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