Managing GMP deviations effectively is critical to maintaining product quality, patient safety,GMP Certification cost in Kuwait and regulatory compliance. Our facility follows a well-defined, documented procedure for identifying, documenting, investigating, and resolving deviations in accordance with WHO GMP, PIC/S, and local regulatory requirements (such as those set by the Kuwait Drug and Food Control authorities).

1. Definition of a Deviation

A GMP deviation is any departure from:

• Approved procedures (SOPs, batch records, protocols)
   

• Established specifications or quality standards
   

• Expected environmental or process conditions
   

Deviations may be planned (e.g., temporary procedure changes) or unplanned (e.g., equipment failure, documentation errors, contamination, or mix-ups).

2. Immediate Documentation

When a deviation occurs:

• It is immediately reported by the person who identifies it.
   

• A Deviation Report is initiated, either electronically or manually.
   

• Key details are recorded: date, time, description, affected batch/equipment, personnel involved, GMP Certification services in Kuwait and any immediate actions taken.

Initial documentation is essential to ensure traceability and prevent recurrence or escalation.

3. Initial Assessment and Impact Evaluation

The deviation is reviewed by Quality Assurance (QA) to:

• Categorize it as minor, major, or critical
   

• Evaluate the potential impact on product quality, safety, and regulatory compliance
   

• Determine if any affected product must be quarantined or withheld from release
   

In cases of critical deviations, product release is put on hold until a full investigation is completed and reviewed.

4. Root Cause Investigation

A formal root cause analysis is conducted using tools such as:

• 5 Whys
   

• Fishbone (Ishikawa) diagrams
   

• FMEA (Failure Modes and Effects Analysis)
   

The investigation team includes representatives from production, QA, engineering, or QC, depending on the deviation’s nature.GMP Certification process in Kuwait

5. Corrective and Preventive Actions (CAPA)

Based on the investigation, appropriate Corrective and Preventive Actions are defined and implemented to:

• Address the immediate issue (corrective)
   

• Prevent recurrence (preventive)

Each CAPA action is assigned a responsible person and a due date, with progress tracked by QA.

6. Effectiveness Check and Closure

Before closing the deviation:

• QA verifies that all actions have been completed
   

• Effectiveness of the CAPA is assessed
   

• Closure is documented with signatures and a final impact statement
   

Deviations and CAPA records are retained as GMP documentation and reviewed during internal audits and regulatory inspections.

Conclusion

Our deviation handling process ensures timely detection, structured investigation,GMP Implementation in Kuwait and effective resolution of GMP issues. This strengthens our overall quality system, supports continuous improvement, and ensures consistent compliance with GMP standards.