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Types and Procedure of Change Control

Learn the procedure to handle the Change Control in Pharmaceuticals - Major
Changes and Minor Changes.

1. The initiating department shall initiate the change as per the change control format
2. The initiating department shall furnish the details very clearly in the form for
present process/use, proposed change, Justification & impact analysis and acceptance
3. The initiating department shall also define changes as major or minor based on
product quality or its impact on safety, health and environmental aspects. Some of the
major and minor changes are listed below: -

3.1 Major Changes

For a substance of chemical and microbiological quality evaluation.
• Addition or deletion of a step or addition of an alternative/new step in the
formulation manufacturing process.
• Addition of a new manufacturing site with modification of the formulation
manufacturing process described in the original dossier/document.
• Change in input quantities of formulation manufacturing process.
• Changes in the quality of raw material(s) or key intermediate(s) used in the
formulation manufacturing process.

3.2 Minor Changes

• Change in the administrative references (name/company name, address) of the
certificate holder.
• Change in the references (name/company name, address) of the manufacturing site.
• Change or updating of the methods of analysis used to test the substance.
• Change in the specifications of the substance.
• Change in supplier of starting and packing material.
• Change in the batch size.
• Addition of a new manufacturing site in the same site as described in the original
• Change in the documents like SOPs etc.
4. The Initiating department shall forward the proposal as per the requirement
to Formulation & Development Department for comments and clearance.
5. After giving comments/clearance, Formulation & Development shall forward the
change control form to Quality assurance department.

12. if required..01. 03…. (e.g. 03= Current year 2013 (Last two digit of current year) 7. 10. QA shall evaluate the feasibility of the change and forward the change control form to Regulatory affairs. On completion of the total procedure. Put the stamp of ‘ OBSOLETE COPY’ on the old documents.Sixth and seventh digit represents last two digits of the current year.. CC = Change control code.Third. For example. 02.999). 002.Each change control number contains seven digits. following change control no is decoded as explained.. . and forward the change to Site Quality Head. QA shall enter the details of Change in the Change control register. Regulatory affairs shall evaluate the change in terms of any need to inform customer or any updation in dossiers etc. 003…………. 9. (001 to 999) . QA shall assign the Change control number as per the procedure given below: Assigning a change control number . . 8. 11. CC-001/ 13. Site Quality Head shall receive the comment from all the concerns and takes the decision of approving or rejecting the change.6. 001= Sequential Change control Number (001. QA shall formally enter the status in Change control Register and close the Change control Procedure.First two digits represents change control code.99). . where every this change control procedure is applicable. On receipt of Change control form from F & D department. fourth and fifth digit represent sequential change control No.

material.e changes that alter specifications. A change control system provides checks and balances in the quality system by tracking. Change proposal Change Evaluation/review Change Classification . utilities. deletion of. The purpose of change control is to prevent the unintended consequences that are sometimes encountered when making a change to a product or system. intermediate or API. or modification to manufacturing facility. procedures or equipment (including Change control is a procedure that ensures changes are implemented in a controlled and coordinated manner.Change Control Procedure in Pharmaceuticals By: Pharma Tips | Views: 4394 | Date: 26-Aug-2013 Quality Assurance Change control is a CGMP concept that focuses on managing change to prevent unintended consequences. The change control program evaluate all changes that could affect the production and control of the drug product. a critical product attribute or bioavailability) require regulatory filings and prior regulatory approval. reviewing and approving the changes. Benefits of change control system  Structured and systematic approach for change management with proper change evaluation  Documenting & tracking the details of change  Routing of change requests to appropriate individuals/team for approvals  Demonstrate compliance to regulatory agencies Change control Process flow Changes can happen anytime during a product’s life cycle.Change is an inherent part of the life cycle of a pharmaceutical product. It is the most critical element in the overall quality management of pharmaceutical industry. product. In adequate change control procedures ends up in regulatory non compliance. process. Certain manufacturing changes (i. A change can be an addition to.

Change classification triggers impact analysis of the proposed change for identification of impacted systems and documents. Identification of impacted systems/documents & risk assessment Change Approval Change implementation Verification of change implementation Change control close out Change control Procedure A formal change control procedure always begins with a change proposal. The change proposal then. v Change classification can be used to identify risk associated with each change request.e reject or approve changes). After change evaluation. including reduced product quality.e minor/major/critical). evaluated by an expert team (change control committee) contributing the appropriate expertise and knowledge from relevant areas. which is initiated by user department personnel with proper justification. quality unit will classify the change (i. There are several risk associated with each change proposal.Benefits of change classification includes v Classification can help in assessing the impact of change in a reliable way. Risk assessment in . v Change classification can help to determine the change acceptability (i.

The change can be implemented after change approval by quality unit. they were slightly longer. the new pump operates more efficiently than the "old" pump and generates 10% higher RPMs than the old one. Change control procedure should ensure that the level of documentation and effort is matched to the risk associated with the change. It should be ensured that v The change control is linked to other quality system such as CAPA. A pump on a spray dryer system must be managed to control product flow rate to the dryer. Because the product is sensitive to even minor changes in this rate. v Failure to file the changes with regulatory. GMP deficiencies related to change control v Inadequate review & approval of the change by quality control unit.changing requirements of existing systems is an important aspect of producing the desired result of a change. v Includes criteria to evaluate whether changes affects regulatory filings. Thus. same manufacturer and same design was purchased to replace it --. quality unit will approve or reject the change proposal based on the criticality of the proposed change. which contaminated the product batches. . injection pressure) is different and results in failing particle size distribution of the final product.e. The pump recently failed. resulting in the generation of metal particles. However. the change control can be closed. product flow rate (i. After verification of change implementation. This longer dimension caused the pistons to come into contact with the bottom of the filling blocks. After impact analysis and risk reduction. After implementation. Although the replacement pistons had the same part number as the original pistons. A new pump of the same model. quality unit verify the effectiveness of implemented changes. Change controls for like to like changes ‘Like to like’ change – replacement of a piece of equipment by another with ideal characteristics and function. customer complaints. validation etc. v Excluding "like-for-like" changes from change control program. Let us consider another example of like-for-like change A company performed a routine replacement of the filling pump pistons. to confirm the change objectives were achieved and that there was no deleterious impact on product quality.a like-for-like change.This metal contamination resulted in the recall of several product batches. v Includes evaluation criteria for determining if changes are technically justified. the pump is considered a critical element of the process. without taking a change request because it was a “like to like” replacement (which has been a typical industry practice). v Failure to evaluate/justify the changes.

Finished Products. 3. a like-for-like change impacted product quality. Change in Utilities. Change in Batch Packing Record. Master Formula. Change in Expiry or retest date. • Change Control Procedure. some truly like-for like changes are innocuous and should be implemented without change control assessment. Standard Operating Procedure for Change Control 1. finished goods.In both the case. Change in protocol.0 Scope : This procedure is applicable for change control procedure. Any changes at related to GMP requirements but not directly related to manufacturing or testing process shall be controlled through Ankleshwar QA. Any of the changes excluding the changes in specifications. WIP. In short. In process controls. Overall: Respective department Head. 4. Thus. even for like- for like changes.qualification or other verification is needed before use.0 Responsibility : Primary: Officer / Supervisor of respective department.0 Procedure : • Components of change control Following changes are including in change control procedure. The person requesting the change should fill in the ‘Change Control form’ and submit . Change in Batch Manufacturing Record.0 Purpose : To provide instruction for change control procedure.0 Objective : To provide a documented procedure for change control procedure. an assessment is needed to determine if pre-use testing. Change in Manufacturing process including rework and re-processing. Change in Stability study protocol. BUT. analytical methods. Batch Manufacturing Records and those changes affecting the regulatory affairs shall be controlled by the corporate QA. 5. Change in drawings. processes or controls that could impact product quality should receive additional scrutiny prior to use. assessment. Change in Specification and Analytical Test Method of following: Raw materials and Packaging materials. Change in the storage condition of raw material. equipment. Change in SOP. 2. In process and Intermediates.

g. NOTE: For any proposed change it is necessary to confirm that. Quality Control to generate the specified information or data. The Q. the user department shall prepare relevant revised documents.A In charge shall verify the proposed change by a number of factors If required the Q. the proposed change will not violet the statutory to QA In charge through the department head. The Q. A In charge shall evaluate the change proposal considering the necessity for change and any other GMP aspects that will be affected by the proposed change.A In charge has the valid reasons to reject the proposal for change. If it is require to inform to statutory authority of the concern country or to the concern buyer. he / she can reject the change proposal and intimate the requester about the same. than only proposed change shall be implemented. . The revised document shall be approved by QA in charge. it is necessary to first get approval from statutory authority of the concern country or from the buyer. he / she shall direct the requester or any other related departments e. QA personnel shall coordinate with corporate QA for the proposed change. User department shall implement the change. The QA In charge shall forward the change control form with his/ her remark or suggestions to the corporate QA. If proposed change is in the purview of Corporate QA. If the Q.A In charge shall direct the changes to Corporate QA If the supporting data is not sufficient. based on effective date mentioned on the documents. Once the QA department approves the change control form. The person requesting the change shall add any reasons or justification with adequate supporting data for the change to the ‘Change Control form”. The Q.A In charge shall approve the change and shall forward the request to corporate QA for their evaluation & suggestions if required.