Good Laboratory Practice | SOP for GLP

 STANDARD OPERATING PROCEDURE

Company Logo	Name of the Company Unit, Address, City
TITLE	Good Laboratory Practice
SOP No.	QC-0XX	Department	Quality Control
Revision No.	0.0	Page No.	1 of end
Effective Date	DD/MM/YYYY	Revision Date	DD/MM/YYYY

1. PURPOSE

   1. To lay down a procedure for Good Laboratory Practice guidelines during the analysis at the Quality Control Department.

2. SCOPE 

1. This SOP applies to the Staff of the QC Department, who must follow the Good Laboratory Practice (GLP) guidelines implemented in the Quality Control Department at ABC Company.

3. ABBREVIATIONS/ DEFINITIONS

1. Good Laboratory Practice: GLP embodies a set of principles that provides a framework within which studies are planned, performed, monitored, recorded, reported and archived. These studies are undertaken to generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for Pharma, industrial chemicals, cosmetics, and food.

2. GLP assures regulatory authorities that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments.

4. RESPONSIBILITY

1. The user is responsible for following this procedure. 

2. HOD shall be responsible for the implementation of this procedure.

4. QA shall monitor compliance with this procedure.

5. PROCEDURE

1. Facilities:

1. Ensure that the test facility is of suitable size and location to meet the requirements of the activities carried out and minimise any disturbances.

2. Ensure that the test facility has areas for the isolation of substances or organisms suspected to be biohazardous.

3. Ensure that the facility has provisions to regulate environmental conditions such as temperature and humidity.

4. Collect, store and dispose of waste appropriately so as not to interfere with the integrity of an activity.

5. Ensure that suitable areas are available for supplies and equipment and that these areas provide protection against infestation, contamination and deterioration.

2. Personnel:

1. Ensure that each individual engaged in the conduct of or responsible for the supervision of an activity has an educational background, training and experience to enable each individual to perform the assigned functions.

2. Ensure that there is a sufficient number of personnel for the proper conduct of each activity.

3. Ensure that personnel take necessary personal protective precautions designed to avoid contamination of tests and products.

4. Ensure that individuals engaged in an activity wear appropriate clothing for the duties they are to perform.

5. Report any critical condition/s that may be considered to hurt an activity.

6. Ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions.

3. Equipment, Materials and Reagents:

1. Ensure that the equipment used in the measurement or assessment of data is suitably located, of appropriate design and of adequate capacity to function according to the activities that are carried out.

2. Periodically inspect, clean, maintain and calibrate the equipment according to each equipment’s SOP and ensure that records of such activities are maintained in each respective equipment logbook.

3. Ensure that the equipment and other materials present do not interfere with test systems.

4. The light should be adequate.

5. The electrical system in the laboratory must not be overloaded. A voltage stabilizer must be provided to protect delicate instruments.

4. Test and Reference Substances

1. Determine the identity, strength, purity and composition which define the test and reference substance and ensure that these are documented.

2. Label each storage container for the test and reference substance with name, code number, batch number, and expiry date and storage conditions.

3. Clean the working table, and instruments before & after the completion of the analysis.

4. Ensure that the temperature during dilution, at the time of volumetric measurement and standardization is maintained i. e. at about 25°C.

5. Do not enter in the areas which are restricted for entrance.

6. Label the glassware, which is in use.

7. Wipe the pipette before inserting it in the volumetric flask.

8. Make the dilutions carefully & accurately.

9. Do not use contaminated sucker/rubber bulb.

10. Make up the volume of the solution when it is at room temperature.

11. Follow the methods properly & crosscheck once.

12. Never leave any chemical reaction taking place on the gas i.e. boiling, distillation, refluxing unattended.

13. Always fill the burette taking it away from the stand into the hand and using a glass funnel. Adjust the reading to zero before starting titration.

14. Use approximately 0.1 ml of indicator, during titration or standardization, unless otherwise specified.

15. Never return unused reagents to the reagent container. Contamination of the whole reagent supply is more costly than the small amount of reagent discarded.

16. Never stick a spatula into a container of a solid reagent. Always roll the container to deliver the reagent in a controlled manner to the receiving beaker.

17. Crosscheck the exactness of the instrument method/program & sequence with respect to the method of analysis. Crosscheck the exactness of the sequence concerning the samples loaded in the autosampler.

18. Avoid glassware breakage. Upon breakage of any glassware intimate to your respective supervisor so that the requirement for the same can be raised to avoid a shortage of glassware.

19. Record the values & results online.

20. Check the entered values & figures for correctness online.

21. Calculate the results using the correct formula (as per the Method of A1nalysis) & recheck once online.

22. Do not overwrite the wrong entry. Cross it out with a line permitting the reading of the original entry. Clearly write the correct entry near the cross out & sign the data along with the date on which the correction is made.

23. Do not leave blank spaces. Draw a line across the page from left to right.

24. All the document entries shall be made with indelible blue ink in clear & legible handwriting.

25. Columns or rows not required shall be marked as ‘NA.

26. Use the correct path of the validated Excel sheet for the calculation of results.

27. Ensure that the usage and consumption entry is made in the respective instrument and column log book and working standard log book respectively.

5. Standard Operating Procedures

1. Ensure that the test facility has a set of approved and revised SOPs.

2. Review each SOP every 2 years from its date of approval or before if deemed necessary.

3. Ensure that the personnel have access to the appropriate SOPs for use during their activity and also comply with the instructions given in these documents.

4. Ensure that SOPs, manuals, published text methods and articles relative to the activities that are being undertaken are available.

5. Ensure that the latest authorized copy of each SOP is available in each laboratory.

6. Justify, document and acknowledge any deviations from an SOP.

6. ANNEXURES

1. None

7. REFERENCES

2. 21 CFR Part 58

5. REVISION HISTORY

Version no.	Effective date	Summary of revision
0.0	DD/MM/YYYY	New SOP

END O F THE DOCUMENT

                                                Prepared By               Checked By                         Approved By

Sign & Date

Name & Department               QA Executive               QC Manager                                QA Manager