Raw Material Release SOPs

Raw Material Release SOPs

1.0  OBJECTIVE:

To clearly lay down procedure for release of raw materials.

2.0  SCOPE:

This procedure is applicable for all raw materials.

3.0  RESPONSIBILITY:

3.1  Doing: Technical Assistant/ Executive.

3.2  Checking: Executive / Manager.

4.0  ACCOUNTABILITY:

4.1  Head of the Department.

5.0  PROCEDURE:

5.1  On receipt of the raw material sample from store to Q.C put into “Under Test Sample” tray kept at designated place.

5.2  Enter the details in the raw material register.

5.3  Distribute the sample for Chemical, Instrument and other tests as per specification.

5.4  Issue the photocopy of protocol and COA format for analysis from controlled computer system and put the date and signature on it.

5.5  Carry out the identification test separately for active raw material for each container.

5.6  For active raw materials perform rest of the test as per the specification from the composite sample prepared from all containers.

5.7  For active raw materials, perform the assay test from the composite sample prepared from each 10 container & report the average value in the certificate of analysis.

5.8  For inactive raw materials perform the complete testing as per specification from the composite sample prepared from the sampled containers.

5.9  Write the identification no. of instrument which is used for analysis on protocol.

5.10          Enter all results in protocol and accordingly in COA and complete the testing.

5.11          On completion of testing enter the detail in the raw material receiving report under the

heading of:

5.11.1    Approved/ rejected quantity.

5.11.2    In case of active raw material as such assay.

5.11.3    Date of release/ rejected.

5.11.4    Approved/ rejected status.

5.12          Submit material receiving report and testing report to Q.C In-charge for checking and

signing it.

5.13          Attach Q.C copy of MRR with sampling report and file it.

5.14          Check the test report, enter the detail in the register and file it.

5.15          Send remaining two copies of MRR to R.M store.

5.16          Enter the details in computer for assay (for active) and change the status to Approved/

Rejected status of respective A.R. No. by the authorized person to whom passwords

are allotted.

5.17          Take out the print out of assay status list daily. Verify by concern Executive/ Asst.

Manager & submit one copy to production in-charge & other copy to R.M store.

5.18          Print out the required no. of status label from the computer.

5.19          Enter following details for green “APPROVED” label.

A.R. No.:

Approved by     :                                                        Date:

Retest Due Date:

5.20                            In case of Rejection, write following details on red “REJECTED” label.

A.R. No.            :

Rejected  by      :                                                        Date:

Reason              :

5.21                            Paste APPROVED/ REJECTED label over the word “UNDER TEST” on yellow label.

 

6.0  REVISION LOG:

Revision No.	Effective Date	Reason
00	01/07/2021	New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

8.1  Not Applicable.

9.0  ABBREVIATIONS:

Abbreviation	Expanded Form
S	Standard operating procedure
&	And
%	Percentage