STANDARD OPERATING PROCEDURE HANDLING OF MATERIAL TESTED DURING OUT OF CALIBRATION PERIOD

STANDARD OPERATING PROCEDURE

SUBJECT:                      HANDLING OF MATERIAL TESTED DURING OUT OF CALIBRATION PERIOD

DEPARTMENT           : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : SOP REVISION           :

1.0       OBJECTIVE:

To provide guidelines for handling of material tested during the period when the       equipment was Out of Calibration.

2.0       POLICY:

To lay down a procedure for handling of material tested during out of calibration period.

3.0       PROCEDURE:

3.1       When the equipment is found out of calibration immediately put “Instrument Out  of Order “ label and enter the date in Calibration record and inform Service Eng.

3.2       All the raw material, finished products, which had been tested and approved during the out of calibration are identified and the day the equipment was found Out of Calibration is reviewed.

3.3       Inform the service engineer and calibrate after servicing, again enter the calibrated date in the calibration record.

3.4       Control samples of random batches approved, till date when the equipment was found Out of Calibration, are retested.

3.5       The control samples to be retested are for the batches having latest batch no. to oldest Batch nos. during the period.

3.6       Batch nos. which are found on rechecking is failing Out of Specification are informed to the production and other batches in this period also should be checked.

3.7       If the deviation is not of serious nature like color of the solution etc, then the batch need not be recalled. In case the deviation is pertaining to level of Active ingredients etc the batch is to be recalled.

3.8       The matter is to be investigated and necessary action is to be taken to avoid  recurrence i.e. the revision of the frequency for the calibration.

3.9       In case of loan-licensee materials the matter is reported to the person in-charge of the contract mfg. for necessary action.

4.0       FREQUENCY: As and when required.         

5.0       RESPONSIBILITY: G.M (Q.A).

6.0       REVIEW GUIDE: Analytical records.

7.0       ANNEXURE: ------

5.0         SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x