Record Maintained By Quality Control

1.0  OBJECTIVE:

To lay down the documented procedure for record maintained by quality control department.

2.0  SCOPE:

This SOP is applicable forrecord maintained by quality control department in Pharmaceutical industry.

3.0  RESPONSIBILITY:

3.1  Q.C. Chemist/ Q.C. Officer.

4.0  ACCOUNTABILITY:

4.1  Manager-Quality Control.

4.2  Head of the Q.C Department.

5.0  PROCEDURE:

5.1  Following are control documents:

5.1.1        Standard operating procedures of Quality control department.

5.1.2        Specifications of raw material.

5.1.3        Specifications of packing material.

5.1.4        Specifications In-process/ intermediate.

5.1.5        Specifications finished product.

5.1.6        Standard test procedures of raw material.

5.1.7        Standard test procedures of packing material.

5.1.8        Standard test procedures of In-process/ intermediate.

5.1.9        Standard test procedures of finished product.

5.1.10    List of instruments.

5.2  Following are records:

5.2.1        Raw materials testing records.

5.2.2        Packing materials testing records.

5.2.3        In-process/ intermediates testing records.

5.2.4        Finished products testing records.

5.2.5        Instrument calibration records.

5.2.6        Stability study records.

5.2.7        Glassware calibration records.

5.2.8        Raw material inward logbook.

5.2.9        Raw material work sheet issuance logbook.

5.2.10    Intermediate inward logbook.

5.2.11    Intermediate work sheet issuance logbook.

5.2.12    Finished product inward logbook.

5.2.13     Finished productwork sheet issuance logbook.

5.2.14    In-process samples inward logbook.

5.2.15    Instrument uses logbooks.

5.2.16    HPLC column logbook.

5.2.17    Stability chamber logbook.

5.2.18    Laboratory cleaning logbook.

5.2.19    Volumetric solution logbook.

5.2.20    Standard reagent solution logbook.

5.2.21    Indicator logbook.

5.2.22    Retention sample logbook.

5.2.23    Logbook issuance logbook.

 

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

HPLC

Higher performance liquid chromatography

 

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