Good Manufacturing Practice (GMP) Compliance Workflow

Start of the Workflow/Process.

Create a new entry in the Deviation Data Model to document a non-compliance event.

Update the Deviation entry with the current timestamp and 'In Investigation' status.

Retrieve all Standard Operating Procedures (SOPs) related to the specific manufacturing area involved in the deviation.

Create a task for the Quality Assurance specialist to perform the RCA using the 5-Whys or Fishbone method.

Calculate a risk score based on product criticality, batch volume, and regulatory impact variables.

Fetch all batch entries associated with the affected production lot.

Sum the quantity field from all retrieved batch entries to determine the total volume of potentially impacted product.

Create a task for the Production Manager to define Corrective and Preventive Actions (CAPA).

Create a new entry in the CAPA Data Model linked to the original Deviation entry.

Update the original Deviation entry status to 'Closed' once all investigations are complete.

Send an email notification to the Head of Quality containing the summary of the closed deviation.

Generate a periodic report summarizing all deviations and CAPAs closed during the current month.

Delete any duplicate or incorrectly filed deviation drafts that do not meet minimum data requirements.

Send an SMS to the On-call Supervisor if the deviation is flagged as 'Critical' during the calculation phase.

End of the Workflow/Process.