SOP ON GAP ASSESSMENT
PURPOSE: The purpose of this Standard Operating Procedure is to lay down the procedures for periodic review of respective standard operating procedures, Validation Procedure and other activities to find out the possibilities of improvement.
SCOPE: This SOP is applicable for review and updating of standard operating procedure, Validation Procedure and other activities to find out the possibilities of improvement in all departments at manufacturing facility.
RESPONSIBILITY:
Preparation of SOPs: Officer/Sr. officer of Quality Assurance Departments
Checking and Review of the SOPs: Sr. Officer of Quality Assurance Department
Approval of the SOPs: Executive/His Designee of Quality Assurance Department
Authorization of SOP: Head QA/ His or her Designee
ACCOUNTABILITY:
Head-QA or Designee shall be accountable for compliance of SOP.
PROCEDURE: User department and Quality assurance shall review and perform the gap assessment against the regulatory guidelines like data integrity, risk assessment, good manufacturing practices, good laboratory practices, good documentation practices, etc. to eliminate the possible non-compliances.
Gap assessment shall be carried out for specific inspection like FDA, MHRA, WHO-GMP, TGA, EU-GMP, etc. on the basis of respective regulatory guidelines.
The identified gaps shall be notified by QA department or Concern department user through a format along with change control.
Gap assessment shall be done step by step starting from purchase to finish product dispatch. Gap assessment shall be done in all departments in following steps:
Identification of Areas
Preparation of Checklist
Gap Analysis
Identification of Gaps
Corrective Action
Review of Implementation
Identification of gap closed according to the severity of the gap as seven days for high risk, 15 days for medium risk and 30 days for low risk.
QA Head shall decide if any identified gap requires risk assessment and subsequent risk mitigation plan.
In case a new regulatory requirement is introduced by the regulatory agency, a new SOP shall be prepared by respective user department or based on the feasibility and relevance, the same can be included in existing procedures.
The non – compliances issued by the regulatory agency to other organizations shall also be covered during the gap assessment and in case any gap is observed, QA Head shall decide the further course of action.
QA personnel shall allocate a twelve-digit number to the gap assessment and sign with date.
The number shall be in GA/DD/YY -001 format, where
GA: Denotes gap assessment.
DD: Denotes the Department for Example for QA: Quality Assurance
YY : Denotes the last two digit of the current Year.
The last three numerical characters are serial number starting from 001 for the year and continuing serially in increments of one unit.
The Following code numbers shall be used to identify various departments for allotting Gap Assessment Number,
Quality Assurance shall maintain the logbook of gap assessment during the Year.