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23-08-19 Investigation Report For OOS

The document details an investigation into out-of-specification assay test results for a metformin HCl tablet batch, which was found to contain 19.39% of the active ingredient instead of the specified 90-110%. The investigation determined that the initial sample analyzed was not actually from the metformin batch, but was instead a mixed-up sample from another product, likely due to the quality control laboratory's practice of storing different product samples together in common trays without adequate labeling or separation. Corrective and preventative actions will be implemented to address the sample mix-up issue.

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2K views

23-08-19 Investigation Report For OOS

The document details an investigation into out-of-specification assay test results for a metformin HCl tablet batch, which was found to contain 19.39% of the active ingredient instead of the specified 90-110%. The investigation determined that the initial sample analyzed was not actually from the metformin batch, but was instead a mixed-up sample from another product, likely due to the quality control laboratory's practice of storing different product samples together in common trays without adequate labeling or separation. Corrective and preventative actions will be implemented to address the sample mix-up issue.

Uploaded by

Deepak
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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PINNACLE LIFE SCIENCE PVT. LTD.

Khasra No. 1328-1330, Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 174101

CROSS FUNCTIONAL INVESTIGATION FOR Out of Specifications RESULTS


Reference OOS No. : PLS/OOS/19/07/001 Date: 26-07-19
OOS Details :- OOS results observed in Assay test parameters in Lubricated Granules (Blend samples) of
Metformin HCl Tablets IP 500mg. Observed OOS results are as follows : -
Brand Mfg. Exp. Batch Assay
Generic Name Batch No.
Name Date Date Size (Spec. 90.0 -110.0%)
Metformin HCl Tablets IP 500mg Metco AT-056519 07/2019 06/2021 6.66 Lac 19.39%

Investigation : the investigation started with the laboratory scale investigation. During laboratory scale investigation
following proceedings carried out :
- The sample received on 26-07-19 for blend uniformity analysis.
-the sample was allotted to Mr. Ansoo for analysis.
- on initial investigation, the analyst is questioned regarding the procedure followed by him during analysis. The concerned
analyst detailed the activity in detailed steps. But on sample checking, it is observed that the remaining part of the sample was
in black colored self sealing polybag with label as Metco. However as per standard practice, the samples are collected in clear
self sealing polybag & then further kept in self sealing black polybag with label.
- with the above observation in the remaining sample, the investigation is carried out further & data collected during
investigation is as follows:-
- The sample failing in assay specification, was manufactured at 1 st floor production block. On document verification, it is
observed that the previous product of the processing area was Aartrogyl-200 & the sample of the previous product was also
sent for blend analysis. The logs of QC Department reveals that both of the products samples were present in the Sample
holding tray simultaneously.
- On initial investigation, considering analyst error during preparation & pipette, the retesting of same sample, retesting of
fresh preparation is carried out & the results found OOS as earlier. Thus it is decided by Quality Unit to re-sample the blend
available in production. Meanwhile investigation in QC kept continuation for any possible discrepancy.
- The blend re-sampling done & sample analysed in QC & results found well within specifications. The passing results of
resampled blend confirmed that the sample which was analysed earlier as Metco is suspected.
- Based on the resampled blend results, site Quality unit directed the investigation for identification of the initial sample. The
initial sample is analysed as full scan identification in comparison with standard. The outcomes of full scan confirmed that the
initial sample is not Metco.
- The QC record review reveals that the sample of Artrogyl-200 & Nortini were available along with the metco samples in the
sample tray. Thus the identification of initial sample is proceeded along with the consideration of possible contamination or
mixing or interchange of samples. On sampling process review, it is noticed that the sampling is done in clear transparent self-
sealing polybag & the same sample bag is kept in self-sealing black polybag with label. However the label is present on outer
polybag only, which enhances the chances of sample interchange during receipt, handling & storage in QC.
- Identification of the initial sample is carried out by TLC by considering Artrogyl-200 & Nortini. The TLC analysis revealed
that the initial sample is +ve for Norfloxacin.
- On review of QC sample receipt & handling practice & procedure, it is observed that the samples submitted by IPQA & kept
in sample storage HDPE tray in QC laboratory. All the samples found kept in common tray.
PROBABLE ROOS CAUSE
Based on the above investigation it is confirmed that the OOS resulted due to sample interchange, which may be probably
during receipt, storage and handling in QC as there is no adequate receipt and storage arrangements for samples.. Common
tray to keep the samples which are to be allocated for analysis. Moreover the labeling practice is to fix the labels on outer
pack only also increase the possibility of interchange of samples.
CAPA

Conclusion:
Form No. QC-073/F2-00 Page 1 of 2
PINNACLE LIFE SCIENCE PVT. LTD.
Khasra No. 1328-1330, Village Manpura, Tehsil Baddi, Distt. Solan (H.P) 174101

CROSS FUNCTIONAL INVESTIGATION FOR Out of Specifications RESULTS

Particulars Investigated By Approved By


Sign/Date
Name
Designation QA QC Production GM Operations QA Head

Form No. QC-073/F2-00 Page 2 of 2

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