STANDARD OPERATING PROCEDURE CLEANING VALIDATION

STANDARD OPERATING PROCEDURE

SUBJECT:                      CLEANING VALIDATION

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

1.0       OBJECTIVE:

To provide guidelines, to check the residual water for absence of Active ingredients, colour, flavour, fragrance and taste etc. incase of liquid and creams products.

2.0       POLICY:

To establish a procedure for cleaning of validation.

3.0       PROCEDURE:

3.1       The wash water is checked for identification of the following without further dilutions, whenever there is a change of product in the manufacturing area:

           

3.1.1    Anne French Cream & Lotion: To check the colour and fragrance of perfume.

3.1.2    Abbott area: To check the colour, fragrance of perfume and Clarity of solution

3.1.3    Mintop: To check the odor of fragrance & active Ingredients content whenever there is change from one fragrance to another.

3.1.4    Ayurvedic Section:  To Check the colour, odor of fragrance whenever there is    

            a change from one product to another.

3.2       When ever there is a change over from one fragrance to another fragrance or Product change over the final rinse Wash Water of Holding tank, Makeup tanks, manufacturing tanks and nozzle of filling machine are collected and tested for organoleptic test as mentioned in the product change over approved slip.

3.2.1    Colour and clarity of wash water.

3.2.2    Odor of wash water.

3.2.3    Flavour of wash water.                                   

3.2.4    Identification for active ingredients.

           

3.3       The observations shall be recorded.

3.4       If found satisfactory change report shall be given.

3.5       If the cleaning is not satisfactory QA will direct for further washing.

The equipment are cleared for use if the content of active ingredients is less than 5 ppm per equipment for liquid products. Incase of cream the wash water should be clear, colorless and odorless.

4.0       FREQUENCY:  Batch/Product changeover.

5.0       RESPONSIBILITY: Executive Q.A.

6.0       REVIEW GUIDE: Cleaning Validation file.

7.0       ANNEXURE: 1. Product change over approval slip.

8.0       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