Handling of Control samples or Reserve Samples

1.0 OBJECTIVE 

1.1 To lay down a procedure for sampling, storage, periodical inspection & destruction of control samples or Reserve Samples  

2.0 SCOPE           

2.1 This procedure shall be applicable for all finished goods manufactured at XXX company. 

3.0 RESPONSIBILITY 

3.1Chemist – Quality Assurance       

4.0 ACCOUNTABILITY 

4.1 Incharge – Quality Assurance  

5.0 PROCEDURE 

5.1SAMPLING AND STORAGE 

5.1.1 Control samples for finished products shall be collected by I.P.Q.A Chemist from each and every batch/ sub lot. 

5.1.2  Control samples for finished products shall be collected at the interval of half an hour depending on the pack profile of the product.

5.1.3  All the samples shall be stamped ‘CONTROL SAMPLE NOT FOR SALE’

5.1.4  Control samples shall be stored securely under appropriate conditions consistent with product labelling and the details shall be entered in Annexure II.

5.1.5  Temperature of control samples room shall be recorded continuously using a calibrated strip chart recorder and shall be reviewed on a daily basis. 

5.1.6 Temperature of the control samples room shall not be more than 25⁰C.

5.1.7 The quantity to be sampled for different products will be as per latest finished product control sampling plan.

5.2 PERIODICAL INSPECTION

5.2.1 The control samples from the representative batches selected from every   drug product shall   be examined visually once a year till the expiry of the product for the evidence of deterioration unless visual examination    would affect the integrity of the control samples. The parameters that are to be checked are particulate matter, discoloration and integrity of the container. 

5.2.2 Criteria for selecting representative batch shall be as follows: 

5.2.2.1 A batch with change in Primary container / closure

§  Identify Specific changes

§  Effect on the product shall be evaluated

5.2.2.2 A batch with change in formula / manufacturing process / equipment

- Change to formula, raw materials, quantities, process steps,

 significant equipment, packaging configurations.

5.2.3 Control samples shall also be inspected in case if 

5.2.3.1 A batch having market complaint(s)

5.2.3.2 A batch having a raw material from new vendor

5.2.3.3 A recalled batch

5.2.3.4 A batch with major deviations nevertheless complying with the  specification 

5.2.4 The number of batches to be taken for the study is calculated using the formula of root N+1 where ‘N’ is the total number of batches produced in the immediate preceding year.

 5.3 REQUISITION FOR CONTROL SAMPLES 

5.3.1 The requisition for control samples can be issued / accepted in case if

5.3.1.1 Analysis has to be carried out in case of market complaint.

5.3.1.2 Discrepancies observed during periodic inspection.

5.3.1.3 Product recalls  

5.3.2 The requisition shall be raised by the concerned department as per Annexure-I

5.3.3 The requisition after approval by QA incharge, the control samples as per the quantity requested shall be issued by QA and documented in Annexure No I. 

5.4 If an investigation of a finished product is required, depending upon the nature of the investigation samples are drawn from the control samples of the batch. 

5.5 An entry is made in the control samples register in the remark column about the quantity of samples taken and the purpose and also on the Format Annexure I. 

5.6 If the investigation is of non-destructive nature viz.. Clarity of the solution, particulate matter, printing mistakes of the batch etc. samples are checked for their defects and the observations are entered in a separate register. If the investigation is chemical parameters, samples are analysed and a report is made 

5.7  Simultaneously, a complete recheck of the batch record is made to see whether there  are any significant deviations in the manufacturing process. 

5.8 A detailed report is made based on the observations from the batch record and from the analytical data. In case of any non-compliance of the batch is found, the complete batch is recalled from the market and retail outlets

 5.9  DESTRUCTION:  

5.9.1 The control samples shall be taken for destruction with in one month from the due date of destruction.

5.9.2 An Material destruction note shall be raised for the products, which are due for destruction.

5.9.3 The authorization shall be obtained from Incharge Q.A for destruction of the control samples.

5.9.4 The Vials/Ampoules/PFS are removed from outer packing before destruction.

5.9.5 The vials/Ampoules/PFS are crushed in presence of QA chemist.

5.9.6 Cartons, G.B.boxes, Wrappers, Leaflets, etc. are destroyed by burning in the incinerator in presence of QA chemist.

5.9.7 The destruction details shall be recorded in the Material Destruction Note   and also in Annexure-II and filed in QA.  

6.0  ANNEXURES 

Annexure -I Requisition for control samples.

Annexure-II  Control Samples Reinspection tracking card  

7.0      CHNAGE HISTORY