SUPERVISION OF ANALYSIS SOPS

SUPERVISION OF ANALYSIS SOPS

1.0   PURPOSE

To monitor the analyst activities results accuracy and equipment performance.

2.0  SCOPE

This procedure lays down the general guide line for supervision of analysis.

3.0  RESPONSIBILITY

Ø QC Manager

Ø QC Assistant Manager

4.0   PROCEDURE

Procedure:

1.   Spot check once a week all register, reagents and reference standard solutions.

2.   Frequently observe the actual testing done by the chemist staff.

3.   Review analytical report and before signing check and confirm for:

·               Completeness of all entries

·               Whether analysis has been done, and confirm that it has performed as per the specified pharmacopoeia or in house specification (if specified)

·               If not found to comply, the Assistant Manager QC should bring to the attention of the manager quality operations so that necessary action to rectify/modify the procedure can be taken.

2.   Assistant Manager QC must scrutinize the register for completeness of all entries to date.

3.   Reagents should be stored in bottles.

4.   Reference standard solution, working standard stored in desiccators should be checked for details like name, solvent used wherever applicable, date of preparation, date of expiry, signature of person preparing.

5.   Reagent found to be having sedimentation etc. should be destroyed and self life period should be reviewed to prevent recurrence.

Assistant Manager QC must observe in person, the work carried out by the chemist staff so that feedback on the methodology followed, planning of work, accuracy, precision and efficiency their work can be enhanced.

5.0   DISTRIBUTION

Ø  Q.A Manager

Ø  Q.C Manager