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- Control samples shall be withdrawn from each batch of product manufactured.
- Quantity of sample shall be withdrawn as per Table-I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of Sample withdrawn (in Pack Size) |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
- The control sample shall be stored at temperature NMT 25°C.
- The record of temperature monitoring of the control sample room shall be maintained as per “SOP for Temperature & Relative Humidity Recording In Control Sample Storage Area”.
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:
- Appearance/Description,
- Packing Quality,
- Imprinting,
- Overprinting,
- The intactness of package,
- delamination,
- 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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