Permanent change control procedure

Permanent Change Control is defined as a formal system by which qualified representatives of appropriate discipline reviews proposed changes that might affect a validated status. The intent to determine the need for action that would ensure that the system is maintained in a validated state. 

1. Permanent Change Control can be followed as  but not limited to: Documentation related (SOP’s, STP’s / Specifications / GTP’s, Batch Manufacturing Records / Batch Packaging Records, Formats, Validation, New Product Manufacturing, Addition of new market, Existing Product Deletion, Validation Master Plan / Site Master File, others). The Facility related (facility, equipment / Instrument, others),
2. Once the change control is initiated, the proposal for change shall be evaluated by Head or his designee of the concerned department. Appropriate data or back-up document(s), drawing(s), in support of the change proposal shall be attached with the change control proposal. The form shall clearly mention the current situation and the impact that the proposed change shall have on the documents, facility, qualification status etc.
3. Quality unit shall evaluate the proposed change and basedon the same if comments from other departments (e.g. Regulatory / Quality control / Production / Warehouse/ Engineering/Human resource/ Contract Giver/Information technology)/ other (e.g. Factory Head /Management representative etc. If required) are desired, then the form shall be forwarded to the concerned for evaluation.
4. The impact of change on environment, health and safety shall also be evaluated and addressed during change control evaluation and potential impact on filing of drug product shall be evaluated by quality unit.
5. Any quality impacting change for a product under contract manufacturing shall be intimated to Contract Giver and all communications with contract Giver including comments shall be filled along with change control.
6. Quality unit  shall determine the category of proposed change as Minor, Moderate and Major, depending on the nature and degree of change, and the effect the change could impart. Formal risk assessment shall be performed for proposed change control  for better evaluation.
7. Change control shall be categorize as minor,moderate and major it's example as bellow:

A-Minor Change: 

• A Minor change is described as a change which..
•  is unlikely to have an impact on the quality or process attributes of the  product
•  does not impact the process, significantly
• may require minimal testing and re-validation 
• has no impact on regulatory filings

B-Moderate change : A Moderate change is described as a change which..

• Is usually for improvements to process, product, procedure, materials, equipment or system
• A change which may not have an adverse effect on the quality of the product however proper evaluation is necessary
• May not affect the regulatory status of the product / process

C-Major Change : A major change..

• is described as a change which, is likely to have an impact on the critical attributes of the process, procedure or product. 
• could shift the process significantly, affecting the quality, stability, impurity profile 
• Warrants definite additional / major testing and suitable re-validation studies to justify the change 
• Introduction of new product /new market

1. While evaluating changes, especially changes pertaining to manufacturing process, batch size and testing methods, requirement of complete or partial process validation and initiation of stability studies shall be declared.
2. While evaluation of change control especially related to change in batch size, or  equipment or manufacturing process or method of analysis, consideration shall be given to magnitude of change will deciding categorization.For example....

• if the batch size is proposed to be increased, but the change involves increase in lots of same size, the categorization may be a moderate change. Only partial validation may be considered. On the other hand if the change in batch size requires change to different equipment (different occupancy or operation, etc), this shall be classified as   major change and shall involve complete validation.
• Manufacturing process changes that like shifting from compaction to direct blending shall be classified as major and shall involve complete validation along with stability studies. 
• Change in manufacturing formula would require even more critical evaluation as this would involve changes in key excipients, quantity changes, etc. Changes in  functional excipients shall trigger new process validation and stability.