DHOLKA

Area Sr. No Observation Improvisation

01 All Quality Control Packaging department analysts Job Job descriptions updated
Description is not updated till date.
02 All Packaging material analysts are working without Analyst Training imparted to concern in charge to perform the
Qualification as per SOP No. DQC045-08. Therefore, Analyst qualification before allocating work.
Qualification should be performed immediately.
03 Synchronized clock not available in Packaging material Informed to engineering department to procure synchronized
Quality Control department. Time need to be in line with all clock
instrument/Equipment in Packaging material department.
04 Analytical Balances Id CD/QC/INS/079 and CD/QC/INS/079 Password protectd.
are not password protected. Hence, date and time could be
change easily. Violation of CSV.
MPB-Quality Control
05 Packaging Materials related analytical data is not reviewed by Imparted training to in charge all raw data should be reviewed
(Packing Material)
certified reviewer. properly.
Production
06 SAP login available for three persons in Packaging materials Strictly instructed to team members don’t share their password
and all persons used SAP for specification preparation and to others and use their password for login.
sticker label generate mentioned in Job Description.
07 On the bottles of analytical chemicals (NaOH, Acetone, Ethyl Status labels updated.
Acetate and Morpholine), “date of opening” and “used before”
label is not maintained as per SOP No. DQC390 Management
of Laboratory reagent.
.
08 For Ethiopia plant related Packaging material analysis data is Through change control procedure incorporated.
recorded in manually prepared “Record of Analysis”
(worksheet) and COA.
Above procedure is not part of any SOP.
09 For ANDA (US market) products data entry, data reviewed
and locked by reviewer in LIMS as per SOP No. DQC207.
Also said activity is done manually as per SOP No. DQC281
and print on preprinted stationery which is repeated activity.
This should be performed as per SOP No. DQC281.
ANKLESHWAR
Area Sr. Observation Improvisation
No

As per observations of previous year, engineering has revised about Current updated layouts wrt SOP and facility are available
Engineering 01
80 layouts / AHU drawings throughout facility, wherever required. with uniformity of information.
Global CAPA verification wrt missing entries in the usage log book This observation is verified throughout various
in weighing balance manufacturing blocks for all weighing balances, for current
as well as previous year. Findings are addressed and CAPA
is taken.
Omega/ MPP-IV 02 Benefit of this is, implementation of Quality Culture for
global CAPA is now introduced for the observations yet to
be addressed. This concept is applicable to those findings,
which are common throughout facility.
BPR of NL final stage is revised, to avoid replication of operations BPR is under signing, after approval of “Regulatory
MPP-IV 03 and simplification of instructions. department.
Questionnaire as well as answer sheets of SOP PR033 version No.9 Rectified in Omega block. Global CAPA is under progress.
Omega 04 are printed back to back and being used for assessment and filed in
the respective person training file
05 SOP HR009 for working of security is reviewed. Suggestions are Revised SOP is now in-line with SOP of SOP. All registers
HR & Admin implemented. Register not part of QMS is removed from SOP. will be now under issue control, once the SOP is made
Annexure not part of SOP are introduced. effective.

Since the Manufacturing Excellence Team started independent operation ( May,2021) , substantial savings amounting to Rs. 469.45 lacs (as mentioned below) in utility cost is
achieved by plant based on the in-depth study and suggestions by team .The team also coordinated with the concerned area heads and guided them as and when required. The
saving are not one time savings but will continue for future also based on the assumption that the system will be followed continuously i.e. continuous monitoring of utility and
regular maintenance. The savings in previous year (2021) is excluded. In addition it has also resulted in indirect benefits e.g. with reduction in water consumption the premises are
cleaner since water which was flowing on roads due to wastage is stopped and reduction in discharge of ETP water which also costs.
All this was made possible with active support from Plant head and team and improvement in efficiency, control on leakages etc.

SAVINGS IN UTILITY COST (2022 v/s 2021)

 Area Unit Comparison Consumption Corresponding Consumption Savings Rate per Amount ETP
(2021) INR
(2022) (2022) Period (2021) Units Unit Average
In Lacs

Steam Ton 2022 31198 2021 35332 4134 5150.00 212.90

Water K.L. 2022 68873 2021 85200 16327 65.52 10.69

Power Units 2022 14476470 2021 15276090 799620 8.20 65.56

ETP Discharge K.L. 2022 24927 2021 20593 -4334 65.00 -2.81

Total Savings (INR. In lacs) 286.34

discharge is increased as manufactured quantity of year 2022 is 426409 kgs against that 41554 kgs manufactured in 2021.

SAVINGS IN UTILITY COST (April 2023 v/s April 2022)

Area Unit Comparison Consumption Corresponding Consumption Savings Rate per Amount
(Till April INR
Period (Till April 2023) Period Units Unit Average
2022)
(Till April (Till April 2022) In Lacs
2023)

Steam Ton 2023 10085 2022 11384 1229 5150.00 51.93

Water K.L. 2023 22759 2022 23059 300 65.52 14.56

Power Units 2023 4590630 2022 4731585 140955 8.20 11.55

ETP Discharge K.L. 2023 10373 2022 9565 -808 65.00 -0.5

Total Savings (INR. In lacs) 77.54

SAVINGS IN UTILITY COST (April 2023 v/s April 2021)

 Area Unit Comparison Consumption Corresponding Consumption Savings Rate per Amount INR
(Till April
Period (Till April 2023) Period Units Unit Average In Lacs
2021)
(Till April (Till April 2021)
2023)

Steam Ton 2023 10085 2021 12701 2616 5150.00 51.92

Water K.L. 2023 22759 2021 33117 10385 65.52 14.58

Power Units 2023 4590630 2021 5182455 591825 8.20 32.46

ETP Discharge K.L. 2023 10373 2021 12874 2501 65.00 06.61

Total Savings (INR. In lacs) 105.57

Grand total (INR. In lacs) 469.45

JAMMU
Area Sr. No Observation Improvisation
 01 AHU supply of change rooms of soft gel manufacturing were
not operational up to 11:00 AM while, plant is functioning
since 07:15AM.
Informed to area in charge and HR Head to start the AHU
before start of manufacturing activities to avoid cross
Unit-I ,
contamination in change rooms.
Service Floor Engineering
02 Entire service floor found dirty. In areas, cleaning has not been
performed since long. Water tank used for collection of A.C.
drain is found in uncleaned condition. Water clogging on the
floor and many dead pigeons are found in the area. On the
entire service floor, feathers & beats are observed.

03 Dispensing room No.-2, wall side epoxy and coving need to fix
as, it was found faded.
04 During review of punch issuance and retrieval logbook,
following gaps were identified.
a. Need to update index of logbook. Some product punch sets
Factory - A
are double creating lot difficulty to find out the exact record of
issuance in the logbook.
b. The page of existing logbook is torn. Needs to handled
properly, to keep data is safe.

07 In stair case sealing, cracks are observed. Need to fix this

Unit-II, cracks.
Soft gel Ware House Some pallets were damaged. Need to replace the damaged one.

08 Separate gowning shall be followed for sampling of API and

excipients to prevent the cross contamination of material.
RM Sampling
Currently, same/single gowning is used in both areas.