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OOT Investigation Form

 

Date of OOT occurrence:

OOT Reference No.:

A] OOT REPORTING: (To be completed by the analyst)

Product / Material Name

 

QC Reference No.

 

Batch No.

 

Mfg. Date

 

Specification No.

 

Expiry Date

 

Test Name

 

Test Method No.

 

 

Stage of testing

 

(For Drug substance / Intermediate / Drug product)

(select the applicable option)

 

In-process

 

Finished product / Intermediate release testing

 

Stability              Months Accelerated / Long Term / Intermediate

Summary of OOT Test Results (state result and specification)

 

Details of abnormal observations noted during the testing, if any

 

 

Analyst Name

 

Signature & Date

 

 

 

OOT Reference No.:

B] LABORATORY INVESTIGATION:


Sr.

No.

Check Parameters

Observations (Yes/No/NA)

Comments

1.0

Sampling

 

 

1.1

Any abnormal observation noted during sampling?

 

 

1.2

Any noticeable difference in sample appearance?

 

 

1.3

Sample is correctly collected & labeled?

 

 

1.4

Sample storage was done appropriately?

 

 

2.0

General

 

 

2.1

Any unusual happening in lab? (e.g. power failure)

 

 

2.2

Was the method discussed with the analyst?

 

 

2.3

Correct analytical method used?

 

 

2.4

Analyst was trained to perform the test?

 

 

2.5

Correct glassware used for dilutions?

 

 

2.6

Glassware were properly cleaned?

 

 

2.7

Instrument used are qualified?

 

 

 

 

 

2.8

Instruments used within calibration validity period

 

Instrument Used (Name & Id)

Calibration Due

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2.9

Instrument setup & operation as per standard operating procedure?

 

 

2.10

Use of appropriate grade of chemical and reagents within the

validity period?

 

 

2.11

Correct normality / molarity of volumetric solutions used?

 

 

 

 

2.12

VS used

Valid up to date

Strength

 

 

 

 

 

 

 

 

 

 

 

 


OOT Reference No.:

Sr.

No.

Check Parameters

Observations (Yes/No/NA)

Comments

3.0

Sample / Standards Preparation

3.1

Sample & Std preparations done as per the test method?

 

 

3.2

Is any weighing error identified?

 

 

3.3

Correct potency of standard used in calculation? Standard is within validity period?

 

 

 

 

 

3.4

Std(s) Used

Valid up to date

Potency

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3.5

Is the sample properly shaken, sonicated or heated / warmed as per method of analysis?

 

 

3.6

Are the sample / standard dilutions correctly performed as per

method of analysis?

 

 

3.7

Any noticeable preparation? Difference noted in the sample/Standard

 

 

 

3.8

Are the samples filtered/ centrifuged / membrane filtered properly before introduction into the instrument or analysis by classical method?

 

 

3.9

Are samples/standards preparations stored under correct environment/time before analysis?

 

 

3.10

Tablets / granules are ground properly?

 

 

3.11

Any errors in calculation and transcription?

 

 

4.0

Chromatography

 

4.1

Correct Column Used (E.g. column make, Dimension, Particle Size, End capped / Non-End capped, Pore Size, Carbon Loading)?

 

 

4.2

Any leakages observed in the fittings?

 

 

 

4.3

Correct instrument parameters used (e.g. for HPLC – type of detector, flow rate, oven temp., wavelength, injection volume, sample temp. For GC type of detector, flow rate, oven temp. Injection volume, Inj. Temp, detector temp.)?

 

 

4.4

Mobile phase preparation is as per the method (check for composition, pH, air bubbles)?

 

 

4.5

Any unusual or unexpected response observed with standard or test preparations?

 

 

4.6

System suitability acceptance criteria were met during the

analysis?

 

 

 

 

OOT Reference No.:

Sr.

No.

Check Parameters

Observations (Yes/No/NA)

Comments

5.0

Dissolution

5.1

Correct instrument parameters used (apparatus type, speed, bath temperature, time, medium used, volume)?

 

 

5.2

Dissolution Medium Degassed?

 

 

5.3

Sample Withdrawn Correctly?

 

 

5.4

Correct Filter Used?

 

 

6.0

Microbiological Assay

(Note: Relevant points stated under Sr. nos. 1, 2 & 3 shall also be checked, as applicable)

6.1

Was media from single prepared lot used in the assay?

 

 

6.2

Was there any malfunction or breakdown of incubator?

 

 

6.3

Was temperature of incubator during incubation period as per requirement?

 

 

6.4

Are the zones of inhibition / exhibition clearly defined?

 

 

6.5

Is merging of zones seen?

 

 

6.6

Was zone reading done as per SOP?

 

 

6.7

Is the Zone reader / vernier calipers in calibrated state?

 

 

 

Instrument ID: Calibration due date:

 

 

7.0

Stability

7.1

Any malfunction or breakdown of stability chamber?

 

 

7.2

Any failure of utilities (power, water, UPS)?

 

 

7.3

Any deviation in temperature / humidity monitoring?

 

 

7.4

Any damage to pack?

 

 

7.5

Any deviation from SOP for sample pull out time?

 

 

7.6

Were samples, after pull out, stored as per the conditions specified in the SOP?

 

 

7.7

Were samples analysed within the specified time period as in the SOP?

 

 

7.8

Any change in method of analysis or specification?

 

 

7.9

Any other (to be specified)

 

 

 

 

OOT Reference No.:

8.0

Any other findings (review of method validation data, Trend data etc.):

 

 

9.0

Was similar OOT reported for this product earlier?

If yes, state the identified cause and corrective / preventive actions taken that time

10.0

LABORATORY ERROR IDENTIFIED : Yes / No

If yes, describe the error:

 

 

QC Analyst (Sign & Date)

 

 

Section In-charge of QC (Sign & Date)

11.0

ACTION TO BE FOLLOWED ( In case of lab error)

Yes/No

Comment

11.1

Retesting of retained sample solution by Original

Analyst

 

 

11.2

Retesting of retained sample by Original Analyst

 

 

11.3

Correction in document

 

 

11.4

Any other (To be specified)

 

 

 

 

Section In-charge Of QC (Sign & Date):

 

OOT Reference No.:

12.0

ACTION TO BE FOLLOWED (In case of obvious error related to sampling or sample handling)

REASON FOR RE-SAMPLING:

RE-SAMPLING PLAN:

Total number of containers

 

Number of containers to be sampled

 

Sample quantity from each container

 

Remarks or Special instructions:

 

 

QC In-charge (Sign & date)

 

 

QA In-charge (Sign & date)

13.0

RESULT OF RETEST (in case of obvious lab / sampling error):

1.

2.

 

 

Average =

 

 

QC Analyst (Sign & Date)

 

 

QC In-charge (Sign & Date)

CONCLUSION: OOT test result            Valid, Report the initial result

Invalid, Report new results

If OOT is valid, Initiation of Manufacturing Investigation

 

QA In-charge:

(Sign & Date)

C]

MANUFACTURING INVESTIGATION:

For details, refer to Annexure 4 - Manufacturing Investigation Form.

 

Manufacturing Error detected: Yes / No

 

 

 

Production In-charge (Sign & Date)

 

 

 

QA In-charge (Sign & Date)

 

QA decision on disposition of the batch:

 

 

 

 

 

QA In-charge (Sign & Date)


OOT Reference No.:

D]

CLOSURE OF OOT INVESTIGATION

 

Summary and Conclusion:

(Based on report of Laboratory / Manufacturing investigations)

 

 

 

 

 

 

 

 

 

 

Assignable Cause:

 

 

 

 

 

 

Corrective Action and Preventive Action:

 

 

 

 

 

 

 

If CAPA not completed within 30 days, CAPA ref. no.

 

 

 

QC In-charge (Sign & Date)

 

 

 

Production In-charge (Sign & Date)

 

 

 

QA In-charge (Sign & Date)

 

List of Attachments (if any):

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