by - OBJECTIVE
To lay down a procedure for handling of samples between QC Laboratory.
- SCOPE
This procedure is applicable for the handling of samples between.
- RESPONSIBILITIES
QC personnel : To follow the SOP
Head QC or Designee : To review and ensure implementation of SOP.
- DISTRIBUTION
Master copy :Quality Assurance Department
Controlled copy :Quality Control Department
- PROCEDURE
Procedure for sampling
Sampling of Raw material and packaging material required for use in the Beta lactum facility shall be sampled at the Beta lactum sampling booth and transported to the General laboratory for conducting specific test.
Sampling ofIn process and finish products shall be sampled by IPQA personnel and transported to the general laboratory for conducting specific test.
Samples collected for stability studies shall be transported to the general laboratory for placing in the stability chamber at the recommended storage condition as per respective stability protocol.
Transportation of samples between the laboratories.
Place all the collected samples in a thermo box container.
Monitoring of temperature.
Place a data logger for the first three instances of transporting samples and note the temperature during the transportation.
If no appreciable changeis found, then the data logger shall be avoided for further samples.
ANNEXURES
NA
ABBREVIATIONS
QC – Quality Control
QA – Quality Assurance
NA – Not applicable.
- REFERENCES
Not Applicable
- REVISION DETAILS
| S. No. | Effective Date | Details and Reason for Revision | Revision No. | Remarks |
| New | 00 | NA |
