SOP for collection, storage and withdrawal of Retained / Reference sample.

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SOP for collection, storage and withdrawal
of Retained / Reference sample.

 

  1. what

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

2.         
why

It is the policy of ABC Pharmaceuticals 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.

3.1.2     
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 SOP.

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



CROSS REFERENCES
Standard Operating
Procedure for SOP
Awareness/ Training
on documents
Out of Specification
Results