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Sr. No.

Description Performance
1
IPQA Activity
Trained and experienced persons are
available to implement the online in
process check documentation.


80% online
2
Documentation
work on revision of SOP.
a. Q.C. Revision Completed
b. ENG. Revision Complete
c. HR revision Complete
c. Production Revision in process
d. Change control/ Market complaint/oos


80% online

Sr. No. Description Performance
3
Artwork

Regular 3
rd
party artwork development
and Crescent artwork is in Process.



75 % online
14 New products Approved
15 Products under process
4
FDA work
( For the 3
rd
parties and CFPL FDA
License)
Renewed Mfg. License
Extended WHO Certificate

90% online
CTL 24 Approval

Valid till 19.06.2018
Valid till 19-01-2014
ISSUES RELATED TO QUALITY
a. Incomplete Batch records especially Batch
packing part.
b. Improper batch reconciliation.
c. Insufficient weighing balances in the packing belt.
d. Insufficient weighing balances in the
compression area for weight variation.
e. Improper handwriting to fill log books & batch
records.
f. Improper Relative Humidity in Plant.
g. Material retesting is not following
h. Material labeling system improper.
i. Sampling procedure not follows as per SOP. 30-
40% sampling done outside sampling booth.
j. Complete testing not in practice for all the
materials.
k. Finished COA not receiving timely.
l. Defoiling activity is in secondary packing hall.
m. Fumigation not in practice.
n. Flies & Lizard roaming inside plant.
o. Pest control activity is not up to standard.
p. Expired chemicals available in QC.
q. Purified water loops coding required.
ISSUES RELATED TO QUALITY
Sr. No. Document Name Status Remarks
1 SOP & List of SOP Available
2 Site Master File Available
3 Quality Manual Available
4 Validation Master Plan Available
5 Organization chart Available
6 List of technical staff Available
7 APQR Not Available Only selected products
data available of 2011
8 Vendor list of raw material Available To be updated
9 Vendor list of packing material Available
10 Training Record Available
11 Self inspection Record Available
12 Validation cleaning Available
13 Validation process Available
14 List of product Available
DOCUMENTATION STATUS
Sr. No. Document Name Status Remarks
15 Product Recall Record Not Available No recall
16
Market complaint Record
Available
17 Validation of all equipment &
Machinery
Not Available Not Performed
18 Qualifications Doc.
DQ/IQ/OQ/PQ
Not Available Not Performed
19 Validation of HVAC system Available
20 Water system validation of
three phase
Available
21 Trend analysis for water
system
Available
22 Deviation Record Available
23
Change control record
Available
24 Plant Layout Available
DOCUMENTATION STATUS
THANK YOU