SOP ON STORAGE AND WITHDRAWAL OF RETAINED/ REFERENCE SAMPLES

 

STORAGE AND
WITHDRAWAL OF RETAINED/ REFERENCE SAMPLES

1.0 What

This document details the
procedure for collection, storage and withdrawal of Retained/
Reference sample.

2.0 Why

It is the policy of ABC
Pharmaceuticals Limited that written procedures shall be followed for the
collection, storage and withdrawal of retained/reference sample in order to
ensure that sufficient quantities of retained / reference samples are collected 
that will allow a sample for analytical testing and to
provide a specimen of the fully finished product.

3.0 When

This document shall be
applicable when retained / reference samples are taken and stored within.
Also to be used as a point of reference for future on-going use.

4.0 RESPONSIBILITY

Persons
along with their responsibilities are given below:

 

S. No

Designation

Responsibility

01

Executive 
–           Corporate
Quality Assurance

To prepare and follow the SOP accordingly. Maintain
the records as per SOP.

02

Manager  
–               
Quality Control

To ensure implementation of SOP

03

Manager –
                Quality
Assurance

To ensure implementation of SOP.

04

Manager        
–      Corporate Quality Assurance

 

To ensure implementation of SOP.

 

5.0          PROCEDURE                         

5.1          FINISH PRODUCT COLLECTION and STORAGE


5.1.1      Collect the
blisters/strip/bottles equivalent to or minimum 100 tablets (depending on pack
size) for retained/reference sample.


5.1.2
      Prepare the
label for retained sample no. by following
guideline is given below.

 

Box
No.:        
             It is
sequence numbers of carton/bottle corresponding with the log.
Transfer
Date:            
This is the date on which retained sample is transferred to retained sample
room.
Disposal
Date:            
Expiry date of finish product + One year.


 

PRODUCT
RETAINED SAMPLES

BOX
NUMBER:

TRANSFER
DATE:

DISPOSAL
DATE:

 
5.1.3     Affix
this label at suitable place on cartons /bottles containing retained/reference
sample.

 

5.1.4    Place the
retained/reference sample in the shelf as identified in  Finished
  Product retained/reference sample record (Annexure I).


5.1.5      Retained/reference
sample from each batch of finished Product should be retained for at least one
year after the date of expiry.


5.1.6      If there is
any in house and/or regulatory related investigation is pending, in such cases,
retained / reference sample shall be retained till completion of
investigations.


5.2          starting material COLLECTION and STORAGE


5.2.1      Collect
retained/ reference sample of the starting materials (other than solvents or
water used in the manufacturing process).


5.2.2      Ensure that
the quantity of retained/ reference sample must be sufficient for at least two
complete analysis for all starting materials.


5.2.3      Ensure that
the quantity of retained/ reference sample must be sufficient for at least
three complete analysis for all starting materials of NAPP
Product.


5.2.4      Prepare the
Label of as per following guideline:





Product
Name:        
     B. No:

A.R.
No.:         
             Qty.:

Mfg.
Date:                    
Exp. Date:

Date
of Receipt:

Date
of Storage:

Date
of Disposal:

Sign/Date:


 
5.2.5  
Affix this label on retained/ reference sample container and place the sample
on identified shelf and record the location with appropriate detail in Starting
Material retained/ reference Sample Record (Appendix II).


5.2.6      Samples of
starting materials of each batch should be retained for at least five years
from the date of receipt.


5.2.7      If there is
any in house and/or regulatory related investigation is pending, in such cases,
retained / reference sample shall be retained till completion of
investigations.


5.3          PACKING MATERIAL COLLECTION AND STORAGE


5.3.1      Collect
retained/ reference sample of primary and printed packing materials.


5.3.2      Ensure that
the quantity of retained/ reference sample must be sufficient for at least two
complete analysis for all packing material.


5.3.3      Component of
packing materials shall be packed in a self-sealing poly bag.


5.3.4      Prepare the
label as per the following details:





Item
Name:

A.R.
No.:                  
Qty.:

Date
of Receipt:

Date
of Storage:

Date
of Disposal:

Sign/Date:


5.3.5 Affix
this label on retained/ reference sample container (self sealing poly bag) and
place in a shipper/container in retained sample room.


5.3.6 Record
the storage and disposal of packing material component as per Packing
Material retained/ reference Sample Record (Appendix-IV)


5.3.7
Retained/ reference sample of packing material shall be retained for at least
five years from the date of receipt.


5.3.8      If there is
any in house and/or regulatory related investigation is pending, in such cases,
reference sample shall be retained till completion of investigations 


5.4      
PERIODICAL VISUAL INSPECTION OF THE finished product


5.4.1  
Carry out periodic visual inspection of all finished products, after every six
months from the date of manufacturing, up to the required storage period of the
respective product


5.4.2
  Carry out visual inspection of the retained/reference sample with
respect to integrity of containers, labels, adhesion of labels on containers,
blisters or any evidence of deterioration.


5.4.3  
After visual inspection, ensure that sample is kept at its designated place.


5.4.4  
Record the observation of visual inspection on Periodic Visual Inspection
Record (Appendix III).


5.4.5  
If any evidence of deterioration is observed then immediately inform to QA
Manager and investigate it as per Out of Specification Results.


5.5          Retained /
reference sample storage condition


5.5.1  
Store the finished products /starting material under temperature NMT 25°C and
RH NMT 65%.


5.5.2   
If there is any specific requirement for a raw material as recommended by the
manufacturer, the material shall be stored as per the recommendations.


5.6          RetainED/
reference sample WITHDRAWAL


5.6.1      Whenever any
material is required to withdraw, a record of withdrawn quantity with reason
shall be maintained as per retained/ reference sample withdrawal record
(Appendix V) and report to the head of the department.

APPENDIX I

 

FINISH PRODUCT retained / REFERENCE SAMPLE RECORD

 

S.No.

Name of Product

B. No.

Mfg. Date

Exp. Date

Qty. Collected

Date of  Collection

Collected  By

Location (Shelf)

Disposal due on

Remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  

 

APPENDIX II

 

STARTING MATERIAL retained/ REFERENCE SAMPLE RECORD

 

S.No.

Name 
of  Raw Material

A.R
No.

Date
of receipt

Exp.
Date

Qty.
Collected

Date 
of  Collection

Collected 
By

Location
(Shelf)

Disposal
due on

Remarks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

APPENDIX III

 

Periodic VISUAL inspection record (FINISHed product)

 

 

Product

Name

Batch

Number

VISUAL OBSERVATION

Date

Comment

Checked By

Date

Comment

Checked By

Date

Comment

Checked By

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

APPENDIX IV

PACKING MATERIAL RETAINED/ REFERENCE
SAMPLE RECORD

S.No.

Item Name

A.R. No.

Quantity

Collected by

(Sign / Date)

Disposal

Due on

Disposed

By / Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



 

APPENDIX V

 

RETAINED/ REFERENCE SAMPLE WITHDRAWAL RECORD

 

 

S. No.

Product/Material

Batch No/ A.R. No.

Qty withdrawn

         
Reason for withdrawal

Balance Qty.

Checked by

Sign/Date

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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