RECEIPT AND MAINTAINANCE OF CONTROL SAMPLE

1.0. PURPOSE:
To provide a procedure for collection, receipt, maintenance and destruction of control samples.
2.0. SCOPE:
To retain / maintain control samples of each batch of finished product and from each consignment of raw material.
3.0. RESPONSIBILITY:
Quality control chemist
4.0. ACCOUNTABILITY:
Manager-Quality Control
5.0. DEFINITION:
Control sample is a representative sample of analyzed and approved material of each batch/ consignment.
6.0. PROCEDURE:
6.1. Control sample shall represent the whole batch.
6.2. A quantity of sample sufficient for at least three complete analysis is drawn from each batch of finished product and from each consignment of raw materials as “Control Sample”.
6.3. Control sample shall be kept for at least one year after the expiry of the product.
6.4. All control sample must be stored between 20-25°C and daily temperature to be recorded in a temperature log sheet.
6.5. QA shall collect control samples of all finished products during packing.
6.6. The collection of the samples from all the batches can be ensured by QA by checking the register before the release of finished product. Incase of a non-receipt of Control Sample, an incident report is raised and samples are collected from packed shipper randomly.
6.7. After receipt of Control Samples from QA, entry must be made in Control Sample Inward Register by QA/QC personnel and transferred to Control Sample room immediately.
6.8. All Control Samples must be affixed with “ CONTROL SAMPLE NOT FOR SALE” sticker on the outer as well as inner pack.
6.9. The control sample are recorded in BMR and is considered for reconciliation of BMR.
6.10. Incase of withdrawal of control sample for investigation or registration purpose the same must be entered in the control sample stock register by QC chemist with suitable reasons.
6.11. The control sample room shall be kept under lock and key. The key shall be kept with QC in- charge or concerned chemist.
6.12. The Control sample are arranged on the racks as per product and batch wise.
6.13. Beside finished product control samples, the raw materials are also stored with proper labels and a register is maintained.
6.14. Concerned QC chemist checks the receipt, storage, segregation and monitor expiry of finished product.
6.15. The control samples are destroyed after one year from the date of expiry and same is recorded in the control sample destruction note. For finished product like capsules, tablets & dry syrups containers are opened, contents are put into water and disposed. Packing materials like labels, blisters, containers, cartons are cut into pieces and destroyed by burning.
7.0. REFERENCES:
Nil
8.0. ENCLOSURES:
Enclose suitable anextures
9.0. ABBREVIATIONS:
BMR-Batch Manufacturing Record