SOP on withdrawal, storage, observation & destruction of control/retention sample

SOP on withdrawal, storage, observation & destruction of control/retention sample

Objective:

To lay down the procedure for withdrawal, storage, observation & destruction of control/retention sample from production (Oral & Injectable), Q.C. (RM Retention) .

Scope:

This SOP is applicable for the withdrawal, storage, observation & destruction of control samples from production (Oral & Injectable), and Q.C. (RM Retention) of the formulation plant.

Responsibility:

Quality Assurance Officer or above is responsible for the withdrawal, storage, observation & destruction of the control sample.

Accountability:

Head – QA shall be accountable for the compliance of the SOP.

Procedure:

Withdrawal of control sample:

Control samples shall be withdrawn from each batch of product manufactured.

The quantity of the control sample shall be withdrawn as per Table-1.

Tablet-1

S.No.	Sample	Quantity of sample drawn (in Unit)
1	Tablets	200
2	Capsules	200
3	Dry Syrup (Bottles)	44
4	Dry Powder injection (Vials)	128

The Q.A. person shall collect the control sample of finished goods of each product randomly covering throughout the packing operation of the same batch as per quantity mentioned in the table-1 and make the entry in the control sample logbook.

For the retention sample of Raw Materials, The Q.C. personnel shall hand over the retention sample to Q.A. personnel. The Q.A. person shall make the entry in the Raw Material control sample logbook.

After collecting the control sample, the Q.A. person shall stick the label on each carton in red color.

The control sample shall be proportionately representing from all different pack sizes in same batch like the Export / Sales / Physician sample.

The record of finished product on line control sample, reconciliation and Destruction record shall be maintained.

Storage of control sample:

The control sample shall be stored below 25°C.

The record of finished product control sample / raw material retention sample room temperature shall be maintained as per ‘SOP on monitoring of temperature, relative humidity and pressure differential.

Physical observation of the control sample:

Physical observations will be carried out after every Six months and the observation records will be maintained. for Tablets and Capsules where as for Dry Syrups and Dry Powder for Injections record will be maintained .

In case, quantity of control sample is required for testing/reference purpose, the same shall be issued only after the approval of the request. Such withdrawal shall be recorded in ‘Finished product control sample register’  and for Finished product  for Retention samples.

Destruction of control sample:

The control sample shall be destroyed after one year of expiry date. For destruction of control sample Refer ‘SOP on destruction of drugs product & its components’.

Destruction record for Finished product control sample and retention sample of raw material will be maintained respectively.

• List of Annexure / Formats :

S.No.	Format Title
1	Control samples Reconciliation, Physical observation, and Destruction record
2	Retention Samples Reconciliation, Physical observation, and Destruction record.
3	Control Sample Sticker Label
4	Control Sample / Retention Sample Requisition Slip.

 References (if any)

Not Applicable

Reason for revision

Periodic Revision.

Abbreviations

SOP: Standard Operating Procedure

QA :Quality Assurance

QC :Quality control

RM:Raw Material

Control Sample / Retention Sample Requisition Slip 

Dept.:_______________________	Date:_______________
Product Name:______________________________________
Batch No.____________                Mfd. Date:__________   Expiry Date___________
Quantity Required
Reason for withdrawal:_____________________________ Requested by/on Approved by/on

Control samples Reconciliation, Physical observation, and Destruction record

• Product :
• Storage condition: Room Temperature
• Frequency: Every six month
• Batch no. :
• Mfg. Date :
• Expiry Date :
• Strength :
• Quantity of Samples Submitted :
• Location in control sample room:
• Qty of Samples Submitted
• Samples Submitted by
• Samples Quantity Withdrawn
• Samples Withdrawn
• Reason for Withdrawing the samples
• Balance Quantity

Periodic Observations

Quantity of samples	Check 1	Check 2	Check 3	Check 4	Check 5	Check 6	Details of Discrepancy

Destruction Record of Samples

S. No	Date	Quantity Destroyed	Destroyed By	Checked By

Retention Samples Reconciliation, Physical observation, and Destruction record.

Product :

Storage condition: Room Temperature

Frequency: Every six month

Batch no. :

Mfg. Date :

Expiry Date :

Quantity of Samples Sumitted :

Location in control sample room:

Qty of Samples Submitted

Samples Submitted by (Sign&date)

Samples Checked by (Sign&date)

Quantity Withdrawn

Samples Withdrawn by (Sign&date)

Reason for Withdrawing the samples

Balance Quantity

Periodic Observations

S. No	Quantity of samples	Check 1 Sign &date	Check 2 Sign &date	Check 3 Sign &date	Check 4 Sign &date	Check 5 Sign &date	Check 6 Sign &date	Details of Discrepancy	Remarks
		OK / Not Ok	OK / Not Ok	OK / Not Ok	OK / Not Ok	OK / Not Ok	OK / Not Ok

Destruction Record of Samples

S. No	Date	Quantity Destroyed	Destroyed By	Checked By	Remarks

Periodic Observations

Quantity of samples	Check 1 Sign &date	Check 2 Sign &date	Check 3 Sign &date	Check 4 Sign &date	Check 5 Sign &date	Check 6 Sign &date	Details of Discrepancy	Remarks

Destruction Record of Samples

S. No	Date	Quantity Destroyed	Destroyed By	Checked By	Remarks

Destruction Records for control samples /Retention samples

Product Name	Batch No.	Mfg. date	Exp. Date	Rack No.	Qty. To be taken as control	Qty. To be Destructed	Destruction done	Verified By

Record for Retention Sample Inward register

• Product Name
• Batch No.
• Mfg. Date
• Exp. Date
• Qty of Samples Submitted
• Samples Submitted
• Samples Checked by
• Quantity Withdrawn
• Samples Withdrawn by
• Reason for Withdrawing the samples

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