Collection And Storage Of Retained Samples Of Raw Material

 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