Good Laboratory Practice

INTRODUCTION:

Good Laboratory Practice is a quality standard where there is an implementation of designed laboratory studies and this is reported to ensure the result is uniform, consistent, reliable and also reproducible with quality and integration of chemical nonclinical tests of safety. There are proper procedures and protocols in GLP which are to be implemented by the laboratory

GLP includes following:

1. Good laboratory management (including quality management)

2. Improved efficiency (cost reduction)

3. Errors are minimized

4. Quality control (tracking of errors and their cause)

5. Motivation given to all personnel

6. Improvement of Safety

7. Improvement of communication including internally and externally.

GLP is a quality system concerned

c) Avoids duplicative testing

d) Is beneficial to animal welfare

e) Reduces costs for industry and governments.

GLP is a regulated system. It is not only good analytical practice. It is not enough to have Good analytical practice though it is important. Taking an example of a laboratory it should consist of a particular organizational structure and protocols to carry out and document laboratory work. Traceability and integrity of data are also important along with the quality of the data. The type and amount of documentation forms the major difference between GLP and Non-GLP.

GLP inspector looks after documentation and to easily find out the following:

• Person who has done a study,

• The overall procedure on how the experiment was carried out,-

• Which procedures have been used in the experiment, and

• Any problem faced and if so

• How it has been solved.

There are few requirements of a GLP system which are as follows:

• Responsibilities should be assigned for the management of sponsor, study and quality assurance unit.

• Standard operating procedures should be defined to all the routine

• Verification and Authentication of toxicology test are done which are recorded and can be used for reconstructions.

• There is a separate department of Quality Assurance to check whether the work done has been followed in accordance with the regulations, protocols and internal procedures.

Differences has been observed as below:

• GLP has unique roles and responsibilities, including study director and principal investigator.

• .Planning and Execution of studies have been done according to approved plans.

• A list or master data schedule is maintained of all studies and protocols running in the testing facility to help coordinate the running of the studies. A regular update must be taken especially on monthly basis which is very important in GLP regulations.

• Raw data is the method used for the records generated in the course of a study.

• Formal archive is present with an archivist who is responsible for maintaining the study records stored within it.

GLP principles include

1. Principles related to organization and at personnel

• Responsibilities of the