SOP on Change Control

1.0 Purpose: Change Control is a procedure by which changes are reviewed to ensure that system remains qualified for its purpose.

2.0 Scope: This SOP is applicable to any change(s) or addition / deletion in SOP documents, equipment, facility, deviations in the manufacturing process(es) or testing of the products manufactured in the company are subject to this change control procedure.

3.1 Change Initiator: The person who initiates the change is responsible to notify Quality Assurance Manager for proper review and approval.

3.2 Quality Assurance Manager: To determine the necessary follow up procedures such as qualification, calibration, validation , change in SOPs or manufacturing process.

4.0 Materials and Equipment: As & when required.

5.1 Any change control is to be authorized by Quality Assurance Manager before implementation.

5.2 The change initiator should notify Quality Assurance Manager for an intended change in writing.

5.3 Quality Assurance Manager will determine the appropriate follow-up action, schedule, and protocol.

5.4 No change of raw material used to manufacture a drug formulation is allowed as it may affect the quality of finished product. If there is any change in raw materials then manufacturing process should be revalidated for three consecutive batches for its consistency and quality.

5.5 If there is any change in packaging material or product’s packing style, then the change should be approved / authorized by Quality Assurance Manager before use.

5.6 Any addition / deletion in Batch Production Records should be first approved by Quality Assurance Manager.

5.7 If there is any change in raw materials, packing materials and  / or manufacturing process, stability studies must be carried out before or after authorization of change.

5.8 The effect of change (RM/PM/Equipment/Process) should be assessed and records shall include but not limited to – 

5.8.1 Changes related to any of the following – 

i.  manufacturing equipment    ii.  manufacturing process

iii. facility                                iv.  packing materials 

v.  raw materials                       vi. manufacturing formulations

vii. utility                                 viii. SOPs

ix. others

5.8.2 Proposal or justification of the change should be given.

5.8.3 Change classification – major / moderate / minor along with justification.

5.8.4 Quality Assurance approval / disapproval for change. If disapproved, justification required.

5.9 The change control is closed when change is authorized and revised.