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

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