Quality Manual: Section 5.3 - How to Maintain Accommodation and Environmental Conditions in Testing Laboratory?

 5.3        Accommodation and environmental conditions

Policy

The PTL has accommodations and an environment to facilitate the correct performance of the tests

5.3.1    PTL Laboratory facilities for testing, including but not limited to energy sources, lighting, and environmental conditions such as to facilitate the correct performance of the tests.

Technical requirements for accommodation and environmental conditions that can affect the results of tests are documented.

Lay out of the PTL laboratory has been made in such a way so as to provide sufficient accommodation for testing and easy movement, adequate lighting, power requirement & ventilation for ensuring proper conditions for testing. (Annexure 4)

















 

The environmental conditions, in which test activities are being performed, are maintained so as not to invalidate the measurements / results or adversely affect required accuracy of measurement.

 

The laboratory has been installed & designed in such a way so as to minimize effect of dust and vibration.

 

5.3.2     The PTL laboratory monitor, control and record environmental conditions as required by the relevant specifications, methods and procedures or where they influence the quality of the results, due attention is paid, for example humidity, temperature, as appropriate to the technical activities concerned. Tests are stopped when the environmental conditions jeopardize the results of the tests.

5.3.3    There are no incompatible activities in our surrounding; measures are taken to prevent cross-contamination.

5.3.4    The lab is bound to adhere to the described protocol. Only authorized personnel are allowed in the laboratory. 

5.3.5    Measures are taken to ensure good housekeeping in the laboratory; Special procedures are adopted, where necessary.

To ensure good house-keeping in the lab all the areas are specified for different activities. Almirahs / racks for storing different items before & after testing are identified. Records, Stationeries, files are kept in respective locations. The lab is cleaned daily. The lab equipments are gently cleaned by cloth on regular basis.

 

Procedure (PTL/QSP/14) for housekeeping is developed in accordance with NABL 103 (Annexure A).

 

Access to laboratory of outsiders & personnel not connected with testing activities is restricted & is being monitored.

 

Provisions for first aid, fire fighting has been made and personnel have been trained for their use.

 

Records

The record of environmental conditions like temperature and humidity is maintained.

 

 

                                                     END OF THE DOCUMENT


***********************************************************************************
You Also Like to See This:

2. PTL /QSP/02 Procedure for Document & Data Control

3. PTL /QSP/03 Procedure for Purchasing, Services, and Supplies

4. PTL /QSP/04 Procedure for Service to the Customer

5. PTL /QSP/05 Procedure for Customer Complaints

6. PTL QSP/06 Procedure for Control of Non-Conforming Testing.

7. PTL /QSP/07 Procedure for Improvement

8. PTL /QSP/08 Procedure for Corrective Action

9. PTL /QSP/09 Procedure for Preventive Action

10. PTL /QSP/10 Procedure for Control of Records

11. PTL /QSP/11 Procedure for Internal Audit

12. PTL /QSP/12 Procedure for Management Review

13. PTL /QSP/13 Procedure for Training

14. PTL /QSP/14 Procedure for Housekeeping

15. PTL /QSP/15 Procedure for Estimation of Uncertainty of measurement

16. PTL /QSP/16 Procedure for Equipment

17. PTL /QSP/17 Procedure for Measurement Traceability and Calibration

18. PTL /QSP/18 Procedure for Sampling

19. PTL /QSP/19 Procedure for Handling of Test and Calibration Items

20. PTL /QSP/20 Procedure for Assuring the Quality of Test

21. PTL /QSP/21 Procedure for Reporting of Results

22. PTL/QSP/22 Procedure for use of NABL Symbol
-----------------------------------------------------------------------------------------------------------


Note: Replace DTL with PTL for Drug Testing Laboratory.

 

 

 

 

SHARE

Owner

Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.

  • Image
  • Image
  • Image
  • Image
  • Image
    Blogger Comment
    Facebook Comment

0 comments:

Post a Comment