SOP for Out Of Calibration in Pharma | SOP for Calibration failure | Out Of Calibration as per 21CFR & ISO Guidelines |
- OOC SOP covers below points:
- Calibration definition
- Out of Calibration definition
- Out of Calibration procedure
- Calibration schedule
1.0 OBJECTIVE :
- To lay down a procedure for investigating and handling of Out of Calibration (OOC) of measuring device/Instruments.
2.0 SCOPE :
- This SOP is applicable to Out of Calibration of measuring device or instruments which are used for testing of Raw material, Packaging material, Finished Product and Stability samples in Quality Control Department.
3.0 RESPONSIBILITY :
- Analyst :
- To perform calibration and report the calibration status.
- Section Head :
- To co-ordinate with Head-QC regarding OOC results and participate in investigation for the same.
- Head QC:
- To ensure that this SOP is followed during investigation of OOC results.
- To investigate Out of Calibration.
- Head QA :
- To Investigate Out of Calibration and approval.
- Quality Control Head and Quality Assurance Head
5.0 PROCEDURE :
Definition: Calibration is a set of operation that establish, under specified condition, the relationship between values of quantities indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standards.
It is the setting or correcting or adjusting of a measuring device or base level, to match or conform to a known and unvarying measure.
5.1 The calibration of instrument is a critical activity and it is carried out to ensure the performance and suitability of the instruments.
5.2 The calibration of instruments, apparatus, gauges and recording devises at suitable intervals in accordance with an established written program containing specific direction, schedules, limits for accuracy and precision and provision for remedial action in the event accuracy and /or precision limit are not met.
5.3 Instruments, apparatus, gauges and recording devices not meeting established specification shall not be used.
5.4 The procedure of calibration of each instrument is mentioned in SOP of respective instrument.
5.5 The frequency of each instrument is ± 5 days of defined interval, mentioned in respective SOP.
5.6 The schedule for calibration is prepared at the beginning of the year as per the Annexure No. 01.
5.7 The calibration schedule is checked by QC Head and approved by QA Head.
5.8 OUT OF CALIBRATION (OOC): It is defined as a failure to meet the acceptance criteria during the calibration.
- If out of calibration results found, affix a status label “OUT OF CALIBRATION” immediately. The failure in meeting the limits during the calibration (OOC) shall be thoroughly investigated to find the root cause, its impacts and for taking corrective and preventive action to avoid recurrence of such an incidence.
- Since the result is out of calibration, it needs to be checked for analyst / instrument error quickly for further decision making process, as below.
- Analyst error:
- Check competency of analyst by verifying analyst qualification, training, knowledge and experience, expertise in calibration, any objectionable issue, recording and reporting and behavioural pattern.
- Instrument error:
- Verify earlier calibration/ qualification record, previous instrument history, cleanliness, chocking/ blocking of material, preventive engineering status, physical condition.
- Check standards/ chemicals used for calibration and its validity, Glassware and instrument consumables spares.
- Check SOP for operation and calibration of instrument and it’s format, environment conditions (temperature /humidity), dilution of solution (concentration), relevancy of methodology, calibration frequency, calibration limit too stringent etc.
- Analyst error:
- Rectify and repeat the calibration, if an error is observed in investigation, after approval from quality assurance.
- It will be documented properly and appropriate corrective and preventive action will be taken.
- If no error is found, the instrument is required to be checked and serviced as follow;
- Inform the Engineering Department to carry out in-house rectification of the instrument.
- If the in-house Engineering Department can rectify the defect, then use the instrument after proper calibration.
- In case in-house Engineering Department is unable to rectify the defect, call the service engineer of the instrument.
- Once the said instrument is repaired by a small correction or major part replacements based on the recommendation of service engineer, then carry out calibration and ensure that it is working satisfactorily.
- If the external expert performs the servicing satisfactorily, use the instrument after calibration for routine analysis.
- If the external expert fails to rectify the instrument, affix a status label “OUT OF ORDER”.
- Arrange to replace the instrument for analysis, if available in lab or send the sample to approved external laboratory for testing.
- If required, based on the recommendations and our assessment, instrument may be discontinued with proper documentation.
- If no error is found in investigation related with instrument, analyst, used materials and process, product related investigation is started.
- It is not possible to judge, the exact date from the instrument was not suitable. The following points are necessary for the product related investigation.
- List out the number of samples tested on the suspected instrument.
- List out number of samples approved in recent past.
- List out number of samples rejected in recent past.
- Review of trend of analyzed product for confirming OOC period.
- Check testing methodology and relevancy of testing methodology.
- Verify the details of instruments used.
- Check analytical data including system suitability/ instrument verification before start up of analysis.
- All products tested on suspected instrument are kept on “HOLD”, since earlier successful calibration and labeled appropriately.
- If OOC period is identified, all products are re-tested on urgent basis on similar other instrument or alternate instrument or outside laboratory whatever feasible.
- If OOC period is not identified, last ten batches are selected for re-testing based on criticality of the test and analyzed on urgent basis.
- If the re-testing results are found satisfactory, it shows that it is not impacted on the product quality. An effective risk assessment is carried out for efficacy and quality of drug product and safety for patient.
- If any abnormality is observed in re-testing results, the batch/ batches will be recalled from market as per recall procedure (Product Recall SOP).
- Available products shall be reprocessed / reworked after appropriate approvals and documentation procedure.
- The instrument calibration frequencies shall be kept in such a way that the situation must be under control in any incidences happening with respect to operation, calibration and engineering procedures.
- The analyst, who is responsible for calibration and related activities, should be well trained and experienced for operation and calibration of instrument.
|Out Of Calibration
|Standard Operating Procedure
|Label for Out of Calibration
|Label for Out of Order
8.0 SOP REFERENCES
- 21CFR 211.160 (Laboratory Controls).
- ISO 13485 & ISO 9001, Clause 7.6, Control of monitoring and measuring devices.
END OF THE SOP
Annex. No. 01 Calibration Schedule
Annex. No. 02 Label for Out of Calibration
Annex. No. 03 Label for Out of Order