STANDARD OPERATING PROCEDURE FOR COLLECTION, STORAGE AND DESTRUCTION OF CONTROL SAMPLE

1.0 OBJECTIVE

To lay down the procedure for Collection, Storage, and Destruction of control samples.

2.0 SCOPE

This SOP shall be applicable for the Collection, Storage, and Destruction of control samples.

3.0 RESPONSIBILITY

3.1 Microbiologist shall be responsible for the preparation of this SOP.

3.2 Chemist and above designee shall be responsible for execution of this SOP.

3.3 Manager QC and Manager QA shall be responsible for checking and approval this SOP.

3.4 HOD shall be responsible for authorization of SOP.

4.0 ACCOUNTABILITY

Head QC

5.0 PROCEDURE

5.1 Collection of Control Samples:

5.2 Chemist QC shall be drawn the samples from each of the approved batches during the filling/packing; at least two samples shall be collected randomly in LDPE polybags.

5.2.1 The quantity of the sample to be drawn is taken according to the QC sampling process.

5.2.2 The sample shall be stored in the control sample room.

5.2.3 The control sample shall be stored in lock and key and key shall be kept by QC in charge or Chemist.

5.2.4 The sample shall be marked as “CONTROL SAMPLE”, and entry shall be taken in Annexure I.

5.2.5 Depending upon the expiry of the product the sample are periodically examined if needed and recorded.

5.3 Storage of the control samples:

5.3.1 Control sample shall be store in the racks in a systematic manner.

5.3.2 Control sample shall be segregated product-wise.

5.3.3 Control sample shall be store in the control sample room under lock and key arrangements for a period of one year beyond the expiry of the batch in case of the finished product.

5.3.4 Ensure that the temperature and humidity of the hygrometer shall be maintained and it should not be exceeding 27 0C &relative humidity at 55% respectively.

5.4 Destruction of control sample:

5.5 Destruction of control samples shall be done as per the current SOP…………….

5.6 Destruction record shall be maintained in Annexure-II.

6.0 REFERENCE

SOP No.	Title of SOP
SOP……………………	Rejection & Destruction of IP and FP Product

7.0 ANNEXURE

Annexure No.	Title of Annexure	Format No.
Annexure I	Control Sample Record	F……………………….
Annexure II	Destruction Record of Control Sample

8.0 ABBREVIATIONS

SOP : Standard Operating Procedure

No. : Number

Dept. : Department

QCD : Quality Control Department

QA: Quality Assurance

QC : Quality Control

Mfg : Manufacturing

Exp : Expiry

Qty. : Quantity

Sr. : Senior

Temp : Temperature

0C : Degree centigrade

% : PercentageEnable GingerCannot connect to Ginger Check your internet connection
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