S.

NO

OBSERVATIONS/FINDING

CLASSIFICATION
(CRITICIAL/MAJO
R/MINOR)

CAPA/PLAN OF ACTION

While entering inside the factory

1 premises, security is failed to note down
the details about the visitors

Adequate instructions initiated

Company dress code for visitors is handed

2 over at contaminated areas, which intern
leads to contamination to the products

visitors to follow protocol

Company employees are found with

3 bare foot inside the premises. Which is NC
with respective to the safety & GMP.

Required measures taken

There is no separation in between

4 QUARANTINE AREA & APPROVED AREA.
Needs to be marked with yellow lines.

instructions are already

initiated

BIN cards are not maintaining for both

RM & PM.

required formats to be procured

soon

Dispensing of liquid materials from

6 barrel is performing outside the LAF,
which leads to contamination.

instructions are already given

for necessary requirement

SOP's & LOG sheets are not displayed

7 in all over the areas like Stores,
Manufacturing, Filling and Packing, etc.

yes display panels are to be

procured-already ordered.

TASK ASSIGNED
TO

DEAD LINE

S.NO

OBSERVATIONS/FINDING

CLASSIFICATION
(CRITICIAL/MAJO
R/MINOR)

CAPA/PLAN OF ACTION

DM plant is not in a working condition.

Its under maintenance. Need to be
8 identifying the filters used in DM plant.
Only one UV lamp was available all over
the factory premises.

its in working condition

Cleaning procedures for Mfg tanks,

Water storage tanks, holding tanks,
transfer pumps need to be reviewed once
9
again. Found detergents are using to
clean the tanks, we should not use
detergents for tank cleaning.

no its product specific it will

done as your product desires.

Load cells are available with the

10 manufacturing tank, but not yet
calibrated.

it will done

No marking or identification for

drainage holes at manufacturing area. All
11 drainage holes to be equipped with non
return drain valves to prevent
contamination.

instructions initiated

12

Bacteriostatic filters need to be

implement for compressed air.

filters procurement initiated

13

Empty tube cleaning practices not

available with the existing facility.

it will be done

TASK ASSIGNED
TO

DEAD LINE

S.NO

14

OBSERVATIONS/FINDING

Personal hygiene found to be poor

inside the factory premises.

Washing areas should be provided

15 with steam line facility and purified water
facilities to clean the utensils.

16

For secondary packing area, AHU's not

provided.

17

Packing material store found with

space constraints.

18

External calibrations certificates are

not available as on date/expired in 2015.

Pest control system/agreement was

19 expired in July 2015. Needs to be renewed
on priority.

20

Internal audit check list needs to be

reviewed again.

21 Viscometer is not available right now.

CLASSIFICATION
(CRITICIAL/MAJO
R/MINOR)

????

CAPA/PLAN OF ACTION

?????

TASK ASSIGNED
TO

DEAD LINE

S.NO

22

OBSERVATIONS/FINDING

Air monitoring system/practices not

available with the facility.

Found poor safety systems in all over

the factory premises. Like list of fire
extinguishers, list of persons who can able
23 to handle these fire extinguishers,
Assembling point if something happened
inside the factory, etc Need to be take
care by the management.
At the receipt of packing material
24 entry, air curtain not available. Need to
implement immediately.
Quality policy was not displayed in
and outside of the factory premises.
25 Needs to be displayed in security room,
conference room, MD cabin, QC/QA &
production departments.

26 Environmental policy not yet defined.

CLASSIFICATION
(CRITICIAL/MAJO
R/MINOR)

CAPA/PLAN OF ACTION

TASK ASSIGNED
TO

DEAD LINE

RESPONSE

RESPONSE

RESPONSE

RESPONSE