Understanding Change Control vs. Deviation

The formulation of a product is being adjusted to improve stability. Which documentation process should be followed?

• Change Control

• Deviation

During routine production, an operator accidentally uses the wrong cleaning agent. What should be documented?

• Change Control

• Deviation

A new piece of equipment is being installed in the manufacturing line. Which process applies?

• Change Control

• Deviation

A deviation from the standard operating procedure (SOP) occurs due to a power outage. What should be filed?

• Change Control

• Deviation

The location of a critical manufacturing step is being moved to a different facility. What process should be followed?

• Change Control

• Deviation

A batch of product does not meet its specified quality criteria during in-process testing. What process should be followed?

• Change Control

• Deviation

A new supplier has been selected for a critical raw material. What process should be initiated?

• Change Control

• Deviation

A discrepancy in the batch yield is identified after the manufacturing process is completed. What should be reported?

• Change Control

• Deviation

Updating the design of a product's primary packaging to enhance its stability. What process should be initiated?

• Change Control

• Deviation

To comply with updated regulatory guidelines, the company decides to modify its manufacturing process. What should be implemented?

• Change Control

• Deviation