Out of Specification (OOS) in Packaging Material

Standard Operating Procedure (SOP) for Handling of Out of Specification (OOS) test results in packaging (packing) material so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence.

Handling of Out of Specification (OOS) in Packaging Material

1.0   Purpose – SOP for OOS in Packaging Material

    • To describe the procedure for handling of out of specification (OOS) test results in Packaging material testing so as to ensure that all such test results are properly investigated and closed before taking a decision to release/reject the item, and corrective actions are taken to avoid recurrence.

Related: Handling of Out of Specification (OOS) Test Result

2.0   SCOPE – SOP for OOS in Packaging Material

    • This SOP shall be applicable for all out of specification results that are obtained for packaging material.
    • This SOP (SOP for OOS in Packaging Material) is not applicable to:OOS in Packing Material
      • Rejection of packaging material due to online unacceptability of Packaging material.
      • Miscellaneous items.
      • Results observed due to incomplete analysis (due to malfunction of equipment) where results are not derived.
      • Material rejected due to non-compliance of physical parameters like description, colour and text matter etc.

3.0   RESPONSIBILITY-SOP for OOS in Packaging Material

    • Officer / Executive, QC: To inform the OOS test result to the Supervisor or Head QC
    • QC Head :  To initiate the laboratory investigation on OOS test results and forwarding laboratory investigation report to Quality Assurance for final disposition, in case of real OOS test.
    • Head, Production/designee:  To initiate and supervise item performance evaluation
    • Head, QA / designee: To decide for final disposition of material.

4.0   DEFINITION (S) – SOP for OOS in Packaging Material

    • OOS:

    • An unacceptable result, that is the outcome of the analysis.
    • The result, which does not meet the pre-established specification of test material, is termed as OOS (Out of Specification) result.
    • Assignable cause:

    • A cause that has been identified as the reason to invalidate a questionable test result.
    • The assignable cause is a conclusion derived from direct or indirect evidence found during the investigation process, from the interpretation of analytical data or a combination of both.
    • Investigation:

    • An investigation jointly conducted by an investigator and the analyst.
    • The purpose of the analytical investigation is to verify that a valid result was obtained or discover what occurred to explain an invalid result.
    • It must be thorough enough to discover any analyst or equipment error, if one occurred.
    • Re-analysis:

    • Repeat the analysis by using one or more steps of the test method from the original sample.
    • A re-analysis may include the preparation of test reagents, etc. as appropriate.
    • Re-sampling: A fresh sample is withdrawn by repeating the sampling procedure for the material.
    • Average Value: Mean value of the results.
    • Analyst – 1: The principle analyst who is first to observe out of specification result.
    • Critical Defect:

    • A critical defect is a defect that judgment and experience indicate would result in hazardous or unsafe conditions for individual using, maintaining, or depending upon the product, or a defect that judgment and experience indicate is likely to prevent the performance of the strategic function of the dosage form (Acceptable Quality Level of 0.65)
    • Major Defect:

    • A major defect is a defect, other than critical that is likely to result in failure, or to reduce the usability of the unit of product/ material for its intended purpose (Acceptable Quality Level of 1.0)
    • Minor Defect:

    • A minor defect is a defect that is not likely to reduce the usability of the unit of product/ material for its intended purpose or is a departure from established standards having little bearing on the effective use of the unit. (Acceptable Quality Level of 4.0)

5.0   PROCEDURE – SOP for OOS in Packaging Material

    • Stage I- OOS investigation in Packaging Material

    • In case of out of specification test result, the analyst shall inform to immediate senior and shall retain all specimens for investigation.
    • The samples shall not be destroyed until its investigation is complete, where applicable.
    • Head QC or designee shall raise a requisition to QA for “Out of Specification Investigation for Packaging Material” (Annexure-I).
    • Quality Assurance shall issue a controlled copy of the form and record the details in “OOS Investigation for Packaging Material Issuance Register” (Annexure-II) to Head-QC or his designee.
    • Prior to issuance, a unique no. shall be allotted to the form (Investigation of OOS in Packaging Material).
    • All forms shall be numbered in the format OOSP/ YY /XXX, where
      • OOSP     – stands for Out of Specification (OOS) Form for Packaging Material
      • /              – stands for forwarding slash
      • YY            – stands for Current year e.g. 13 for 2013, 14 for 2014
      • /           – stands for forward slash
      • XXX     – stands for serial number starting from 001,002,003….etc.
    • (e.g.     – First form in the year 2020 shall be given form no. as OOSP/20/001).
    • Head QC or designee shall discuss with the analyst as the first investigation for the following but not limited to this:

      • Adequacy of analyst knowledge
      • Sample collection and preparation, as and where applicable
      • Sample storage
      • Use of correct test method
      • Confirmation of performance of instruments (any malfunction, if any during analysis)
      • Verification of calculation for its correctness
      • Record the findings based upon the preliminary investigation and discussion with analyst –1 in discussion point column of “Out of Specification Investigation in Packaging Material” Form followed by a summary of the investigation.
      • In case the cause of the error is identified, conduct re-analysis of sample specimen by analyst 1
      • If the sample passes, reject the previous results and pass the consignment

Note: In case the specimen is not available due to the destructive nature of the analysis, the next specimen for a sampled lot shall be taken for further investigation.

    • Stage II – SOP for OOS in Packaging Material

    • In case, the reason for out of specification is not identifiable (non-assignable cause of failure), the following steps shall be taken by Head QC.
    • The available specimen shall be retested by Analyst 2.
    • If the sample passes, Analyst 1 shall test a fresh specimen from the already sampled lot in triplicate and the results recorded.
    • If all three results of Analyst 1 pass, then take the mean of results reported by Analyst 2 and analyst 1 and report the results.
    • This shall be applicable for all tests that are quantitative in nature.
    • In the case of non-quantitative tests, three observations shall be recorded but mean shall not be applicable.
    • Invalidate the results of Analyst 1(OOS result) and release the consignment.
    • Stage III – SOP for OOS in Packaging Material

    • In case the cause cannot be identified and the initial result of analyst suggests failure, a fresh sample shall be withdrawn from the consignment after approval for the same from Head-QA.
    • The justification of same shall be provided by Head QC.
    • The sample quantity shall be decided by Head QC based on the nature of the test.
    • The sample shall be re-analysed by Analyst 1 and Analyst 2 or 3.
    • If all results pass, invalidate the OOS and approve the consignment.
    • For reporting the results, take the mean of six analysis (analyzed by above two analysts).
    • This shall be applicable for all tests that are quantitative in nature.
    • In the case of non-quantitative tests, three observations shall be recorded but mean shall not be applicable.
    • If all the results fail, acknowledge the OOS. A final conclusion shall be done by Head QC and shall then communicate to Head QA.
    • The decision shall be taken by Head QA Assurance for approval or rejection of the material.
    • In case cross-functional investigation is suggested by head QA, it shall be planned.
    • OOS on a parameter that does not impact machine performance or product quality or compliance to marketing authorization/ licence requirement, may be considered for cross-functional evaluation for use.

Note: Failure in critical parameters like the thickness of foil, wad thickness shall not be given conditional approval.

    • The use of consignment shall be through planned deviation.
    • QA shall send a communication to Corporate Quality Assurance regarding the vendor involved and the nature of the defect.
    • In case the consignment cannot be used, the same shall be rejected.
    • Head-QC or designee shall attach all pertinent records and raw data with the OOS form.
    • OOS form shall be given to Head Quality Assurance along with all the attachments / raw data for review.
    • OOS investigation shall be closed within 30 working days.
    • In the case of the unavoidable delay, the same shall be extended with proper justification and approval from Head-QA.
    • All rejected Packaging material shall be handled as per SOP (Handling of Rejected Raw and Packaging Material). Printed packaging material shall be destroyed on-site.
    • Note: In case of specific test like a failure in dimension or other similar which do not involve elaborate instrumental analysis and results can be judged based on experience or and appearance of the sample, the stage-wise investigation may be skipped and final conclusion may be given by Head QC and QA.

6.0   ABBREVIATION (S)

    • OOS:  Out of Specification

7.0   REFERENCE (S)

8.0   ANNEXURE (S)

    • Annexure – I: Out of Specification Investigation for Packaging Material.

Form No. : OOSP/ _ _ _ /_ _ Issued by (Sign / Date) :
Issued to (Name) : Date :

 

Item          :
AR No.     :
Test: Results: Limit:
Analyzed by: Date: Reference:
  • Details of Investigation (Out of Specification – OOS in Packaging Material)
Sr. No. Parameters Observation Sign / Date
1.       Confirm analyst knowledge
2.       Checked Condition of the sample. (Check for Physical examination, storage condition, labeling, etc.)
3.       Instrument Calibration checked. (Check as per respective SOP)
4.       Operation malfunction of the instrument during analysis, if any
5.       Checked for sample preparation is as per STP/ GTP
6.       Verification of calculation for its correctness
  • Discussion with the analyst (Out of Specification – OOS in Packaging Material)
Sr. No. Discussion point Remark of Investigator
Summary of the investigation by the investigator (Based on Raw data checking / Discussion/ Previous experience, additionally mention if the cause can be identified and assigned):
Sign: Date:
  •  Stage  I (Out of Specification – OOS in Packaging Material) –

Assignable Cause Found

Step 1: Approval  of Reanalysis

Reanalysis approval with the same sample / same specimen originally collected by analyst-1.

Allotted By/ Date: Allotted To/ Date (Analyst 1) :

 

Results: Limit:
Analyzed by (Analyst 1) : Date: Reference:

 

Conclusion of stage I:
Head QC  (Sign / Date):
  •  Stage  II – (Out of Specification – OOS in Packaging Material)

 No Assignable Cause Found

Step 1: Reanalysis approval with same sample / same specimen originally collected by analyst-1 to be  analyzed by Analyst-2
Allotted By / Date: Allotted To/ Date:
Result (A) by Analyst 2
Analyzed by: Date: Limit:
The remark of the investigator:

The sample complies / not complies to limit. If no move to step 2

Sign:                Date:

 

Step 2 : Analysis of fresh specimen of the original sample by Analyst –1 in triplicate
Allotted By/ Date: Allotted To/ Date:
Result (B) Analyzed by/ Date Limit

1

2

3

Mean of 3 analysis, if applicable :
Average of all individual results of A and B, if applicable :
The remark of the investigator:

The sample complies / not complies to limit.

Sign:                Date:
Conclusion of stage- II (rejected/ approval for re sampling/ cross functional investigation)
Head QC:                                                                       Date     :
  • Step III – (Out of Specification – OOS in Packaging Material)

Material Resampling Authorization

Justification for Resampling  by Head-QC

Head, QC (Sign and date)

Authorization of Resampling by Head, QA

Head, QA (Sign and date)

Instructions for sampling:

  • In case of re-sampling, follow the respective SOP
  • Quantity of sampling shall be based on the test required.
AR No. Quantity Sampled By/Date

 Re-analysis of the re-sample specimen by Analyst –1 and analyst 2 (or analyst 3) in triplicate

Allotted By / Date: Allotted To / Date:
Result (A) by Analyst –1 Analyzed by/ Date Limit

1

2

3

Average of 3 analysis, if applicable: …………………

 

Result (B) by Analyst – 2 (or analyst –3) Analyzed by/ Date Limit

1

2

3

Average of 3 analysis, if applicable: …………………
Average of all individual results of Analysis, if applicable:
Remark s by Investigator:
Sign: Date:

 

Final Conclusion by Head, Quality and Head, Quality Assurance

Head, QC  (Sign / Date):
Head, QA  (Sign / Date):

 Cross-functional investigation – Review by QA and Production

Comments by Production : _____________________________________

Done By (Sign / Date)                                                               Reviewed By (Sign / Date)

Quality Assurance : _____________________________________

Done By (Sign / Date)                                                               Reviewed By (Sign / Date)

The material may be used/ rejected____________________________
            Plant Head Head QC Head QA
Sign & Date      
Final Conclusion: 

Head, QA (Sign/ Date) :

(in case the material is to be used, production shall raise a deviation )

    • Annexure-II: Out of Specification Investigation for Packaging Material Issuance Register

Sr.No.

Item A.R. No. Test Form No. Issuance Details Completion details

Remark

Issued By Received By Action Taken Date

 

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pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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