procedure for example of preparetion of oos trend in pharmaceutial labs.

Trend Analysis of Out of Specification Results


Sr. No. Description
  1 Objective
  2 Scope
  3 Responsibility
  4 Procedure
  5 Review and Conclusion
  6 Way Forward Recommendation
  7 Training
  1. Objective:

The purpose of this document is to analyze the trend of the OOS occurring at quality control laboratory of the site. This trend analysis helps to evaluate the area of concerns and to implement the remedial actions accordingly.

  • Scope:

The scope of this document is applicable to the QC labs .

  • Responsibility:
    • Quality Control:
      • Perform the trending of OOS based upon the assigned probable root cause and identify the area of concerns.
      • Review the trending and the data compilation.
      • Initiate suitable Corrective and Preventive actions as per the evaluation of the trend.
    • Quality Assurance Head:
      • Review and approve the trend report, proposed CAPA as per identified area of concerns.
      • Ensure the CAPA effectiveness.
      • Responsible for CAPA implementation and effectiveness.
      • Evaluation of gaps and the identified remediation.
  • Procedure:

The subjected OOS is listed down and the trend analysis is performed based upon following categories:

  • Total No. of OOS in year:
Month No. of OOS
Jan 2
Feb 1
Mar 1
Total 4


In the year there are total 4 OOS are obtained since March. Out of these 4 OOS, maximum 2 OOS are obtained in the month of January. In the February & March there is one OOS is obtained per month.

  1. OOS BREAK UP-Confirmed/Invalidated OOS:
Month Confirmed Invalidated
Jan 0 2
Feb 0 1
Mar 0 1
Total 0 4


Out of 4 OOS there are 4 OOS deemed as invalid and no OOS are confirmed. The 1st invalid OOS is obtained in the product of XYZ and 2nd is in the product of XYZ in the month of January. 3rd invalid OOS obtained in the product of XYZ in the month of February and 4th invalid OOS obtained in the product of XYZ in the month of March.

  1. Section wise (RM/Stability/Finished Product/Micro/PM):
Section Wise No. of OOS
RM 0
Stability 1
Finish Product 3
Micro 0
PM 0
Total 4


In the quality control department there are 5 separate sections i.e. Raw Material (RM), Stability, Finish Product, Micro & Packing Material (PM). There is 1 OOS observed in Stability section, 3 observed in finish section and none OOS observed in RM section, PM section and micro section. Maximum OOS observed in finish section.

  1. Product wise:
Product No. of OOS
Lerzin M 1
Total 4


The observed OOS is obtained in different product. There are no repeated OOS is observed in a same / similar product.

  1. Test wise:
Test wise No of OOS
Assay 2
Dissolution 1
Uniformity of content 1
Total 4


Based on the total OOS observed, there are 2 OOS observed in assay test, 1 in dissolution test and 1 in Uniformity of content test. Maximum OOS are observed in assay test.

  1. Root cause, category wise (personnel error/Instrument error/Analytical Method error / Sampling error materials/ Document/ Storage error/ Non-Assignable / Manufacturing/Process/Other etc.)
Category Wise No of OOS
Personnel error 4
Instrument error 0
Column error 0
Analytical method error 0
Sampling error 0
Product error 0
Total 4


On the basis of investigation the root cause are identified and out of these identified root cause, there are all 4 OOS is occurred due to personnel error.

  1. Analytical error wise (Dilution error/Pipette error/Weigh error/Procedural error etc.)
Analytical error wise No of OOS
Diluent error 1
STP not followed 0
Sample storage error 0
Contamination 0
Sample preparation error 2
Column error 1
Total 4


From the above graphical representation of analytical error it is classified into dilution error, Standard testing procedure not followed, sample storage error, contamination, sample preparation error and column related error. Out of these all ‘Sample preparation error’ is repeated laboratory analytical error and it is occurred by different analyst and in different product.

  1. Instrument error wise (Instrument type/Instrument ID wise)

Classification of instrument error: NA

  • Review and conclusion:

Based on the review of OOS trending of year the subjected total OOS are 4 nos. and all OOS are occurred in respective department of finish and stability section. All OOS are investigated as per OOS standard procedure and effective CAPA is implemented. Out of 4 OOS, all 4 OOS are invalidated. These 4 OOS are obtained from personnel error (laboratory).. From this it is concluded that the maximum OOS are occurred due to personal error. Based on the personnel error (laboratory) training shall be imparted to concern user on training module. These OOS do not have any impact on the product quality and system.

  • Way Forward Recommendation:

To prevent these OOS training shall be imparted to all users. After given awareness on identified personnel error.

  • Training: Training to be provided as per recommendation.

This training session to be provided all users.

Prepared By:                                        Checked By:                          Approved By:

Sign/Date                                              Sign/Date                               Sign/Date

Bhanu Pratap Singh


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