Collection And Storage Of Retained Samples Of Raw Material

1.0  OBJECTIVE:

To collect and store pre-decided sample quantity from each raw material received for the formulation plant except Acids, alkalis & solvents.

2.0  SCOPE:

This procedure is applicable to all raw material received for the formulation plant except Acids, alkalis & solvents.

3.0  RESPONSIBILITY:

3.1  Doing: Tech. Asst. /Executive.

3.2  Checking: Executive/ Manager.

4.0  ACCOUNTABILITY:

4.1  Head of the Department.

5.0  PROCEDURE:

5.1  Collect required quantity of retain sample from raw material received.

5.2  Take the sample in plain & black poly bags (in case if light sensitive material).

5.3  Keep this bag in the air tight plastic container.

5.4  Place the label on the plastic container having details as shown in annexure 1.

5.5  Enter the data in the ‘Retain sample register’ as per annexure 2 details.

5.6  Keep the plastic container in the box No. as specified in the register.

5.7  Store the retain sample container for 10 years as per list of storage condition available in Q.C dept.

5.8  Destroy the retain samples after 10 years.

5.9  Prepare the list of RM to be destroyed and get the approval for the same.

5.10          For destruction of retain samples soak the material in water or collect the liquid material & retain by flushing with excess if water.

5.11          Transfer the empty bottles, containers to scrap area as per Ref. SOP.

5.12          Preserve the destruction record for 5 years after the date on which they are destroyed.

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

Annexure 1: Label of retain sample.

Annexure 2: Retain sample register requirements.

 

 

Annexure: 1

Label of retain sample

RETAIN SAMPLE

Name of Material: ____________________________

Batch No.: ___________________                                  Date: ______________________

Quantity:____________________                                  A.R. No.: __________________

___________ Pharmaceuticals                                                                                                                                    

 

 

Annexure: 2

Retain sample register requirements

RETAIN SAMPLES DATA SHEET

Sr. #

Name of raw material

A.R. No.

Batch No.

Qty. sampled

Date of preparation 

Storage condition

Box No.

Sign

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

___________ Pharmaceuticals                                                                                                                                    

 

 

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

Sr.#

Serial number

Dept.

Department

RM

Raw material

Tech.

Technical

Asst.

Assistant

A.R. No.

Analytical report number

Qty.

Quantity

Sign

Signature

 

No comments:

Post a Comment