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, oberservation & destruction of control / retention sample from production (Oral & Injectable), Q.C. (RM Retention) .
  • Scope:
    • This SOP applicable for withdrawal, storage, observation & destruction of control sample from production (Oral & Injectable), Q.C. (RM Retention) of formulation plant.
  • Responsibility:
    • Quality Assurance Officer or above is responsible for withdrawal, storage, observation & destruction of control sample.
  • Accountability:
    • Head – QA shall be accountable for compliance of the SOP.
  • Procedure:
    • Withdrawal of control sample:
      • Control sample shall be withdrawn from each batch of product manufactured.
      • Quantity of control sample shall be withdrawn as per Table-1.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 packing operation of same batch as per quantity mentioned in the table-1 and make the entry in control sample logbook.
  • For retention sample of Raw Material, The Q.C. personnel shall handover the retention sample to Q.A. personnel. The Q.A. person shall make the entry in Raw Material control sample logbook.
  • After collecting the control sample, Q.A. person shall stick the label on each carton in red colour.
    • The control sample shall be proportionately representing from all different pack sizes in same batch like 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 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:
  • 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  Format

   Number

           Annexure  

              Number

No. of       Pages
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 withdrawn:______________________________________________

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 Sumitted : Location in control sample room:
S.

No.

Date 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

Checked by

Sign & date

Remark

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

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:
S.

No.

Date 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

Checked by

Sign&date

Remark

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

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 Sumitted : Location in control sample room:
S.

No.

Date Qty of Samples

Submitted

Samples Submitted by

(Sign&date)

Samples

Checked by

(Sign&date)

Quantity

Withdrawn

Samples

Withdrawn by (Sign&date)

Balance

Quantity

Reason for

Withdrawing the samples

 

Checked by

Sign&date

Remark

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

Destruction Records for control samples 

Sr.

No.

Product

Name

Batch

No.

Mfg.date Exp.Date Rack

No.

Qty. To

be taken

as control

Qty. To be

Destructed

Destruction

done

By/On

Verified By Remarks (If any)
                     

Destruction Records for Retention samples

Sr.

No.

Product

Name

Batch

No.

Mfg.date Exp.Date Rack

No.

Qty. To

be taken

as control

Qty. To be

Destructed

Destruction

done

By/On

Verified By Remarks (If any)
                     

Record for Finished Product Inward register 

S.

No.

Date Product Name Batch No. Mfg. Date Exp. Date 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

Checked by

Sign&date

Rack No. Remark
                               

 

Record for Retension Sample Inward register

S.

No.

Date Product Name Batch No. Mfg. Date Exp. Date 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

Checked by

Sign&date

Rack No. Remark
                               

 

 

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