OBJECTIVE:
To lay down the procedure for the Receipt, Testing and Release of In-Process samples.
SCOPE:
This procedure is applicable for the Receipt, Testing and Release of In-Process samples.
RESPONSIBILITY:
Quality Control Officer / Executive are responsible for Receipt & testing, follow procedure as per the procedure mentioned in this SOP.
QC Head is responsible for Approval & Release and implementation and compliance of the procedure as per this SOP.
ABBREVIATIONS
SOP : Standard Operating Procedure
QC : Quality Control
COA : Certificate of Analysis
PROCEDURE:
After receiving the samples and test request from Production, enter the details in Inward Record For Inprocess Samples (Annexure I) and allot an analytical reference number.
QC chemist shall analyze the sample and enter the data and calculations in the test data sheet as per Test Data Sheet (Annexure II).
The Test data sheet format consists of the following information in the respective cells of the format as given in Annexure II.
Cell Number | Information |
01 | To write the name of product |
02 | To write reference /Specification no. |
03 | To write Batch number |
04 | To write the A.R. No. |
05 | To write the stage |
06 | To write the batch Size |
07 | To write the date of manufacturing |
08 | To write the date of Expiry |
09 | To write the date of the sampling |
10 | To write the sample quantity |
11 | To write the date of analysis |
12 | To write the date of release |
The results of the tests carried out shall be entered in the request form and duplicate copy of the same shall be sent to production. All the data and COA shall be made.
ANNEXURES/REFERENCES :
Annexure I : Inward Record For Inprocess Samples
Annexure II : Bulk/Blend Data Sheet