Procedure for sampling, storage, retrieval & destruction of control sample.

1.0	PURPOSE To describe procedure for sampling, storage, retrieval and destruction of control sample.
2.0	SCOPE This procedure is applicable to all the products manufactured by Company Name.
3.0	RESPONSIBILITY IPQA Chemist
4.0	ACCOUNTABILITY  Head Quality Assurance
5.0	PROCEDURE
5.1 5.1.1 5.1.2 5.1.3 5.1.4 5.1.5 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.2.5 5.2.6 5.2.7 5.2.8 5.3 5.3.1 5.3.2 5.3.3 5.3.4 5.3.5 5.3.6 5.3.7 5.3.8 5.3.9 5.3.10 5.3.11 5.3.12 5.3.13	SAMPLE COLLECTION PROCEDURE: Control samples are considered as the representative samples of whole batch. The finished product shall be collected as in the form of pooled sample from the packing lines by Quality Assurance department during in process. Collect the sample intermittently from running packing belt to make up the required quantity in its original unit and subsequent finished pack as per Annexure-I. Record the taken quantity of control sample in BPR of same batch. Collect the control sample from each pack size of the batch in which it is being packed. STORAGE AND RETRIVAL OF CONTROL SAMPLE: Record the relevant entries in control sample register as per annexure II and affix label of “CONTROL SAMPLE ‘in red colour in each unit of sample. Place the control sample in allocated location in the racks provided in “control sample Room”. Any Control sample retrieval shall be restricted without permission from Head QA. If any case of retrieval Record the control sample retrieval as per annexure IV. Store the control sample at temperature 25 ±2°C and maintain the record as per SOP No.PIL/SOP/QA/028. Control sample shall be visually observed periodically after every 6 months from the date of manufacturing as per annexure V. Keep the control sample till shelf life of the product plus one year for Tablet, Liquid & External Products. In case of Soap, Control sample shall be kept for three months after expiry date. DESTRUCTION OF CONTROL SAMPLE: Conform the expired control sample from the control sample register. Record the expired sample details as per annexure VI. the batch of the product which have been stored for one year after shelf life and liable to be destroyed. Take out such samples from their location. Destruction of expired control sample is carried out monthly & record is kept for disposed sample along with signature of responsible person as per Annexure III. All samples are collected in separate corrugated boxes for different dosage forms i.e. Separate for solid and liquid dosage form. Department worker carries out disposal in presence of Q.A. Chemist. The samples of tablets & liquid are de-foiled / de-bottled respectively.  All solid dosage samples like powders, soap & tablets are dispersed in a bucket containing water & de-activated by treated with 2% NaOH solution. The de-bottled liquid drug products are then diluted by water & de-activated by treated with 2% NaOH solution. The treated material is then drained into ETP. Tear of the outer packing i.e., carton, catch cover, label blister strip to spoil the integerity of sample. The cut foil shall be transferred to the scrap yard. In case of liquid samples, all the bottles shall be dipped in a plastic drum containing sufficient   water to remove the labels. The Pet bottles shall be destroyed after breaking and sale it to scrap merchant. ROPP caps shall be destroyed by crushing / de-shaping them.
6.0	REFERENCES     NIL

7.0

ANNEXURES

Annexure No.	Title of Annexure	Format No.
Annexure I	QUANTITY OF CONTROL SAMPLE TO BE WITHDRAWN	QA/014/F01-02
Annexure II	CONTROL SAMPLE STORAGE LOG BOOK	QA/014/F02-01
Annexure III	CONTROL SAMPLE DESTRUCTION RECORD	QA/014/F03-00
Annexure IV	CONTROL SAMPLE RETRIEVAL RECORD	QA/014/F04-00
Annexure V	CONTRL SAMPLE PHYSICAL VERIFICATION FORMAT	QA/014/F05-00
Annexure VI	EXPIRED SAMPLE RECORD	QA/014/F06-00

8.0	ABBREVIATIONS

Abbreviations						Full Forms
SOP						Standard Operating Procedure
QA						Quality Assurance
ETP						Effluent Treatment plant
BPR						Batch Processing Record
9.0	DISTRIBUTION
Master Copy							Head Quality Assurance Department
Controlled office Copy No. 1							Head Quality Assurance Deptt.
10.0		REVISION HISTORY
S.No.			Revision No.	Effective Date	Reason for Revision			Details of Change	Authorized By (sign & Date)

                                   

Annexure I

QUANTITY OF CONTROL SAMPLE TO BE WITHDRAWN

Sr. No.	Dosage form	Pack Size	Quantity of control Sample
1	Tablets	Each Pack Size	100 Tablets per batch
2	Oral  Liquids	NMT 30 ml 31 ml- 100 ml 101 ml-499 ml 500 ml 1000 ml	15 bottle 10 Bottle 10 Bottle 2 bottle 1 bottle
3	Soap	Each Pack Size	3 Nos. per Batch
4	Ointment/Cream	Each Pack Size	10 Nos. of each pack
5	Lotion	NMT 30 ml 31 ml-150 ml 151 – 499 ml 500 ml 1000 ml	15 Bottle per batch 10 Bottle per batch 5   Bottle per batch 02 Bottle per batch 01 Bottle per batch

Annexure II

CONTROL SAMPLE STORAGE LOG BOOK

Sr. No.	Product Name	Batch. No.	Mfg. Date	Exp. Date	Pack Size	Collected Quantity	Collection Date	Collected By (Sign/Date)	Remarks

Annexure III

CONTROL SAMPLE DESTRUCTION RECORD

Sr. No.	Product Name	Batch. No.	Mfg. Date	Exp. Date	Pack Size	Destroyed Quantity	Destruction Date	Done By (Sign/Date)	Checked By	Remarks

Annexure IV

CONTROL SAMPLE RETRIEVAL RECORD

Sr. No.	Date	Product Name	Batch. No.	Mfg. Date	Exp. Date	Pack Size	No of Sample Qty	Concern Deptt	Purpose	Given By	Received BY

Annexure V

CONTRL SAMPLE PHYSICAL VERIFICATION FORMAT

Sr. No.	Product Name	Batch. No.	Mfg. Date	Exp. Date	Pack Size	No of Sample Qty	Observation of physical Character Satisfactory (Yes/No)	Checked By	Verified By

Annexure VI

EXPIRED SAMPLE RECORD

Sr. No.	Date	Product Name	Batch. No.	Mfg. Date	Exp. Date	Pack Size	Expired Sample Qty	Checked By Sign & date