Handling of deviation
Deviation:Aviation are measured difference between observed value and expected or normal value for a process or product condition.
Why deviation occurs:
GMP Mistakes or Error
- Performing an activity without proper training.
- Failure due to not following written SOPs,STP or approved batch record instruction.
- Reprocessing or rework.
- Unapproved changes.
- Planned deviation
- Unplanned deviation
- Planned deviation, which are described, and pre approved deviation from the current operational document/system, covering a specified period of time or number of batches.
- All changes should be evaluated for quality of product and yield of products.
- The need for qualification or re-validation.
- Change ultimately approved are rejected by quality assurance.
- For quality improvement of products.
- Use new instrument or new method parameter.
- Maintenance as per schedule.
- Break down/Shut down as per schedule.
- For yield improvement of products.
- Celebration or validation is not carried out of any instrument or equipment as per schedule due to delay for various reasons.
- Change in batch size of any product.
- Product release without complete results of quality control.
Any uncontrolled event in the form of the designed system or procedure at any stage of manufacturing, packaging, testing, holding and storage of drugs. It is defined as unplanned deviation. For example:
- SOP & STP not fallow up.
- Yield less or more against standard yield.
- Expired standard and chemical use.
- Not calibrated instrument use.
- Instrument break down during analysis.
- Any failure of utility (HVAC,Heating, ventilation, and air conditioning)
- Any failure of parameter (fluctuations in Humidity or Temperature)
- Any failure of equipment (sudden break down)
Category of deviation:
- When cGMP has a significant effect and above quality also has a significant effect, it is placed in the category of critical deviation. OR
- It is also considered to be a critical deviation when there is a minor impact above the cGMP and a significant impact above the quality.
- Such deviation requiring immediate action, investigation and documentation as such by the appropriate SOP
- Expired are rejected chemical/Reagents/Standards used.
- Cross contamination in product.
- When cGMP has a significant effect and quality has a miner effect, it is placed in the category of major deviation.
- Such deviation requiring immediate action, investigation and documentation as such by the appropriate SOP.
- Use of unapproved reference/working standard.
- Finished product analysis done on not calibrated instrument.
- Production started without line clearance.
- Filter integrity test not performed.
- Operational parameter out if range.
- When cGMP has a miner effect and above quality also has a miner effect, it is placed in the category of miner deviation.
- Such deviations treated as such by the applicable procedure.
- Skip of FIFO (First in first out) principal.
- Instrument break down during idle condition.
- Labeling of instrument not done as per SOP.