Change Control Procedure

1.0   OBJECTIVE

To lay down a procedure for control the changes to be made in the authorized documents, validated methods, process, procedures, facilities and equipment's.

 2.0    SCOPE

This procedure is applicable to all the departments present in the XXX, Place.

3.0    RESPONSIBILITY

3.1     Initiation: The Department in which changes are required

3.2     Review: Review from all the affected departments

3.3     Closure: Head-Quality Assurance

4.0  PROCEDURE

4.1 When the changes in the process or any other are necessary, the respective department Head shall thoroughly evaluate the changes required from the established procedure and decide up on for change control.

4.2  The initiating department shall initiate the change as per the change control format as given in Annexure-1.

4.3 The initiating department shall furnish the details very clearly in the form for present process/use, proposed change, Justification & impact analysis and acceptance criteria.

4.4 The Change Control Form with supporting documents shall be forwarded to the Quality Assurance department as per Annexure-1.

 4.5  On receipt of Change control form from the initiating department, QA shall assign the Change control number as per the procedure given below:

xxxx/CCR/XX/000-00

xxxx indicates Company Name

CCR indicates Change Control Request

XX indicates Department code

000 indicates serial Number (Starts from 001 to 999)

00 indicates last two digits of the year.          

4.6 QA shall enter the details in change Control Record given in Annexure-2

4.7  The Quality Assurance department shall define changes as major or minor based on product quality or its impact of safety, health and environmental aspects. Some of  the major and minor changes are listed below:

4.7.1  Major Changes

4.7.1.1 For a substance of chemical and microbiological quality evaluation.

 4.7.1.2  Addition or deletion of a step or addition of an alternative/new step in the formulation manufacturing process. 

4.7.1.3   Addition of a new manufacturing site with modification of the formulation manufacturing process described in the original Dossier/document.

 4.7.1.4  Change in input quantities of formulation manufacturing process.

 4.7.1.5  Changes in the quality of raw material(s) or key intermediate(s) used in the formulation manufacturing process.

 4.7.2   Minor Changes

4.7.2.1  Change in the administrative references (name/company name, address) of the certificate holder.

 4.7.2.2 Change in the references (name/company name, address) of the   manufacturing site.

 4.7.2.3 Change or updating the methods of analysis used to test the substance.

 4.7.2.4 Change in the specifications of the substance.

 4.7.2.5 Change in supplier of Raw materials and packing material.

 4.7.2.6 Change in the batch size.

 4.7.2.7 Addition of a new manufacturing site in the same site as described in the original dossier.

 4.7.2.8 Change in the documents like SOPs etc.

 4.8     Quality Assurance shall evaluate the feasibility of the changes and forward it to respective departments which are affected by the changes mentioned in the change control from.

Note: Do not forward the change control form to the departments which is not affected by the same.

4.9     Head-Quality Assurance based on the change(s) requested and comments given by Department Heads shall accept / not accept the change for implementation after discussing with affected departments.

4.10 Once the change control form is accepted, Quality Assurance shall write the list of affected documents and change the documents as per the requirement and shall issue the copy to the initiating department for implementation with copies to the other concerned departments effected.

4.11 The initiating department on receiving the accepted change control form shall arrange for updating the relevant documents and inform to Head-Quality Assurance its implementation date.

4.12 The initiating department shall coordinate with Quality Assurance department for carrying out the training to all the relevant.

4.13 Training records shall be reviewed and close the change control by Head-Quality Assurance and effective date shall be entered in Change control form.

 4.14  The original copy of the accepted change control form(s) and implementation details shall be retained by the Quality Assurance Department.

5.0     ABBREVIATIONS

5.1     CCR-Change Control Record

5.2     QA-Quality Assurance

5.3     SOP- Standard Operating Procedure

 6.0     ANNEXURE

6.1     Annexure -1: Change Control Request form

6.2     Annexure -2: Change Control Record

7.0   CHANGE HISTORY