Change Control SOP
Change Control SOP describe the details procedure of handling of change in existing system, change control is Formal review, evaluation, and approval of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities, and utilities.
To establish a procedure for controlling and documenting changes. Through the provisions of this procedure, a proposed change shall be evaluated and approved internally on its scientific merit and appropriate external authorization shall be sought for those changes that impact on regulatory submissions.
This procedure shall apply to all formulation plants that manufacture, package, test, and store or distribute drug products.
Concerned department head shall be responsible for compliance of the procedure.
Head-QA shall be responsible for final approval of change control.
Abbreviations and Definitions
QA – Quality Assurance
RA – Regulatory Affairs
R&D – Research & Development
Prod. – Production
TD – Technical Directions
ROW – Rest of World
STPs – Standard testing procedures
GTPs-General testing procedures
PMS – Post marketing surveillance
HVAC – Heating, Ventilation and Air-Conditioning
Change Control – Formal review, evaluation and approval of changes to processes, procedures, specifications, analytical methods, vendors, machines, facilities and utilities.
Critical -“Critical signifies the category of the change” A critical change is a change that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a product as they may relate to the safety or effectiveness of the product.
Major – “Major signifies the category of the change” A major change is a change that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
Minor –“Minor signifies the category of the change” A minor change is a change that has minimal potential to have an adverse effect on identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.
Level-1 – “Level -1 signifies level of approval required to approve a change” Initiator department and the quality assurance department
only e.g. SOPs related to single department like operating procedure of equipment’s, cleaning procedure of equipment’s, etc.
Level-2 – “Level -2 signifies level of approval required to approve a change” Initiator department and all other interlinked departments within the plant e.g. Change in SOPs which are being followed at different departments at plant level.
Level-3–“Level -3 signifies level of approval required to approve a change” Initiator department and all other relevant departments (within plant or outside the plant) including marketing, R&D, RA and Quality and Compliance, etc. e.g. Change Controls which include change in specifications / STPs / GTPs / Artworks / License related issues / Technical directions / process change / Vendor change, etc. These type of changes may require company’s R.A. department to ask for approval of regulatory agency (ies) that have impact on regulatory dossiers submissions.
- Any change shall be proposed through a form ‘CHANGE CONTROL FORM’ (Refer annexure-1).
- Any personnel can propose a change through “CHANGE CONTROL FORM”. Personnel shall fill the details like Initiator department, Initiator (Name & Designation), proposed changes along with proper justification (Justification shall include the existing system and proposed system) and shall assess the need of training. Head of initiator department shall assess the type of change and changes required in the interlinked documents and finally countersign on the proposal.
- Head of concerned department shall categorize the change as “Critical / Major / Minor as per the definition of the changes. Once the ‘Change Control’ form has been signed by the initiator’s department head / designee, the same shall be forwarded to QA department.
Note: If documents are required from other departments, initiator department shall collect the data and submit along with the filled “Change Control Form” to QA. Refer annexure-2 for indicative data required for any type of proposed change.
- QA personnel shall evaluate the basic requirements of the change control and assess whether change control requires comments / approval from Level 1or Level 2 or Level 3 (refer abbreviations and definitions for explanations of Level 1 or Level 2 or Level 3).
- After assessment QA personnel allocates a unique number to the change control and log the same number in the “Record of Change Control” (Annexure-3). After logging the change control QA personnel shall circulate the change control for approval to different department Heads or designee.
Note: Comments on the change control can be asked from out-stationed departments through email/fax by sending the complete details of change control by any mean of communication.
- QA personnel shall allocate a nine-digit number to the change control form and sign with date. The number shall be in XCCXXX / YY format, where
X : Denotes first alphabet of site e.g. B for Baddi , D for Delhi, G for Goa and H for Hyderabad.
CC : Denotes Change Control
XXX : Serial number of change control i.e. 001, 002, 003, etc.
/ : ‘Slash’
YY : Indicate last two digits of the calendar year e.g. 23 for 2023
E.g. the third Change Control for the year 2023 for Goa site shall have a number of GCC003 /23. A new series of Change Control number shall start at the beginning of new calendar year.
- All the Department Heads or Designee shall evaluate the change control at their respective ends and give their comments (acceptable or not acceptable) on the change control form and submit back to QA department for further action plan.
- The comments shall be written by concerned / relevant department head or his designee, in his absence only (Refer annexure-4 for format of list of personnel responsible for approval of change control, this list shall be updated twice in a year on half yearly basis and shall be maintained by QA personnel).
- After receiving comments from all relevant departments Head QA or Designee shall approve or reject the change controls based on the sound scientific assessment.
Note: If a Change Control is pending for approval for more than 30 working days from the date of login, it is the discretion of Head QA or designee to approve or reject the change control.
- After approval of change control from Head QA / designee, QA personnel shall send the change intimation to all concerned department heads / designee for planning the implementation of the change control through electronic means of communications.
- After approval of change control, QA Personnel shall evaluate the implementation of the change control and shall close the change control only after all documents or any activity mentioned in the change control is closed.
Note: QA personnel shall take the re-evaluation of the change controls after every three months or need based.
- Different types of data requirements for different types of changes are enlisted in Annexure-2, but not necessarily the requirements shall be limited to this list only. If appropriate, QA head or designee may requisition any other type of data to review the proposed change(s).
- Approval from different departments shall be sought by Quality Assurance department depending upon the criticality of the change control (Please refer annexure-4 for details).
- Incase approval from any specific regulatory agency is required, Regulatory Affairs department shall co-ordinate with concerned regulatory authorities and shall give the comments / approval as per their comments.
Forms and Records
Annexure-1 : Change Control Form
Annexure-2 :Proposed Changes and Data Requirements
Annexure-3 :Record of Change Control
Annexure-4 : Format of list of personnel responsible for approval of change control
Annexure-5 :Guidance for change control
Annexure-6 :Flow chart
Master Copy – Documentation Cell (QA)
Controlled Copies -Administration and Housekeeping, Quality & Compliance, Clinical Research, Contract Manufacturing, Documentation Cell (R&D), Engineering, Exports, Finished Goods Warehouse, Human Resource, Materials Management, Production, Quality Assurance, Quality Control, Regulatory Affairs, Stores.
Reason for Revision
Change Control Form
Proposed Changes and Data Requirements
Record of Change Control
Format of list of personnel responsible for approval of change control
Guidance for change control