sop for change control policy
1.0 OBJECTIVE
1.1 The objective of this SOP is to define the procedure for proposed changing, evaluation of change, approval of change in the existing document / system / facility / process etc. related to manufacturing of a product.
2.0 SCOPE
2.1 This SOP is applicable to changes in following system/process/documents etc.
2.1.1 Quality system and its documentation.
2.1.2 Manufacturing or testing equipment and instrument
2.1.3 Approved facilities/Equipments/Instruments/utilities
2.1.4 Specifications (Raw, packing, in-process, finished product-release/finished product shelf life)
2.1.5 Analytical testing method
2.1.6 Product shelf life/storage condition
2.1.7 Formulations
2.1.8 Vendors for Raw/packing materials
2.1.9 Primary, secondary packaging material, packaging configuration/style/text matter for printed packaging materials.
3.0 RESPONSIBILITY
3.1 Asst. Officer or above Quality Assurance – Prepare the SOP and follow-up the SOP accordingly.
3.2 Asst. Manager –Quality Assurance -Provide the support to the implementation of SOP and maintained the records.
4.0 ACCOUNTABILITY
4.1 Head-Quality Assurance Department / Chief Executive Officer
5.0 REFERENCE(S)
5.1 In House.
6.0 PROCEDURE
6.1 Type of Changes:
Any addition, deletion or modification in a approved system, process, materials, product, procedure, facility change, change in equipment & utility. Changes can be categorized as follows:
6.1.1 The Head of quality assurance must assign a category of change of each change control form.
6.1.2 Category “A”: Minor: A Change in a document/system/process that will not have any directly or indirectly impact on product identity, quality, purity, strength, stability, safety and efficacy or physical characteristic. E.g. typographically corrections in a document, format change of a documents for better implementation etc.
6.1.2.1 Supporting document evidences/report not required for closing of change control.
6.1.3 Category “B”: Major: A Change in a document/system/process/facility/equipment that may not have any directly impact on product but may impact indirectly on product identity, quality, purity, strength, stability, safety and efficacy or physical characteristic. E.g. Change in specification, Change in Batch Size, Change in location of equipment/facility etc.
6.1.4 Supporting document evidences/report required for closing of change control.
6.1.5 Category “C” : Critical : A Change in a document/system/process/facility/equipment that may have directly and indirectly impact on the product identity, quality, purity, strength, stability, safety and efficacy or physical characteristic. E.g. Change in formulation, Change in Excipients, Change in manufacturing equipment/facility etc.
6.1.5.1 Report for critical changes as per Format to be filled and all supporting document evidences/report shall be attached with change control form.
6.2 Identification of Changes:
6.2.1 Concerned department personnel shall identify the changes needed in the system, document, facility etc. and subsequently inform to department head.
6.2.2 The changes can be in the facility, process, specification, documentation and test procedures as mentioned below:
6.2.2.1 Facility
It includes changes in the building design, lay out, relocation or replacement of equipment, changes in water system, HVAC & all utilities.
6.2.2.2 Process
The change includes changes in batch size, master formula, process and in-process control, man and material flow.
6.2.2.3 Specification
Includes changes in specification of raw material, in-process material and finished product or any material that ultimately affects the quality of the final product.
6.2.2.4 Test Procedure:
It includes all the Standard Testing Procedure.
6.2.2.5 Documentation
BMR, BPR, Validation Protocol, VMP, SOP and other affected documents from changes.
6.3 Initiation, Review, Approval and Closing of Change Control
7.3.1 Handling of change control as per schematic diagram attached as per Format
7.3.2 After identification of change, concerned departmental person shall send requisition to QA department for issuance of “Change Control Form”.
7.3.3 QA personnel shall issue the Change Control Form as per Format by allotting change control number in sequence CCF/YYY/MM/ZZ/NNN,
Where,
7.3.3.1 CCF denotes Change Control Form,
7.3.3.2 YYY denotes Department Code (PRD= Production, QCD=Quality Control etc.).
7.3.3.3 MM stands for Month in which change control occur
7.3.3.4 ZZ stands for last two digits of current year as 15 for the year 2015, and
7.3.3.5 NNN stands for the serial no. starting from 001;
7.3.4 QA personnel shall make entry in “Change Control Log Book” as per Format
7.3.5 Change control form shall be filled by originating departmental person, reviewed by Head of concerned department and sent to Quality Assurance Department.
7.3.6 The Head of concerned department shall review these changes impact on product identity, quality, purity, strength, stability and efficacy or physical characteristics.
7.3.7 The review of a proposed change shall involve activities such as conducting experiments, analysis, review of Master documents, Stability data, etc.
7.3.8 The proposal shall be reviewed by QA Head to decide whether the change is minor, major or critical.
7.3.9 Head QA shall review the status of the documents affected by the change as given in the CCF.
7.3.10 Head QA shall approve the minor & major change in consultation with related departments.
7.3.11 If the proposed change is critical it shall be dealt with “Format For Critical Changes” as per Format
7.3.12 All the supporting documents to be attached with “Format for Critical Changes” form for review of the proposed critical changes.
7.3.13 The actions to be taken consequent to the proposed change shall also be documented and approved while approving the proposed change.
7.3.14 Where the change relates to the product manufactured for a specific customer, prior approval for this change shall be taken by QA from the customer by sending notification of the proposed change with justification. Upon receipt of acceptability from the customer views, the change shall be implemented. The views from the customer shall be taken by letter, mail or fax.
7.3.15 If the change requires permission from or intimation to regulatory authorities, it shall be notified to the authorities. Approval shall be obtained before implementation. Approved copy shall be attached with the proposed change control.
7.3.16 Based on the evaluation of the results the changes shall be made permanent.
7.3.17 Finally Head-QA shall give change approval with comments and signature.
7.3.18 After approval of proposed change, revalidation should be done whenever needed / required for the process / procedure, equipment / instruments.
7.3.19 Circulate the Change Control Form together with supporting documentation to all concerned department for information and implementation of changes. Cost/ Productivity improvements must be fully justified and counter signed by the Chief Executive Officers.
7.3.20 Following reports shall be attached with CCF (if required).
7.3.20.1 Training.
7.3.20.2 Results of validation study.
7.3.20.3 Analytical results.
7.3.20.4 Stability data.
7.3.21 As recommended by all concern department Head, Head QA and Chief Executive Officers, proposed changes shall be implemented by the initiator department.
7.3.22 After implementation of the change control proposal, necessary data shall be collected and forwarded to QA Head by the concerned department. Verification shall be carried out to ascertain whether the changes and the consequent changes have been implemented satisfactorily.
7.3.23 On the successfully implementation of proposed change Head QA shall verify the changes and close the change control by putting sign and closing date and send to Chief Executive Officers for signing.
7.3.24 After signed by Chief Executive Officers QA personnel shall entry of closing date in Change Control Log Book and circulate the Change Control Form together with supporting documentation to all concerned department for information and implementation of changes.
7.3.25 For any change control after initiation should be closed within 60 days from date of initiation.
7.3.26 If change control not closed within 60 days time period suitable reason to be provided for not closing the change control and should be close with in given time period.
Note: All supporting documents i.e. validation report (if applicable), Training record and other backup data shall be attached with change control record, and after review of all documents by Head-QA change control shall be closed.
7.0 ABBREVIATIONS
CCF : Change Control Form
QA : Quality Assurance
BPR : Batch Packing Record
BMR : Batch Manufacturing Record
VMP : Validation Master Plan
HVAC : Heating, Ventilation and Air Conditioning System
1.0 PROPOSED CHANGE APPLICABLE TO DEPARTMENT:
Production Warehouses Engineering Purchase
Quality Control Quality Assurance IT HR
1.1 PRODUCTION DEPARTMENT: (Comments if Any, related to proposed changes)
Head of production dept.: Sign. Date:
1.2 WAREHOUSE DEPARTMENT: (Comments if Any, related to proposed changes)
Head of stores dept.: Sign. Date:
1.3 ENGINEERING DEPARTMENT: (Comments if Any, related to proposed changes)
Head of Engineering dept.: Sign. Date:
1.4 PURCHASE DEPARTMENT: (Comments if Any, related to proposed changes)
Head of Purchase dept.: Sign. Date:
1.5 QUALITY CONTROL: (Comments if Any, related to proposed changes)
Head of Quality Control dept.: Sign. Date:
1.6 IT : (Comments if Any, related to proposed changes)
Head IT Sign. Date:
1.7 HUMAN RECOURSE (COMMENTS if Any, related to proposed changes)
Head of HR dept.: Sign. Date:
1.8 QUALITY ASSURANCE: (Comments if Any, related to proposed changes)
Head of Quality Assurance dept.: Sign. Date:
2.0 Evaluation of Proposed Changes :
2.1 Documents to be revised / updated / information to be furnished
Documents Name Effected Yes /No Existing Document
No. Revised Document
No. Remarks
2.1.1 BMR/ BPR/ MFR/ BOM
2.1.2 SOP /Formats
2.1.3 STS / STP
2.1.4 Validation Master Plan
2.1.5 Validation Protocol
2.1.6 Validation
2.1.7 Documentation
2.1.8 Format / Test Data Sheets
2.1.9 Stability Protocol
2.1.10 Drawing, Utility Drawings. Lay outs etc.
2.1.11 Amendment in Product Registration / Regulatory Application
2.1.12 Site Master File
2.1.13 Any Others