SOP for Anaslysis and Reporting Received Sample

1.0                      Objective:

               To provide the procedure for analysis and reporting of received samples.

2.0                       Scope:

               This SOP covers all  samples, which are received in the Comapany Name 

3.0                       Responsibility:

               Jr. Research Officer /Research Officer

               Analyse the sample and record the observation of each test parameter.

               QA Officer/Manager:

               Evaluated the all data and release or rejects the sample.

               General Manager/Director:

               Authorized the final test report. 

4.0          Procedure:

4.1.          Sample packs are received from the customer for each test request for analysis.

4.2.        Enter the details of the samples in sample entry register as per given in Annexure – 1.Mark booking no. (A. R. No.) on the received sample.

4.3       After completion of receipt sample entry, department head collect the sample and test request form, check and enter the details of sample in sample analysis register as per given in Annexure – 2. 

4.4          Department Head or his designee shall arrange the analysis of sample as per the priorities.
4.5        Test each batch / lot of sample for conformance to written and approved specifications or Pharmacopoeia.

4.6               Record the observations of each test performed in the test data sheets.

4.7            After completion of the analysis and completion of data, fill up the worksheet; department head check the protocol showing all findings recorded in the worksheet along with the specification limits and the details of analysis results in sample analysis register as per given in Annexure – 2.

4.8         Submit the complete data for checking for correctness of data and conformation to the respective specification to QA Department.

4.9        After checking QA officer will send the worksheet with raw data to computer section for report preparation as per given in Annexure - 3. Finally computerized test report are again checked by QA officer and finally authorized by General Manager/Director.

4.10     After signature enter report dispatch date in the sample entry register as per given in Annexure – 1.

5.0          Documentation:

5.1          Annexure – 1           Sample Entry Register                        XXX/FRM/003-03

5.2          Annexure – 2           Sample Analysis Entry Register          XXX/FRM/004-03

5.3          Annexure – 3           Test Report 
6.0  History of Revision:

Revision No.	Effective Date	Revision details	Reason for revision

Annexure – 1
Sample Entry Register
Date	Booking No. (A. R. No.)	Name of Party	Name of Sample	Batch No.	Mfg. Date	Exp. Date	Tests to be carried out	Distribution to Department	Passing Date	Dispatch Date
SOP No. : XXX/SOP/000-00                                                                                                                                     Format No. : XXX/FRM/000-00

Annexure – 2
Sample Analysis Entry Register
Sr. No.	Date of receipt	Booking No. (A. R. No.)	Name of Sample	Batch No.	Name of Party	Test Required	Results	Date of Passing	Analysed By	Remark
SOP No. : XXX/SOP/000-00                                                                                                                                                        Format No. : XXX/FRM/000-00