In pharma industry, any proposal for change requires evaluation of the change against the marketing authorization (MA) for the product, Good Manufacturing Practice (GMP) guidelines, and patient safety.
Most importantly, consideration must be given to the impact of the change on the patient safety. This is the primary concern when managing change. Changes should drive risk reduction and reduced process variability through the product lifecycle with continual improvement and innovation.
Types of Change Control
Based on the severity, uncertainty and importance of proposed change, change control can be classified into three major categories:
- Major Change
- Moderate Change
- Minor Change
A list of changes, for which change control is required but not limited to –
Facilities
- New facilities addition
- Existing facilities modification
- Layout or design change
Equipment
- New equipment addition
- Existing equipment relocation
- Change the mode of operation
Product
- New product introduction
- Existing product reformulation
- Change of RMs and/or PMs
- Change of specification
- Change of analytical method
- Change of batch documents
- Change of storage condition
Process
- Change of manufacturing process
- Modification of manufacturing process
- Change in batch size
Documents
- Change or update of SOP
- Change or update of test method or specification
Others
- New vendor approval
- New technology implementation
Related Article: Change Control in Pharmaceutical Industry
thank you for your excellent information only one question which is
can you classify the list of changes to the type of change
for example new vendor approval which type ?
regards
It will be based on the risk assessment of proposed changes considering importance, uncertainty and complexity.
You can see the ICH Q9 guideline, where addresses what constitutes formality in QRM and it outlines how varying degrees of formality may be applied during QRM activities, including when making risk-based decisions.