Sr.

No Observed Non conformities Closing Date of Non conformities Classification of the Non conformities Closure of Audit Findings

1 Sampling area should be outside of approved RM store, once RM is approved by QC after

Raw Materials should be de-dusting outside the RM store after
sampling then it should be transferred to approved RM store but right now it exists into Closed Minor that materials moved to under test are once approved by QC
approved RM store which may cause mix up of approved and un approved material. then transfer to Rm approved Area
2 Weighing balance which is being used for dispensing of RM found without ID tag and without
The calibration tag has been placed & balance has been
calibration tag which may cause weight variation during dispensing of RM and impact the Minor calibrated
batch manufacturing process. Closed
3 The person who is dispensing the material is not using gloves/mask which may lead to The dispensing person is given training for using PPEs Recored
Major
contamination into the RM. Closed Attched
4 Dispensed raw material was kept on the floor after dispensing which needs to be kept in the
Critical
plastic bin. It may cause major cross contamination into the bulk. Closed 6 new cerates are handover to the store team
5 SOP of material dispensing not found in RM store. The person who is dispensing the RM SOP shared with store team along with training Sop & Traning
Minor
should know the procedure for which they need training. Closed Recored Attached
6 Drum of Glycerin B.No. D23090213 having green tag but nothing is mentioned on it. There
should be Item name, AR No. date of testing and expiry date properly mention on it. It seems Major All missing details have been added to the accpted label
that material is not traceable. Closed
7 Aflow Powder B.No. : 248 found without any identification tag. There should be Item name,
Critical All missing details have been added to the accpted label
AR no. and expiry date mentioned on it. Closed
8 Balance material of Item RR 1G1 and RR 1G33 found in a polybag on which there is no
Critical All missing details have been added to the accpted label
identification tag found for its material identification / Expiry date, It’s untraceable. Closed
9 Intensity of light is found very less in RM store. There should be sufficient light required in
this area (Recommended – 300 lux) , In Hazardous room there are non-hazardous material
being kept and there is no light in this area. The person is using mobile light to issue the RM. Major
It may cause mistakes during issue of raw material as the Identification tag should be Light has been installed in the hazards room & back side of raw
properly visible in available light. Closed material store there was low Intensity
10 Lot of dust found on the fire pipe line and duct in RM store , Recommended to do puff fall
Major
sealing in this area for maintaining better storage area. Closed
11 Following material found expired in the RM Store
DCG 20 – Expiry date 01-09-2021 Critical
ABS – Expiry date 09-05-2023 Closed Expired materiel has been transferred to a rejected area.

12 Hyaluronic Acid B.no. SHS/021 in-house manufactured on 03-08-2023, There is fungus found
in this SS container in which it is stored. Mr. JP has instructed to remove it from store Major
immediately to avoid any cross contamination in other raw material. Closed Moved this material to rejected Area
13 Lot of rejected / Expired material is found inside the approved material store corner. These
material should be kept in a separate room with lock and key to avoid any cross Major Expired materiel has been transferred to a rejected area.lock &
contamination into other raw material. Closed key Management design
14 Preparation record of R/O water not maintained after 12 th Oct 2023. Closed Minor
15 After making R/O water its being used for batch manufacturing for a week further which may
cause cross contamination into the bulk. R/O water must be used within 24 hr., Althoug It is Major
suggested to make day and use same day to avoid any possibility of cross contamination. Closed
16 Wax manufacturing Area – Found completely unhygienic, cleaning frequency needs to be
increased in this area to avoid any cross contamination. There is open space in the area of Major
exhaust fan from which insect can enter in this area. Needs to control. Closed
17 Some of the packaging material as Corr. Box, Plastic Lid, Jaar stored in wax filling area which
Minor
is not complies as per GMP. PM should not be stored in any manufacturing area. 11/4/2023
18 No record found for microbiology test of Swab taken for line clearance of mixing tank. They
Minor
are maintaining a register only in place of mentioning Test parameter and result. 11/4/2023
19 Format Doc / Spec/RM/001 COA of raw material is not reviewed from last 3-years. As per
Minor
SOP we have to review all the document’s / formats at the frequency of 3-years. 11/4/2023
20 Ultra Healing Body Lotion B. No. : VUHL/1087 Manufactured on 9 th October but there is no
Minor
COA / Released report found in QC Lab where the product is finally packed on the line. 11/4/2023
21 Log sheet for batch traceability of concentrate manufactured for testing purpose is not
Minor
found. It is suggested to maintain the record for it further. 11/4/2023
22 D-Tan pack – 300g – Filling the operator doesn’t know the batch number for its traceability.
Weighing balance which is being used on this line is found without any identification/
Callibration tags. After filling this product is keeping on the floor in open environment to cool Critical
down which may cause contamination into the product as this area is not bacteria free area.
It is suggested to do area monitoring and its microbiological testing and share. 11/5/2023
23 Infeed tank for processing of RO water found without Lid, it may cause dust contamination,
insecticides inside the tank. Cleaning record of this tank is not available which needs to be
done fort night basis. As per discussion with the maint. Guys Mr. Survesh they are doing Critical
cleaning in a six-month interval. It may cause contamination in the purified water being used
for production. Closed Feed Water Tank was cleaned

Critical

24 ETP plant was not found in running condition. Immediate action required. Closed