Page 1 of 5

PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

Attachment-II

Investigation Report
Reference Deviation No.:DV/20/003
Date: 27/10/2020

Detail of Observation

Working standard of mineral Oil was not qualified and used for testing of product Oilatum Bar and
Oilatum Kids Bar.

Investigation Team
S.No. Name of Person Department & Designation Role
1 Mr. S.P. Singh Manager Quality Control Lead Investigator
2 Mr. Ajay Singh Asst Manager, Quality Assurance Investigator

Detail of Investigation
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PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

Attachment-II

Investigation Report
Reference Deviation No.:DV/20/003
Date: 27/10/2020

In view of said observation the following details area are review to find out the root cause of observed
deviation.
1-Review the STS and STP for raw material.
2- Review the USP Monograph
3-Review the Supplier COA
4- Review of STS and STP of Finish Products
5- Working standard qualification procedure.

1-Review of STS and STP of Raw Material: During review of STP its found that no working
standard required to test the raw material Mineral Oil USP and STP does not state to calculate the
potency of Material Oil hence no need of working standard required to analyzed the raw material.
Further extended the investigation review the raw material USP monograph.

2-Review the USP Monograph: Review the Mineral Oil USP monograph for raw material testing
and there is no test procedure define to calculate the potency calculation of the raw material and
Other USP test parameter complies in existing STS and STP of raw material hence extended the
investigation with discussion of manufacturer.

3-Review of Supplier COA (Mineral Oil USP) : Raw Material Mineral Oil supplied by Savita Oil
and review the manufacturer COA and it is observed that Raw material tested as per USP. There is
No test procedure define for potency calculation in mineral Oil hence manufactured does not provide
potency.

4- Review of STS and STP of Finish Products : STS and STP of Oilatum Bar and Oilatum Kids
Bar reviewed and test procedure define the potency calculation for Mineral Oil due to Label Claim
mention of Product Pack as-
Mineral Oil 7.5%
To quantify the % qty of finish product, potency calculation has been done for each batch using the
raw material (Mineral Oil USP) as a working standard with considering the potency 100%. Working
standard provided the validity 6 Month.

5-Working standard qualification procedure: Working standard SOP reviewed and procedure
stated for validity of working standard is 06 month and verified all available working standard
qualified against the reference standard. Since in this case due to non availablibility of Reference
standard Raw material treat as working standard with considering the potency 100% and used for
testing of finish product to calculate the % qty.

Also check the available literature it is identified that Mineral oil are the fractions of hydrocarbons
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PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

Attachment-II

Investigation Report
Reference Deviation No.:DV/20/003
Date: 27/10/2020

naturally occurring in crude petroleum & collected during purification. It’s composition always vary
because of varying proportions of various hydrocarbons in this mixture. Therefore pharmacopeia
differentiate on the basis of weight/ml & viscosity only to light/heavy liquid paraffin & assay test is
also not mentioned. In the same way USP reference available for qualitative use. Using the USP
reference we can’t establish WS through comparison as mass & NMR both will vary because of
presence of different ratio of hydrocarbon fractions.

Further this issue has been discuss with customer and they have suggested that following to be
reviewed-
1. Analysis to be performed using current Mineral oil RM as WS and same lot of mineral oil
added in the batch.
2. Mineral Oil WS retest frequency 6 M require documented evidences.

Based On above comments further investigation extended and analysis to be perform and data
generated to identify the gap below data has been generated using the same lot of raw material as
WS added in batch.

Comparative study has been performed on dated 18/12/2020.

Product Batch No Batch No of Raw Assay Assay using the same Working
Name Material used in (WS in lot of raw material standard
manufacturing used ) used in manufacturing details
of product of product
Oilatum Bar BSP1642 0000045498 100.74 99.03 Mfg:29/1
0/2020
Use
Before:28
/04/2021
Conclusion: Comparison of test results for both working standard and material used in batch
manufacturing treated as working standard and test results indicate that within the analytical
variation.

 Comparison study of Naphthalene AR and Napthalene RS done and comparision details as-
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PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

Attachment-II

Investigation Report
Reference Deviation No.:DV/20/003
Date: 27/10/2020

Comparison Naphthalene AR Naphthalene RS

Parameter
Molecular Weight 128.17 128.17

Molecular Formula C10H8 C10H8

Chemical Structure

CAS No 91-20-3 91-20-3

Conclusion: On basis of comparative study of Napthalene AR and Napthalene RS both are similar in
molecular weight, formula and chemical structure. However to comply the USP requirement
Napthalene RS shall be used to test the Limit of Polymorphic test define in Raw Material
Specification.

Probable Root Cause

Due to unavailability of reference standard and Potency calculation not official in any pharmacopeia.

Impact Assessment
Refer Attachment I.

CAPA
Corrective Action-
1. STP to be updated to define the same lot of raw material used for testing of finish products.
2. Stability Data to be generated up to define the shelf life 6M.
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PSYCHOTROPICS INDIA LIMITED

Plot No-46 & 49, Sector-6A,I.I.E.,SIDCUL,Haridwar-249 403 (Uttarakhand)

Attachment-II

Investigation Report
Reference Deviation No.:DV/20/003
Date: 27/10/2020

3. Naphthalene RS shall be used to qualify the working standard for Naphthalene and use for Limit of
Polymorphic test in raw material ( Mineral Oil USP)
Preventive Action-
1-Verified the qualification status of other available working standard
2- Training to be provided to concern person involve in preparation of STS and STP to identify the
such type of gaps (Uses of Non-qualified WS).

CAPA TCD – 31/03/2021

Sr. No. Investigato Departmen Designation Role Sign/Date

r Name t