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 samples from production Oral Bolus, Solution & Powder, QC (RM Retention), and finished product in PharmaInfo Ltd.

Responsibility

QA/QC officer or above is responsible for the 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• Control samples shall be withdrawn from each batch of product manufactured.
• The quantity of sample shall be withdrawn as per Table I

Sr. No.	Sample	Quantity of Sample is withdrawn (in Pack Size)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 model and make the entry in the raw material retention sample logbook as per Annexure No.-II
• Control Sample sticker label shall be stuck on each pack as per Annexure No.-III.
• The control sample shall proportionately represent 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 temperature monitoring record of the control sample room shall be maintained as per “SOP for Temperature & Relative Humidity Recording In Control Sample Storage Area”.

ALSO READ: SOP for Difference between Stability and Release Specification

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, the following points shall be considered wherever applicable but not limited to:

1. Appearance/Description, 
2. Packing Quality, 
3. Imprinting, 
4. Overprinting, 
5. The intactness of the 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 and 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 drug products and their components.
• The destruction record of the finished product control sample & raw material retention sample will be maintained in the ‘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

ALSO READ: SOP for General Laboratory and Control Records