STANDARD OPERATING PROCEDURE INTRODUCTION OF NEW PRODUCT

STANDARD OPERATING PROCEDURE

SUBJECT: INTRODUCTION OF NEW PRODUCT

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

1.0       OBJECTIVE:

To provide guidelines for Introduction of New Product.

2.0       POLICY:

To lay down a procedure for Introduction of new product.

3.0       PROCEDURE:

3.1       Following are the points for validation before Introduction of New Product:

3.1.1    Cleaning of the Equipment.

3.1.2    Water system.

3.1.3    Manufacturing process.

3.2       CLEANING OF EQUIPMENT

3.2.1    The water is passed through the pipelines and equipment to detect any leakage and cleanliness of the parts.

3.2.2    The moving parts like stirrer is kept with running water. Then they are kept in warm water for efficient cleaning.

3.2.3    The critical areas like inner joint of the stirrer is checked for any leakage of oil and grease.

3.2.4    The shaft and gland packing of the stirrer is checked for any leakage of oil and grease.

3.2.5    The water sample from different stages is drawn and checked for color, odor & foreign matter.

3.2.6    If any such abnormality is noticed the number of waste runs are rinsed till the water samples are satisfactory.

3.2.7    All the pipe lines and equipments are sanitized using steam.

3.3       WATER SYSTEM

3.3.1    The water system must consider of “Clean in Place” subsystems having sanity fitting with ease of regeneration.

3.3.2    The water samples are drawn from different sampling points. They must meet the required specification for Chemical &Microbiological limits.

3.3.3    The Output of the water system is tested for ten working days. During this period no sample must deviate from the specifications.

3.4       MANUFACTURING PROCESS

3.4.1    The Parent company has to provide in advance to Elegant the following Information regarding

New Product.

3.4.1.1             Specification pertaining to Raw, Packing material and finished product.

3.4.1.2             Testing procedure for Raw, Packing material, finished product and In-process checks.

3.4.1.3             Manufacturing formula & Process.

3.4.1.4             Details of Utilities, Machinery and Equipment required.

3.4.1.5             Details pertaining to yield wastage of packing material left after testing and

            online rejections.

3.4.1.6             Destruction of Finished products and Packing material left after testing           and online rejections.

3.4.2    Before the onset of the Trial Mfg. batches, the cleanliness of the area and the environment

 is monitored if required. The cleanliness of the area and the environment is also monitored

during the validation period if required.

3.4.3    Once the equipment and the water system is found in order the batches are planned

3.4.4    Minimum three batches are manufactured and packed strictly as per the manufacturing and

packing instructions given by the Parent company and under the supervision of the representative. 

3.4.5    The samples are drawn and tested as per the following scheme under the supervision of Parent   

            company’s representative:

           

            EQUIPMENT             SAMPLING POINT                                       NO. Of SAMPLES

Blender                                    Top, Middle & Bottom of the Blender             3 Samples                                           

Storage tank                Top, Middle & Bottom of the tank                  3 Samples

3.4.6    All the above samples are tested for physical parameters like viscosity, uniformity of the color, flavor, specific gravity, pH etc. (depending upon the product )and the chemical parameters like active ingredients, if required , microbiological testing  too is to be done

3.4.7    There should be no variation in two results more than the laid down specifications.

3.4.8    Likewise, 3 Trial Batches are processed, sampled, tested and recorded.

4.0       FREQUENCY:  As and when new product is introduced or there is change in site or equipment

5.0       RESPONSIBILITY: Parent Company & Loan Licenses.

6.0       REVIEW GUIDE:  New Product validation data. 

7.0       ANNEXURE: ------

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

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