Retesting Schedule Of Raw Material

1.0  OBJECTIVE:

To ensure compliance of quality of approved raw material at regular interval during storage.

2.0  SCOPE:

This procedure is applicable for retesting of approved active and inactive raw material, which are stored in the raw material store.

3.0  RESPONSIBILITY:

3.1  Doing: Technical Assistant.

3.2  Checking: Executive/Manager.

4.0  ACCOUNTABILITY:

4.1  Head of the Department.

5.0  PROCEDURE:

5.1  On receipt of raw material, enter retesting date on MRR and in the computer system on the basis of list prepared for active & inactive RM respectively on all approved labels.

5.2  Retest due date shall not be more than expiry date of raw material.

5.3  Give two years retest due date for all materials from the date of sampling.

5.4  For the material having lower expiry date than 2 years retest period, assign the retest date for 1 year or half the period in that case.

5.5  Receive the information from the stores one month in advance for the material due for retesting.

5.6  Sample the material for retesting as per schedule as per the list received from RM store and verify against previous records.

5.7  Put the sampled stamp on the drums selected for sampling.

5.8  Affix “UNDER RETEST” label on each container and cross out “Approved” label with marker on all the containers.

5.9  Change the status of material in the computer from “Approved” to “Under test” if materials are not sampled & tested before the due date of retest.

5.10    The color of “UNDER RETEST” label is blue, and enters the following details in the

label.

5.10.1    Name of Material :

5.10.2    A.R No.                :

5.10.3    Sampled by           :

5.10.4    Date                      :

5.11          Mark “SAMPLED” stamp on containers from which the samples are collected.

5.12          Carry out the following test for each raw material as applicable.

5.12.1    Description.

5.12.2    L.O.D/Water content.

5.12.3    Chromatographic purity/Related substances.

5.12.4    Assay.

5.12.5    Microbial limit test.

5.12.6    pH/ acidity/ alkalinity test.

5.12.7    Bacterial endotoxin test.

5.13          On approval, affix “APPROVED” label with new retesting date on all the containers.

5.14          Give the new retesting date as per the list annexure I & II considering the previous

retesting due date as initial date.

5.15          If material is rejected affix “REJECTED” label on each container.

5.16          Change the status of the material in computer from “Under test” to “Approved”/

“Rejected” if status is change to under test as per point 5.9.

5.17          Prepare a test report after analysis if it conforms to specification assign a new retest

due date on approved label and get it signed by Q.C in-charge.

5.18          If the material fails, initiate the disposition of the material after due scrutiny by

concerned authorities.

5.19          Keep the record of retesting in separate file.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

01/07/2020

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

 

                                                                             


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