Types of GMP Observations
- Critical Observation: Potential risk harm to the user
- Major Observation: Major deviation from GMP
- Minor or Other Observation: Departure from good practice
Common Deficiencies
1. Quality Assurance System
2. Qualification and Validation
3. Premises
4. Personnel
5. Equipments
6. Sampling and Dispensing
7. Materials
8. Quality Control
9. Heating, Ventilation and Air Conditioning (HVAC)
10. Environmental Monitoring Programme
1. QUALITY ASSURANCE SYSTEM
- SOP’s and other procedures are not complete/informative, unclear and provide the required information.
- Senior staff of the quality control laboratory and production departments was not able to explain the SOP.
- Poor recall procedures.
- No risk assessment was performed in order to identify critical process steps and parameters requiring validation.
- No justification for in house specifications provided.
- Inappropriate handling Out-of-Specification results.
- Deviations from established procedure or standard are not documented, explained or investigated.
2. QUALIFICATION AND VALIDATION
- No, incomplete or inappropriate qualification and validation for:
- System
- Methods
- Process
- Cleaning
- Equipments
- Personnel
- Software
- Equipment, systems and processes that require qualification and validation have not been identified and policies not defined.
- Inadequate qualification of Equipment, Water system, HVAC system etc.
3. PREMISES
- No segregation existed between the manufacturing area in which beta-lactam were handled and the manufacturing areas in which non-beta-lactam products were handled.
- No systems for dust control existed in dispensing rooms.
- Drainages in production areas had no sanitary design.
- Drainages were found with stagnant water opening directly into production area.
- Areas for the dispensing and manufacture of non-sterile products were maintained at ambient pressure.
- The surface finish of walls and ceiling was not smooth and hence did not allow for effective cleaning.
- The epoxy coating was found damaged and hence not ensuring smooth flooring.
- Production areas were found opening directly to outside environment
- Effluents were not treated by the company but discharged directly into the general sewage system of the area.
- No airlocks were installed separating areas required to be clean areas from general, uncontrolled areas.
4. PERSONNEL
- Newly recruited staff not getting adequate induction GMP training and specialized training.
- On-job refreshment training is insuffient.
- Inadequate basic training: basics of GMP, Hygiene & Sanitation, Safety, entry/exit procedures.
- No evaluation of in-service training: Operating instruction of production machines, Job related Training (SOPs Training), maintenance of BMRs and GLP training.
- Inadequate Personnel hygiene procedures and facilities.
5. EQUIPMENT
- Poor documentation (URS, Specifications)
- No or inadequate qualification
- No planned preventive maintenance programme.
- No cleaning procedures or not adequately validated or executed.
- The maximum holding time of dirty equipment before cleaning was not defined.
- The qualification status of equipment and utilities was not defined.
6. MATERIALS
- Raw materials being not Pharmaceutical grade were used for pharmaceutical manufacturing.
- Materials were found not being labeled with their manufacturing stages.
- The sampling plan did not define sampling methods, labeling and storage of samples.
- Standards were not assigned expiry dates after opening.
7. SAMPLING AND DISPENSING
- No zone concept existed for the sampling area.
- No material airlock existed for the sampling area.
- No procedure for handling of spillages existed in the sampling and dispensing.
8. QUALITY CONTROL
- Contradicting data were observed in worksheet and workbook.
- There is no defined procedures how samples are coming from production and warehouse for testing.
- Detail of material and equipments used during the test was not recorded.
- Calculations of values were made by hand and formulas were not validated.
- Test samples in the stability chamber was stored so congested that can alter the free flow of air that can compromise on the validity of the test result.
- No samples are retained or in appropriately stored
9. HEATING, VENTILATION AND AIR CONDITIONING (HVAC)
- Specifications of primary and secondary filters were unknown.
- Pressure drops over primary and secondary filters were not monitored.
- No preventive maintenance existed for the air handling system.
- No schedule for filter cleaning existed.
- Air flow directions were not indicated.
10. ENVIRONMENTAL MONITORING
- No action and alert limits were defined for particle counts and microbial load.
- Routine monitoring of micro-organisms and particle counts was done using a reduced number of sampling positions.
- No annual environmental monitoring reports were prepared.
- No environmental monitoring was performed in areas for manufacture of non-sterile products.
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