sop for control sample management


sop for control sample management

1.1 The objective of this SOP is to define the procedure for the collection, storage, periodical inspection, and destruction of control samples & to maintain the relevant Records.
2.1 This SOP is applicable for collection, storage, periodical inspection, and destruction of control samples & to maintain the relevant records of all the products being manufactured
3.1 Officer –Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager –Quality Assurance – Provide the support to the implementation of SOP and maintained the records.
4.1 Head –Quality Assurance
5.1 In-House
6.1 Hands will be thoroughly washed after completion of the destruction activity.
7.1 Specified number of labeled and finally packed containers will be randomly collected by IPQA Personnel at specified interval during it’s packing operation from the packing line and fill the requisition form as per Format
7.2 Seal of ‘CONTROL SAMPLE’ in Blue ink will be stamped on the label / strip/Carton of each container
7.3 In case of containers without carton sufficient qty. of sample taken and seal of ‘CONTROL SAMPLE’ in Blue ink will be stamped on label and packed in flow wrap polybag.
7.4 Product packed in seal of ‘CONTROL SAMPLE’ in Blue ink will be stamped on the inner surface of upper flap and outer surface of carton individually.
7.5 All the details related with the same will entered in the “Control Sample Register” as per Format
7.6 Number of containers / unit pack to be collected as per “Required Control Sample & Stability Sample Qty. Index”, given by QC.
7.7 In case of extra container collected for party sample (If applicable) more than the mentioned quantity as EXTRA SAMPLE will be segregated and stored in corrugated box having label “Extra Sample”. Number of containers to be collected & sent for this purpose will also be listed in the record as Extra Sample.
7.8 Control Samples will be stored in the Control Sample Room at temperature 15°C to 25°C.
7.9 The Control Sample Room shall be cleaned daily & the observations are noted down in the ‘Cleaning & Sanitation Record’ of the same area.
7.10 The retention date of the finished product will be counted from the keeping of the product.
7.11 Temperature Monitoring of Control Sample Room:
7.11.1 Minimum and maximum temperature to be recorded for the Control Sample Room by minimum and maximum thermometer where only temperature is monitoring.
7.11.2 Ensure that the Minimum and maximum thermometer is cleaned and calibrated.
7.11.3 The instrument must be placed in vertical position with mercury bulb at the bottom.
7.11.4 Read the temperature from minimum and maximum thermometer in the respective areas and note the same in respective record.
7.11.5 Minimum and maximum thermometer must be fixed at point as per temperature mapping report.
7.11.6 Temperature shall be recorded from morning to evening every 4 hours interval. (i.e. 9 to 10, 13:00 to 14:00 and 17: to 18:00).
7.11.7 Minimum and maximum temperature for whole day also shall be noted down.
7.11.8 Every day morning around 10 AM record the minimum and maximum temperature from minimum & maximum thermometer for 24 hrs. and reset the thermometer indicators of minimum and maximum thermometer.
7.11.9 Minimum and maximum temperature to be noted in Record for Minimum and Maximum Temperature Monitoring as per Format
7.12 Observation / Periodic Inspections
7.12.1 All the Control Sample of finished products will be visually observed after 6 months, 12 months, 24 months and 36 months for evidence of deterioration (variation in color) or any Leakages in case of finished product unless visual examination would affect the integrity of retain sample.
7.12.2 With the prior permission of Head-QA, Officer/Executive-QA will examine the retain samples either before the next observation date or whenever there is a market complaint or for relevant parameters to investigate the complaints.
7.12.3 Incase of request of issuance of any product’s any qty. of control sample, the request will be first authorized by Head-QA.
7.12.4 The control sample withdrawal detail added in “Control Sample Register” as per Format
7.12.5 QA Authorized Requested qty. of Control samples will be issued to the concerned department and take signature in received by column.
7.12.6 Investigation will be carried out for any evidence of deterioration in Control Sample.
7.12.7 All of the observations and the stock alterations will be noted in the respective Control Sample Observation Registers.
7.13 Retention Period
7.13.1 Retain the Control samples of all finished product for one year after the date of it’s expiry.
7.13.2 Note: The retain sample will not be removed for any purpose without prior permission from Head-QA.
7.14 Destruction of the Control Sample
7.14.1 After getting authorization from the Head – QA, all the shippers will be taken out from its location in the control sample room & the labels will be crossed with bold point pen/ marker pen.
7.14.2 It will be transferred in to the shippers kept aside in the control sample room in the rack identified as ‘Awaiting Destruction’.
7.14.3 The Unit cartons, PP bags, leaflets will be torn into pieces.
7.14.4 The dust caps will be removed.
7.14.5 Then all the labeled containers will be crossed & taken along with the shippers near the Cutter machine/Scrap area.
7.14.6 The shippers will be emptied.
7.14.7 The shippers, U/cartons, leaflets, poly bags & dust caps, will be put into the incinerator / device meant for burning the rejected packing material.
7.14.8 All the destroyable control samples will be destroyed in QA personnel ‘Destroyed by & Witnessed by ‘columns in the ‘Destruction Details” as per Format will be signed by the personnel taking part in respective activity.
7.15 Storage conditions must be followed strictly.
7.16 Customers control samples are to be destroyed only after the approval from their authorized representative.
7.17 “Request / Advice for Additional Quantity of FG Samples” to production as per Format
7.18 “Request / Advice for Sampling for Control & Stability Study Sample” to production as per sop

SOP : Standard Operating Procedure
QA : Quality Assurance
FG : Finished Goods
NMT : Not More Than
Mfg. : Manufacturing

Annexure No. Title of Annexure
Annexure-I Control Sample Register
Annexure-II Record for Minimum And Maximum Temperature Monitoring
Annexure-III Request / Advice for Additional Qty. Of FG Samples
Annexure-IV Request / Advice for Sampling for Control & Stability Study Sample


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