Change Control SOP

Change Control SOP in Pharma| SOP for Change Control in Pharmaceutical Industry | Change Control Procedure | Types of Change Control in Pharma |

• Change Control SOP covers below points:
  • Change Control definition
  • Change control procedure
  • Temporary change control
  • Permanent change control
  • Permanent change control category
    • Minor change
    • Major change
    • Critical change
  • Change Control for document
  • Change Control for Equipment / System
  • Change Control for raw material / packaging material manufacturer change
  • Change Control for packaging
  • Change Control for specification
  • Change Control Form format
  • Change Control Flow Chart

1.0 OBJECTIVE :

• To describe a procedure to deal with changes from laid down accepted practices and procedure which may affect product quality.

2.0 SCOPE :

• This SOP is applicable for the change control system in order to establish a systematic approach for notification, evaluation and implementation of changes in operating procedures, material, product, process, equipment, utilities etc.

3.0 RESPONSIBILITY :

• Chemist and above are responsible for ensuring that their action regarding the change control complies as per this SOP.
• Head of all departments are responsible to ensure that this SOP is followed.

4.0 ACCOUNTABILITY:

• Q.A. Head

5.0 PROCEDURE :

5.1 Change control is a monitoring system that ensures that a validated system remains validated. Change control is most critical aspect, as inadequate change control procedures end up creating a risk of non compliances.

5.2 Qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status. The intent is to determine the need for action that would ensure that the system is maintained in a validated state.

5.3 The person who desires to make the change in a standard practice should initiate the proposed change with relevant details and reference to current documents.

5.4 The change shall be done to improve the product quality, modify the system, installation of new system etc.

5.5 Quality Assurance Head or his/her designee in consultation with the Quality Control, Engineering, Production and Warehouse function will evaluate the impact of the change and approved by Quality Assurance Head or his/her designee.

5.6 Change classification triggers impact analysis of the proposed change for identification of impacted systems and documents. There are several risk associated with each change proposal, including reduced product quality.

5.7 After impact analysis and risk reduction, quality assurance head or his/her designee will approve or reject the change proposal based on the criticality of the proposed change. The change can be implemented after change approval by quality assurance head or his/her designee . After implementation, quality assurance head or his/her designee verifies the effectiveness of implemented changes, to confirm the change objectives were achieved and that there was no deleterious impact on product quality. After verification of change implementation, the change control can be closed.

5.8 Based on the evaluation, the decision for pilot trial or commercial batch may be taken and the change will be implemented.

5.9 The change implementation will be documented in the standard format.

5.10 If the change is suggested by the Regulatory affairs then it should be implemented immediately.

5.11 Change shall be temporary or permanent. Temporary change arises from deviation and permanent change is divided into Minor, Major and Critical change, as follows:

• Minor change: 
  • A change that may not have an impact upon the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product. For example,
    • Revision in the documents like SOPs except periodic review etc.
• Major change:
  • A change that may have an impact upon the identity, quality, purity, strength, stability, safety and efficacy or physical characteristic of the product. For example,
    • Addition or deletion of a step or addition of an alternative/new step in the process in MFR, BMR or BPR.
• Critical change:
  • A change that has a significant impact on quality and /or safety of the final product. For example,
    • Shifting of process from conventional coating pan to Autocoater,
    • Validation/Revalidation requirement,
    • Stability Study.

5.12 After change evaluation, quality assurance department will classify the change (i.e, minor/major/critical).

• Benefits of change classification includes,
  • Classification can help in assessing the impact of change in a reliable way.
  • Change classification can be used to identify risk associated with each change request.
  • Change classification can help to determine the change acceptability (i.e, reject or approve changes).

5.13 The change control procedure has the following distinct elements:

• ISSUANCE OF CHANGE CONTROL FORM:
  • As per verbal request from any departmental head or his/her designee, chemist and above of Quality Assurance department will issued blank working copy of change control form and will also get acknowledgement from requesting department on format issues register.
  • The change request department shall enter the detail in change control form.
• PRESENT STATUS: (Description of the present status)
  • The initiator describes the present status detail of Document/Process/ Equipment/Instrument/Utility machine.
• PROPOSED CHANGE : (Description of the proposed change)
  • The initiator describes the proposed change in detail for Document/Process/ Equipment/Instrument/Utility machine.
• REASON/ JUSTIFICATION  FOR CHANGE: (Reason for proposed change)
  • The initiator describes the reason/justification for the change in detail. All documents and equipment affected must be listed on the change control form.
  • Attach copies of all impacted documents, highlighting the proposed change.
  • Send the change control form to the Officer of Quality Assurance department so that a unique identifier can be assigned to the change request.
• IMPACT ASSESSMENT: (Impact of the change on product)
  • Quality Assurance Head or his/her designee evaluates the effect of change on product quality/ cost benefit, stability, validation, qualification, safety, machine performance, inventory, IT/computer, other including the documents affected and actions proposed in consultation with Quality Control, Engineering, Production and Warehouse function, the impact of the change and then forward to the respective head of initiating department for approval of initiated change control form.
• COMMENT FROM AFFECTED DEPARTMENT:
  • The respective Head or his/her designee forward the change control form to concerned department where it is applicable like Production, Packing, Quality Control, Engineering, Human resource, Warehouse, Regulatory, Quality Assurance, Plant Head/Designee, V.P. Technical /Designee.
  • After completing comment from concerned department the respective Head or his/her designee hand over the change control form to Quality Assurance Head or his/her designee for approval.
• APPROVAL OF A CHANGE BEFORE IMPLEMENTATION : (Independent approval of the change before implementation)
  • The Quality Assurance Head or his/her designee reviews the change request and proposed actions; amending as necessary.
  • The actions cannot be implemented until the Quality Assurance Head or his/her designee has reviewed and approved the change request and the proposed actions.
• IMPLEMENTING A CHANGE :
  • The initiator records on the change control form when the actions have been implemented.
  • The respective Head or his/her designee and the Quality Assurance Head or his/her designee review the change control form and associated evidence.

5.14 Change control form shall be Approved / Rejected within 30 days from its initiation date. In case if change control form is not approved / rejected within 30 days, proper justification has to be attached for the same.

5.15 Change control form shall be closed within 60 days from its approval date. In case if change control form is not closed within 60 days, proper justification has to be attached for the same.

5.16 Change control form shall be closed after implementation of all activities mentioned in the change control.

5.17 Once the Quality Assurance Head or his/her designee approves the change control form, the user department shall prepare relevant revised documents.

5.18 The revised document shall be approved by Quality Assurance Head or his/her designee.

5.19 User department shall implement the change, based on effective date mentioned on the documents.

5.20 The previous document master copy is stamped as ‘Obsolete’ in red ink and is kept separately for reference purpose. All the controlled copies are destroyed and record of the same is maintained.

5.21 Description of Change made in following :

• DOCUMENT:
  • Documents like Master Formula Record, Analytical specification, Raw material specifications, Packaging material specifications and Finished Products specifications, Standard Operating Procedure.
  • Any revision to documents shall be initiated by an individual or group of individuals where a need is identified, criteria being the changes must be related to quality system.
  • The changes are then done in a document and is given the revision number. The format showing history of change; for formats, SOP’s and specifications is duly filled with details regarding brief description and reason of change for the revised document and is attached along with the master copy.
  • The previous document master copy is stamped as ‘Obsolete’ in red ink and is kept separately for reference purpose. All the controlled copies are destroyed and record of the same is maintained.
• EQUIPMENT / SYSTEM :
  • In case of change to any equipment in manufacturing and packing processes or change in any approved system the following procedure is carried out.
  • The change in the equipment / system shall be initiated by the concerned departmental head, criteria being the changes must be related to quality system.
  • The request form for change in equipment / system shall be duly filled by the departmental head stating the existing system, nature of change proposed and reasons for change.
  • The effect of change on product quality and process shall be reviewed by the Quality Assurance Head or his/her designee.
  • The change shall then be reviewed and approved by the Technical Head. In case of own products, only after authorization from Technical Head the change shall be effected.
  • The Process Validation study and the Stability Study should be initiated in case of any type of system change.
  • Process change is necessitated due to change in equipment, or availability of sophisticated equipment or purchase of new equipment to replace the old one.
  • Production Head shall take the approval from Engineering Head and Quality Assurance Head.
• RAW / PACKAGING MATERIAL MANUFACTURER :
  • This is necessitated due to non- availability of material from regular manufacturer or to have multiple sources of material.
  • Quality Control Department will test the raw / packaging material and give feedback regarding the tests to Technical Head/Director.
  • Raw material is to be changed after approval of Technical Head/Director. Initial three batches using the respective (changed) Raw material are to be studied for Stability.
  • For Change in Raw material / Packaging Material in case of own Products.
    • Three vendor samples should be critically evaluated as per the specification.
    • Certificate of Analysis should be evaluated critically as per the specification.
    • Background history of vendor should be evaluated.
    • If possible vendor audit should be done or vendor check list should be sent to know the information of premises.
    • Stability data should be evaluated.
    • Data of impurities generated during the process should be asked from vendor.
• PACKAGING :
  • Packaging Change is necessitated to improve stability of products, new types of packaging components, better appearance of products and regulatory changes.
  • Change in text matter can arise as a result of change in manufacturing arrangement, regulation or marketing requirement.
• ANALYTICAL SPECIFICATION :
  • Changes in Analytical specification testing procedure are necessitated due to changes in Pharmacopoeia or regulatory changes or use of sophisticated instruments.
  • Quality Control Head or his/her designee will raise a change request along with the old and new test methods, comparative studies of results.
  • In case of own product Technical Head/Director will take decision for approving the same after reviewing the change request.
• SPECIFICATION : ( RAW MATERIALS , PACKAGING MATERIALS, SEMI FINISHED and FINISHED PRODUCTS )
  • Changes in specification are necessities due to regulatory changes.
  • Changes in specification for Raw Materials, Packaging Materials and Finished product will be done by Quality Control department.
  • Quality Control Head or his/her designee will raise a change request along with the old and new test methods and comparative studies of results.

5.22 The change control number should be assigned as follow:

• CCR/00/000.
  • Where,
  • CCR: Change Control Request,
  • 00: Year in which change requested,
  • 000: Serial Number of Report.

5.23 Change control form must be stored for 5 years for traceability and the document destroyed after 5 years by Quality Assurance department.

 6.0 ABBREVIATIONS:

Abbreviation	Expanded form
SOP	Standard Operating Procedure
Q.A.	Quality Assurance
Q.C.	Quality Control
F and D	Formulation and Development
MFR	Master Formula Record
BMR	Batch Manufacturing Record
BPR	Batch Packing Record
CCR	Change Control Request
GMP	Good Manufacturing Practices

7.0 ANNEXURES:

Annexure No.	Title
01	Format For Change Control Form
02	Format For Change Control Register
03	Format For Flow Chart of Change Control

8.0 SOP REFERENCES

• GMP Guidelines

END OF THE SOP

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ANNEXURES :

Annex. No. 01 Format For Change Control Form

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Annex. No. 02 Format For Change Control Register

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Annex. No. 03 Format For Flow Chart of Change Control

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