Function Of Quality Control Department

 

1.0  OBJECTIVE:

To lay down the documented procedure for functions of quality control department.

2.0  SCOPE:

This SOP is applicable for role of quality control department in Pharmaceutical industry.

3.0  RESPONSIBILITY:

3.1  Q.C. Officer/Executive-Quality Control.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

4.2  Head of the Q.C Department.

5.0  PROCEDURE:

5.1  List of activities of quality control department.

5.1.1        Testing and release or rejection of all incoming raw materials, packing materials, in-process/ intermediates and finished products as per specified specifications.

5.1.2        Maintaining testing records as per standard procedures for raw materials, packing materials, in-process/ intermediates and finished products.

5.1.3        Calibration of laboratory instrument/ equipment.

5.1.4        Performing stability study.

5.1.5        Control sample storage.

5.1.6        Analytical method validation.

5.1.7        Preparation of standard volumetric solutions and maintain standardization record.

5.1.8        Maintain labeling procedure at all the stages and records.

5.1.9        Maintain working/ reference standard record of products.

5.1.10    Analysis of complaint samples as and when required.

5.1.11    To conduct technical audit/ self-inspection.

5.1.12    Follow safety norms at all the stage during handling of chemicals and using instruments.

5.1.13    Follow good laboratory practices.

 

 

6.0  REVISION LOG:

Revision No.

Effective Date

Reason

00

 

New SOP

 

7.0  REFERENCES:

7.1  Not Applicable.

8.0  ANNEXURES:

8.1  Not Applicable.

9.0  ABBREVIATIONS:

Abbreviation

Expanded Form

S

Standard operating procedure

&

And

%

percentage

 

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