PURPOSE: 

To lay down the procedure for preparing and authorizing a detailed

description of all sequences which are to occur in packaging and labeling of each product

and for each pack size and type in order to assure that correct labels, labeling and

packaging components are used.

SCOPE: 

This procedure applies for all Packaging Instructions.

 RESPONSIBILITY :

                                    The Production Manager.

                                    The Quality Assurance Officer.                     

PROCEDURE:

1. Initiate the preparation of packaging instructions for each pack size and type of each

new product.

2.Write packaging instructions in standard forms.

3.Write each packaging instruction in accordance with the standard format, describing.

a) Name of the product

b) The code number of the product in the packaged form.

c) A description of dosage form and strength.

d)The pack size expressed in terms of number or weight of the product in final container.

e)A complete list of all the packaging materials required for a standard batch size including quantities, sizes and types, with the reference number relating to the specification of each packaging material.

a)An example or reproduction of the relevant printed packaging material and specimens indicating where to apply batch number references and shelf life of the product.

b)A description of the packaging operation, including any subsidiary operations and equipment to be used.

c)Special precautions to be observed including a careful examination of the area and equipment in order to ascertain the line clearance before operation begin.

d)Details of any required preparation of packaging material.

1. Special characteristics to be measured checked and controlled during packaging and labeling operation.
2. The number of persons required to complete the packaging and labeling operation.
3. A description of the packaging operation, including any subsidiary operations and equipment to be used.
4. Special precautions to be observed including a careful examination of the area and equipment in order to ascertain the line clearance before operation begin.
5. Details of any required preparation of packaging material.

1. Special characteristics to be measured checked and controlled during packaging and labeling operation.
2. The number of persons required to complete the packaging and labeling operation.
3. Details of in-process controls with instructions for sampling and acceptance limits.
4. Details of outer packaging operations including the relevant labeling requirements.

4.Write packaging instructions in easily under stand able language and in clear and uncomplicated terms to be understood by the user.

5.Identify the packaging instructions with a code number specific to the particular product, pack and type.

6.Form a committee comprising production manager – quality assurance officer and general manager (plant) to review the packaging instructions prior to issue and to accord their concurrence.

7.Review each packaging instructions at least once in a year.

.  Distribute copies of approved packaging instructions to:

General  Manager (Plant)        –          1 copy

Quality Assurance In-charge Designate-        1 copy

Production Manager               –          1 copy

Obtain additional copy if required.

9.Retain all the superseded packaging instructions in a master file preserved in quality assurance for any reference.