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SOP for Withdrawal, Storage, Observation & Destruction of Control/Retention Sample

Objective
To lay down the procedure for withdrawal, storage, observation & destruction of control samples from production Oral Bolus, Solution & Powder, QC (RM Retention) and finished product.

Scope
This Standard Operating Procedure is applicable for withdrawal, storage, observation & destruction of control sample from production Oral Bolus, Solution & Powder, QC (RM Retention) and finished product in Pharmasky Ltd.

Responsibility
QA/QC officer or above is responsible for withdrawal, storage, observation & destruction of the control samples.

Accountability
QA/QC Head shall be accountable for the implementation of this SOP.

Procedure 

Withdrawal for Control Sample
  • Control samples shall be withdrawn from each batch of product manufactured.
  • Quantity of sample shall be withdrawn as per Table-I

Sr. No.

Sample

Quantity of Sample withdrawn (in Pack Size)

01

Bolus

Any Pack Size 1 Box

02

Powder

100 & 500 gm Pack Size 2 Pcs & 1 Kg Pack Size 1 Pc

03

Solution

100 & 500ml Pack Size 2 Pcs & 1 Liter 1 Pc

04

Suspension

100 & 500ml Pack Size 2 Pcs & 1 Liter 1 Pc

  • The QA Officer shall collect the finished product control sample from each batch throughout the packing operation as per the quantity mentioned in the table-I and make the entry in the finished product control sample logbook as per Annexure No.-I
  • For the Raw Material retention sample, the QC personnel shall collect the sample and make the entry in the raw material retention sample logbook as per Annexure No.-II
  • Control Sample sticker label shall be stick on each pack as per Annexure No.-III.
  • The control sample shall proportionately be representing all different pack sizes in the same batch sales/Physician sample’ 
  • Liquid and solvent are not retained in the control sample room.

Storage of Control Sample

Physical Observation of Control Sample
  • Physical observation will be carried out after every six months and the observation records will be maintained as per Annexure No.-V.
  • During physical observation following points shall be considered where ever applicable but not limited to:
  1. Appearance/Description, 
  2. Packing Quality, 
  3. Imprinting, 
  4. Overprinting, 
  5. The intactness of package, 
  6. delamination,
  7. Peeling/Motting of Bolus.
  • In case, a quantity of control sample/retention sample is required for testing/reference purposes, the same shall be issued only after the approval of the request as per Annexure No.-IV, such withdrawal shall be recorded in the ‘Finished product control sample logbook’ & ‘Raw material retention sample logbook ‘as per Annexure No.-I & Annexure No.-II respectively.

Destruction of Control Sample
  • The control sample & Retention sample shall be destroyed after one year of the expiry date. For the destruction of control, sample refers to ‘SOP on the destruction of drugs products and its components.
  • The destruction record of the finished product control sample & raw material retention sample will be maintained in ‘Finished product control sample logbook’ as per Annexure No.-I & ‘Raw material retention sample logbook‘ as per Annexure No.-II.

Annexure
Annexure No.-I: Finished Product Control Sample Logbook
Annexure No.-II: Raw material retention sample logbook
Annexure No.-III: Control Sample sticker label
Annexure No.-IV: Request Approval
Annexure No.-V: Physical observation records

Abbreviations
SOP: Standard Operating Procedure
QA: Quality Assurance

Revision History
Nil

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