and reproductive toxicity
Characterization of identified toxicities:

Dose dependence and relationship to exposure (toxicokinetics)
Risk assessment:
Safety margins between toxicology and efficacy studies Monitorability and reversibility of the observed toxicity Mechanism of toxicity
Guidance for clinical trials:

Estimation of a safe starting dose Parameters for clinical monitoring
Protocol for Non Clinical Laboratory Study:

Indicates the objectives and all methods for the conduct of the study Contains the following information: A descriptive title and statement of the purpose of the study Identification of test and control articles Name of the sponsor Number, body weight range, sex, source of supply, species, strain, sub strain and age of the test system
A description and identification of the diet used in the study as well as solvents, emulsifiers and/or other materials used to solubilize or suspend the test or control articles
Each dosage level, expressed in milligrams per kilogram of body weight and the method and frequency of administration Type and frequency of tests, analyses and measurements to be made Records to be maintained A statement of the proposed statistical methods to be used
Conduct of an Non Clinical Laboratory Study:

Test systems are monitored in conformity with the protocol Specimens shall be identified by test system, study, nature and date of collection All data generated shall be recorded Any change in entries shall indicate the reason for such change, dated and signed or identified at the time of change
DATA GENERATION AND STORAGE

GLPs also have 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. These should be original, signed and dated recordings that may be on any type of media
Electronic data may be regarded as the disk, CD-ROM, or similar media, provided that this material, when reintroduced to the computer and the software, can generate the images stored on the disk or electronic media in a 100% readable form The data should be recorded promptly, legibly and signed and dated, any corrections should be made in a format to allow the original record to be seen, the change described and justified where applicable, and the change signed and dated by the individual making the revision This procedure, whether on paper or via computer should have the same standards
DATA STORAGE
Documents and records of QA have to be stored for possible future examination Protection from untimely deterioration, intentional changes and willful destruction Storage organized in an orderly form so as to facilitate the retrieval of any document which may be needed Maintained in good condition in a retrievable format for at least 5 years or for 2years past the availability of the product whichever is longer
Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation
When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented GLP sets out the general conditions to ensure the continuous availability and evaluability of stored materials
GLP does not provide for a specific storage period but provides for the possibility of early disposal Quality Assurance should be involved in any decision about the removal of the stored material and their disposal by verifying the condition of these materials and thus the reasons for the final disposal
QA, through inspection and verification, will have to acknowledge the GLP compliance of the disposal procedures
References:
How to practice GMPs by P.P.Sharma Quality Assurance and Quality Management in Pharmaceutical Industry by Y.Anjaneyulu and R.Marayya Good Laboratory Practice by Jurg P. Seiler Internet

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GOOD LABORATORY PRACTICE

GOOD LABORATORY PRACTICE(GLP)

WHY WAS GLP CREATED?

To promote the quality and validity of test data

Four quadrants of GLP

The National Compliance and Monitoring Authority

National Compliance Monitoring Authority:

Storage of Records and Reports

NON CLINICAL TESTING

Goals of non clinical testing

Characterization of identified toxicities:

Guidance for clinical trials:

Protocol for Non Clinical Laboratory Study:

Conduct of an Non Clinical Laboratory Study:

DATA GENERATION AND STORAGE

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