1

LIST OF CAPA

Status => Open

CAPA CAPA
CAPA Ref. Source Initiating Source of Plant CAPA Responsible Responsible Agreed Extended Closing Status Completed?
No. of CAPA Date CAPA (Ref. No.) Department Person Timeline Timeline Date (Y/N)

1 Change 01-01-2020 CCR/SDU/19/639 SDU New logbook to be QC 20-04-2020 Open N

Control introduced for new
instrument.

2 Change 01-01-2020 CCR/SDU/19/639 SDU Machine list and QC 40424 09-04-2020 Open N
Control calibration schedule to
be updated by including
Gas machine.

3 Change 01-01-2020 CCR/SDU/19/639 SDU Operational SOP and QC 30-03-2020 Open N

Control calibration SOP to be
prepared & approved
and training to be
conducted.

4 Change 01-01-2020 CCR/SDU/19/639 SDU Operational SOP and QC 30-03-2020 Open N

Control calibration SOP to be
prepared & approved
and training to be
conducted.

5 Change 01-01-2020 CCR/SDU/19/639 SDU New Gas QC 18-03-2020 Open N

Control chromatography (GC)
machine to be installed
and qualification to be
done as per protocol.

6 Change 02-01-2020 CCR/SDU/20/004 SDU Provisional/Approved QA 04C39 30-01-2020 Open N

Control vendor list of RM & PM
to be updated and
approved.

7 Change 02-01-2020 CCR/SDU/20/005 SDU SOP{(SOP/R&D/033) to AMDV 40213 20-02-2020 Open N

Control be updated and
implemented through
training.

8 Change 02-01-2020 CCR/SDU/20/006 SDU SOP(SOP/R&D/074) to R&D 40483 20-02-2020 Open N

Control be updated and
approved through
training.

9 Change 02-01-2020 CCR/SDU/20/007 SDU SOP(SOP/R&D/227) to AMDV 40213 20-02-2020 Open N

Control be updated and
implemented through
training.

10 Change 05-01-2020 CCR/SDU/20/011 SDU Validation master plan QA 04C20 30-01-2020 Open N
Control of SDU (VMP/SDU-
QA/003) to be updated
and approved.

11 Change 14-01-2020 CCR/SDU/20/023 SDU secondary BPR (list Production 04B80 08-03-2020 Open N
Control enclosed) of SDU
products to be updated
by removing scotch
tape and approved.

12 Change 13-01-2020 CCR/SDU/20/020 SDU user requirement Production 20-02-2020 Open N

Control specification(URS) to
be prepared for Auto
carton packaging
machine and approved.

13 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU The availability of the QA 04C20 30-06-2020 Open N
SI/20/0001 Inspection QA/27/19 risk assessment for
major machine will be
confirmed during the
arrival of the machine.
The SOP for
Preparation, Review and
Approval of qualification
protocols and carrying
out qualification of
facility, utility and
equipment
(SOP/QA/007) will be
revised considering
Risk Assessment
approach.

14 Change 09-01-2020 CCR/SDU/20/018 SDU specification of R&D 25-02-2020 Open N

Control Losartan potassium
tablet USP
(25mg,50mg&100mg) to
be updated & approved.

15 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU ?Documentation control QA 15-03-2020 Open N

SI/20/0003 Inspection QA/27/19 and management
(SOP/QA/002) SOP to
be reviewed.?Issue
date, effective date and
review due date of all
specification, analytical
method and analytical
report sheet to be
stamped after approval
of the document

16 Change 09-01-2020 CCR/SDU/20/018 SDU STP of Losartan R&D 25-02-2020 Open N

Control potassium tablet USP
 Control potassium tablet USP
2
(25mg,50mg&100mg) to
be updated & approved.

17 Change 09-01-2020 CCR/SDU/20/017 SDU SOP(SOP/QC/037) to QC 20-02-2020 Open N

Control be updated and
approved.

18 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU New log book needs to QA 30-06-2020 Open N
SI/20/0004 Inspection QA/27/19 be raised with inclusion
of checked by option

19 Change 09-01-2020 CCR/SDU/20/016 SDU protocol validation QA 16-02-2020 Open N

Control (primary stage) to be
done and report to be
prepared and sample to
be collected for stability
study.

20 Change 09-01-2020 CCR/SDU/20/016 SDU Based on PV report, Production 05-03-2020 Open N

Control commercial
BPR(primary) to be
prepared and approved.

21 Change 07-01-2020 CCR/SDU/20/015 SDU Requalification protocol QA 15-02-2020 Open N

Control of Double door
autoclave(QCI-262) to
be updated and
approved.

22 Change 09-01-2020 CCR/SDU/20/010 SDU new two HPLC(PDI-292 R&D 20-02-2020 Open N
Control & PDI-293) to be
installed & connected
with empower server
system and
qualification to be done.

23 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU New log book needs to QA 30-04-2020 Open N
SI/20/0008 Inspection QA/27/19 be raised with exclusion
of printed option
24 Change 09-01-2020 CCR/SDU/20/010 SDU After connecting HPLC IT 20-02-2020 Open N
Control with empower server
system verification to
be done.

25 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU Microbiology report QA 05-01-2020 Open N

SI/20/0009 Inspection QA/27/19 needs to be attached

26 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU SOP/QA/061, Rev. 07 QA 04C39 27-02-2020 Open N
SI/20/0010 Inspection QA/27/19 needs to be revised with
inclusion of reschedule
management of Vendor
Audit

27 Change 09-01-2020 CCR/SDU/20/010 SDU Machine list & R&D 08-02-2020 Open N
Control calibration schedule to
be updated and
approved.

28 Change 09-01-2020 CCR/SDU/20/010 SDU Logbook nto be R&D 10-02-2020 Open N

Control itroduced for new two
HPLC (PDI/292 & PDI-
293).

29 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU Logbook has been QA 04C39 27-02-2020 Open N
SI/20/0011 Inspection QA/27/19 updated and
SOP/QA/061, Rev. 07
needs to be revised with
inclusion of code
numbering column in
Appendix-P

30 Change 02-01-2020 CCR/SDU/20/003 SDU based on PV report, Production 05-03-2020 Open N

Control commercial BPR
(Primary) to be
prepared and approved.

31 Change 14-01-2020 CCR/SDU/20/034 SDU Existing air bone QC 20-02-2020 Open N

Control particle counter(QCI-
046) to be returned to
the supplier and
machine list &
calibration schedule to
be updated & approved
by removing QCI-046.

32 Change 14-01-2020 CCR/SDU/20/034 SDU Machine list to be QC 28-02-2020 Open N

Control updated by including
new air bone particle
counter(SMICAPC01).

33 Change 20-01-2020 CCR/SDU/20/035 SDU API lots to be retested QC 30-01-2020 Open N

Control using validation method
as per SOP.

34 Change 20-01-2020 CCR/SDU/20/035 SDU Finished product to be QC 05-02-2020 Open N

Control retested in QC lab
using validated method
for coated tablets as
well after packaging.

35 Change 20-01-2020 CCR/SDU/20/035 SDU Master formula to be R&D 10-02-2020 Open N

Control prepared for exhibit
batch of Losartam
potassium tablet,USP
100mg.

36 Change 20-01-2020 CCR/SDU/20/035 SDU Comparative Dissolution R&D 15-02-2020 Open N

Control study protocol to be
prepared and approved.

37 Change 20-01-2020 CCR/SDU/20/035 SDU A summary report to be R&D 20-02-2020 Open N

37 Change 20-01-2020 CCR/SDU/20/035 SDU A summary report to be R&D 20-02-2020 Open N
3
Control prepared based on data
of this Feasibility
batch(B/N.: T3789003)
and declared as exhibit
batch.
38 Change 20-01-2020 CCR/SDU/20/035 SDU Hold time study QA 25-02-2020 Open N
Control protocol to be prepared
and cleaning validation
assessment to be done
for Losartan potassium
tablet,USP 100mg.

39 Change 20-01-2020 CCR/SDU/20/035 SDU Protocol BMR&BPR of R&D 29-02-2020 Open N

Control Losartam potassium
tablet,USP 100mg to be
prepared and approved
for next exhibit batches.

40 Change 20-01-2020 CCR/SDU/20/035 SDU Remaining bulk tablets Production;R&D 10-03-2020 Open N
Control of Feasibility
batch(batch
no.:T3789003) to be
packed in GMR facility
after retest of coated
tablets in QC using
exhibit batch BPR.

41 Change 20-01-2020 CCR/SDU/20/035 SDU Stability study protocol QC 15-03-2020 Open N

Control & photo stability
protocol to be prepared
and approved.

42 Change 20-01-2020 CCR/SDU/20/035 SDU Sample to be collected QA 20-03-2020 Open N

Control for stability study from
existing Feasibility
batch (B/N.:T3789003)
as well as next
manufacturing exhibit
batches.

43 Change 20-01-2020 CCR/SDU/20/035 SDU New two exhibit R&D 30-03-2020 Open N
Control batches to be
manufactured and
prepared a report
considering
manufactured three
exhibit batches.

44 Change 15-01-2020 CCR/SDU/20/036 SDU SOP(SOP/QC/221) to QC 28-02-2020 Open N

Control be updated and
approved.

45 Change 26-01-2020 CCR/SDU/20/059 SDU PPS and material Production 20-02-2020 Open N
Control requisition form for
Ecosprin 75
Tablet(Export to
Srilanka) to be prepared
& approved for export to
Srilanka.

46 Change 29-01-2020 CCR/SDU/20/068 SDU Protocol to be prepared R&D 15-02-2020 Open N

Control and approved for
primary stage
verification of A-Fenac
SR tablet.

47 Change 29-01-2020 CCR/SDU/20/068 SDU Primary BPR of A- Production 15-02-2020 Open N

Control Fenac SR tablet to be
prepared and approved.

48 Change 29-01-2020 CCR/SDU/20/068 SDU Primary stage QA 28-02-2020 Open N

Control verification to be done
and report to be
prepared.

49 Change 14-01-2020 CCR/SDU/20/027 SDU Analytical QA 25-02-2020 Open N

Control method(RMSM/QC/197)
and
ARS(RMATRS/QC/197)
of PW to be updated
and approved.

50 Change 29-01-2020 CCR/SDU/20/047 SDU Temperature & RH Engineering 28-02-2020 15-03-2020 Open N
Control monitoring device to be
relocated for hot & cold
spot to 8-middle & 4-top
respectively and
pictorial verification to
be done.

51 Change 27-01-2020 CCR/SDU/20/066 SDU Sample to be collected QA 20-03-2020 Open N

Control from 1st commercially
packed batch for
stability study.

52 Change 27-01-2020 CCR/SDU/20/067 SDU Sample to be collected QA 40260 20-03-2020 Open N

Control from 1st commercially
packed batch for
stability study.

53 Change 28-01-2020 CCR/SDU/20/069 SDU New source of QA;Warehouse 15-03-2020 Open N

Control mcrocrystallin cellulose
to be implemented and
evidence to be
collected.

54 Change 30-01-2020 CCR/SDU/20/070 SDU cleaning validation QA 04A81 15-02-2020 Open N

Control assessment of Azin
PFS 15ml to be done
and report to be
 and report to be 4
prepared.

55 Change 30-01-2020 CCR/SDU/20/070 SDU process validation to be QA 04B30 20-03-2020 Open N

Control done & report to be
prepared for Azin PFS
15ml.

56 Change 30-01-2020 CCR/SDU/20/070 SDU Based on PV Production 30-03-2020 Open N

Control report,commercial
BMR&BPR to be
prepared for Azin PFS
15ml.

57 Change 29-01-2020 CCR/SDU/20/072 SDU SOP(SOP/WH/004) to Warehouse 03687 20-03-2020 Open N

Control be updated and
implemented through
training.

58 Change 29-01-2020 CCR/SDU/20/073 SDU SOP(SOP/WH/007) to Warehouse 20-03-2020 Open N

Control be updated and
implemented through
training.

59 Change 30-01-2020 CCR/SDU/20/074 SDU packaging material QC 04A71 15-03-2020 Open N

Control (carton,.foil&insert)of
whilst tablet to be
developed & approved.

60 Change 30-01-2020 CCR/SDU/20/071 SDU protocol to be prepared R&D 30-03-2020 Open N

Control for source validation of
A-cal 500,A-cal 250,A-
cal D(15pcs)&A-cal
D(30pcs) tablet and
approved.

61 Change 30-01-2020 CCR/SDU/20/071 SDU source validation to be QA 04B30 30-06-2020 Open N

Control done & report to be
prepared.

62 Change 30-01-2020 CCR/SDU/20/071 SDU sample to be collected QA 40260 30-06-2020 Open N

Control for stability study from
two validation batches.

63 Change 12-01-2020 CCR/SDU/20/021 SDU SOP(SOP/SDU- Production 04A56 05-03-2020 Open N

Control PRO/004) to be
updated & implemented
through training.

64 Change 13-01-2020 CCR/SDU/20/022 SDU SOP(SOP/SDU- Production 04A56 05-03-2020 Open N

Control PRO/142) to be
updated and
implemented through
training.

65 Change 16-01-2020 CCR/SDU/20/041 SDU New packaging material PMD;QC 04A71 28-02-2020 Open N
Control of Maxima 20 capsule
& Maxima 40 capsule
to be developed and
approved.

66 Change 04-02-2020 CCR/SDU/20/076 SDU Primary stage validation QA 40293 15-03-2020 Open N
Control of A-fenac SR tablet to
be done & report to be
prepared and sample to
be collected for stability
study.

67 Change 04-02-2020 CCR/SDU/20/076 SDU Based on PV Production 04A57 25-03-2020 Open N

Control report,BPR(Primary) of
A-fenac SR tablet to be
updated and approved.

68 Change 03-02-2020 CCR/SDU/20/077 SDU Coating BMR of Rostab Production 20-02-2020 Open N
Control 20 tablet(100000tab) to
be updated & approved.

69 Change 04-02-2020 CCR/SDU/20/075 SDU Dehumidifier to be QA;QC 10-03-2020 Open N

Control installed in sample
receiving room(3035)
and thermal mapping to
be done.

70 Change 04-02-2020 CCR/SDU/20/075 SDU Operation and QC 30-03-2020 Open N

Control preventive maintenance
SOP to be prepared
and implemented
through training.

71 Change 04-02-2020 CCR/SDU/20/075 SDU Machine list and Engineering ;QC 15-04-2020 Open N
Control preventive maintenance
schedule to be updated
and approved.

72 Change 23-01-2020 CCR/SDU/20/055 SDU TOC QC 25-02-2020 Open N

Control Analyzer(BQCTOCO1)
to be transfere from
room no.5039 to room
no.5022 and calibration
to be done.

73 Change 23-01-2020 CCR/SDU/20/055 SDU Machine list & QC 10-03-2020 Open N

Control calibration schedule to
be updated and
approved.

74 Change 16-01-2020 CCR/SDU/20/039 SDU Excel sheet of long QA;QC 05-03-2020 Open N
Control term stability study
products(list enclosed)
to be updated and
excell sheet to be
validated.
 5
75 Change 26-01-2020 CCR/SDU/20/060 SDU New source of colloidal Production;Warehouse 25-03-2020 Open N
Control Dioxide
NF(code:1014021595)
to be used in products
and evidance to be
collected.
76 Change 23-01-2020 CCR/SDU/20/054 SDU Primary BPR of Liptor Production 04B89 29-02-2020 Open N
Control 10 tablet to be updated
and approved.

77 Change 26-01-2020 CCR/SDU/20/058 SDU Specification,Analytical QC 40371 10-03-2020 Open N

Control method&Analytical
report sheet of
Paracetamol to be
updated and approved.

78 Change 04-02-2020 CCR/BLS/20/042 SDU HPLC water purification QC 25-02-2020 Open N

Control system (QCI-037) to be
transferred to BLS QC
and machine list to be
updated.

79 Change 16-01-2020 CCR/BLS/20/038 SDU Relevant drawing of Engineering 25-02-2020 Open N

Control level-04(Room no:4083)
to be change and
approved.

80 Change 28-01-2020 CCR/SDU/20/064 SDU One batch verification to QA 15-03-2020 Open N

Control be done and report to
be prepared.

81 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Job Delegation form will FAD 31-03-2020 Open N
SI/20/0028 Inspection FAD/20/03 be initiated

82 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Fire Fighting committee FAD 15-04-2020 Open N
SI/20/0030 Inspection FAD/20/03 will be revised and
updated

83 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Registar for first aid box FAD 30-04-2020 Open N
SI/20/0031 Inspection FAD/20/03 will be maintained as
per SOP
9SOP/FAD/007) and
refresher training will be
conducted to the
relevant FAD personnel
on SOP/FAD/007

84 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Appendix-B of SOP FAD 30-04-2020 Open N
SI/20/0032 Inspection FAD/20/03 (SOP/FAD/011) will be
followed; SOP/FAD/011
is to be revised with
synchronizing of
Appendix-A and
Accidant/Incident form
will be updated.

85 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Appendix-A (Visitor FAD 31-03-2020 Open N
SI/20/0033 Inspection FAD/20/03 slip) will be maintained
as per SOP/FAD/010
and refresher training
will be conducted to the
relevant FAD personnel
on SOP
(SOP/FAD/010)

86 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU SOP will be introduced FAD 30-05-2020 Open N
SI/20/0034 Inspection FAD/20/03 on Vehicle
Management

87 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Role profile of Md. FAD 30-04-2020 Open N
SI/20/0035 Inspection FAD/20/03 Habibur Rahman will be
revised

88 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Respective SOP FAD 30-05-2020 Open N
SI/20/0036 Inspection FAD/20/03 (SOP/FAD/008) will be
revised

89 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU SOP of cleaning FAD 30-05-2020 Open N
SI/20/0037 Inspection FAD/20/03 procedure of garments
(SOP/FAD/005) will be
revised
90 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU SOP on Canteen FAD 30-05-2020 Open N
SI/20/0038 Inspection FAD/20/03 Management
(SOP/FAD/016) will be
revised

91 CAPA/SDU- Self- 02-03-2020 SI/SDU- SDU Cleanliness will be FAD 30-04-2020 Open N
SI/20/0039 Inspection FAD/20/03 ensured and refresher
training will be
conducted to the
relevant personnel on
cleaning of canteen
management.

92 CAPA/SDU- Self- 03-03-2020 SI/SDU- SDU Procedure for air Engineering 40626 31-03-2020 Open N
SI/20/0040 Inspection ENG/20/04 balancing of HVAC
system
(SOP/ENG/191, Rev.
02) is to be revised.

93 CAPA/SDU- Self- 03-03-2020 SI/SDU- SDU Training file of Mr. Kibria Engineering 40286 31-03-2020 Open N
SI/20/0041 Inspection ENG/20/04 Alamin and Mr.
Mahabub Hasan Shuva
is to be updated and All
training file of
Engineering personnel
will be checked and
updated (If required)
 6
94 CAPA/SDU- Self- 03-03-2020 SI/SDU- SDU Standard Preventive Engineering 40494 30-04-2020 Open N
SI/20/0043 Inspection ENG/20/04 Maintenance Procedure
of Machineries
(SOP/ENG/072) will be
revised to inclusion of
machine list
arrangement procedure

95 CAPA/SDU- Self- 03-03-2020 SI/SDU- SDU SOP/ENG/110 will be Engineering 40493 31-03-2020 Open N
SI/20/0045 Inspection ENG/20/04 revised to inclusion of
purpose. And refresher
training is to be
conducted to the QA
personnel on
preparation,
authorization and
distribution of standard
operating procedure
(SOP/QA/001) who are
perform the checking
and issuing of SOP

96 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU ID will be made IT 30-03-2020 Open N

SI/20/0024 Inspection PRO/20/01 available at access
control device of
production floor

97 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Inactive/Damaged IT 30-03-2020 Open N

SI/20/0025 Inspection PRO/20/01 access control device
will be repaired and
access control device of
other areas of
production floor will be
checked & repaired if
found damaged/inactive

98 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Existing wear & tear Production 40301 15-04-2020 Open N
SI/20/0014 Inspection PRO/20/01 gasket will be placed
with new one to
maintain differential
pressure within
specified limit.

99 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Access of relevant Production 04328 Open N
SI/20/0016 Inspection PRO/20/01 executives to wash out
area will be ensured
100 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Door gasket will be Production 04A56 14-03-2020 Open N
SI/20/0017 Inspection PRO/20/01 made available

101 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Logbook format will be Production 04A39 30-03-2020 Open N
SI/20/0022 Inspection PRO/20/01 synchronized with the
respective SOP and an
awareness build up
training will be
conducted to relevant
operators on
Preparation and use of
cleaning agent and
antiseptic solution in
manufacturing area
(Ref. no. SOP/SDU-
PRO/067)

102 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Log book for shoe Production 40306 30-04-2020 Open N
SI/20/0023 Inspection PRO/20/01 cleaning will be
introduced

103 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Leakage in mentioned Engineering 40240 05-03-2020 Open N
SI/20/0026 Inspection PRO/20/01 PW line will be repaired ;Production

104 CAPA/SDU- Self- 05-02-2020 SI/SDU- SDU Job delegation of all Production 04328 30-04-2020 Open N
SI/20/0027 Inspection PRO/20/01 responsible personnel
will be made available

105 Change 12-02-2020 CCR/SDU/20/102 SDU Specification,analytical QC 30-03-2020 Open N

Control report sheet and
analytical method of
Losart 100 tablet to be
updated.

106 Change 20-02-2020 CCR/SDU/20/100 SDU SOP for stability study QC 15-04-2020 Open N
Control management
(SOP/QC/200) to be
updated and approved
and implemented
through training.

107 Change 13-02-2020 CCR/SDU/20/099 SDU In-Use stability study QC 30-03-2020 Open N
Control protocol of Cipro-A eye
drops 5ml(STP-004/19)
to be updated and
approved.

108 Change 12-02-2020 CCR/SDU/20/098 SDU SOP for server IT 30-03-2020 Open N
Control maintenance and
monitoring to be
updated and
implemented through
training.

109 Change 11-02-2020 CCR/SDU/20/092 SDU Secondary BPR of Production 28-02-2020 Open N
Control Ecosprin 75 tablet
(G/S) to be updated and
approved.

110 Change 12-02-2020 CCR/SDU/20/095 SDU Specification of Cipro-A R&D 30-03-2020 Open N
Control drops, 5ml (FPSP/SDU-
R&D/066) to be updated
and approved.

111 CAPA/SDU- Self- 05-01-2020 SI/SDU- SDU Refresher training QA 04C39 27-02-2020 Open N
SI/20/0012 Inspection QA/27/19 needs to be conducted
 7
SI/20/0012 Inspection QA/27/19 needs to be conducted
to the relevant QA
personnel on Good
Documentation practice
(SOP/QA/003)

112 Change 12-02-2020 CCR/SDU/20/094 SDU Primary BPR of PPI 20 Production 28-02-2020 Open N
Control capsule (P/S)
(B.S:100000capsule) to
be updated and
approved.
113 Change 10-02-2020 CCR/SDU/20/090 SDU SOP(SOP/R&D/202) to R&D 30-03-2020 Open N
Control be updated and
implemented through
training.

114 Change 10-02-2020 CCR/SDU/20/089 SDU SOP(SOP/QC/045) to QC 30-03-2020 Open N

Control be updated and
implemented through
training.

115 Change 09-02-2020 CCR/SDU/20/088 SDU SOP(SOP/SDU- Production 30-03-2020 Open N

Control PRO/067) to be
updated and
implemented through
training.

116 Change 06-02-2020 CCR/SDU/20/086 SDU SOP for handling of Warehouse 25-03-2020 Open N
Control consumable items
(SOP/WH/019) to be
updated and approved.

117 Change 19-02-2020 CCR/SDU/20/117 SDU Automatic high speed Production;QA 30-03-2020 Open N
Control labeling machine to be
installed and pictorial
verification to be done.

118 Change 19-02-2020 CCR/SDU/20/117 SDU Operational SOP to be Production 05-04-2020 Open N
Control prepared and approved.

119 Change 26-01-2020 CCR/SDU/20/061 SDU Requalification protocol QA 15-03-2020 Open N

Control of Hot Air Oven(QCI-
054) (RQ-P/SDU-
QA/019) to be updaed
and approved.

120 Change 23-02-2020 CCR/SDU/20/110 SDU Analytical balance(QCI- QC 25-03-2020 Open N

Control 093, QCI-303 and QCI-
304) to be transfer from
room no.3029 to room
no. 3034 and calibration
to be done.

121 Change 23-02-2020 CCR/SDU/20/110 SDU Refrigerator (QCI-165) QA;QC 15-04-2020 Open N
Control to be transfered from
room no. 3034 to room
no. 3026 and verification
to be done.

122 Change 18-02-2020 CCR/SDU/20/113 SDU Layout drawing of level- Engineering 10-04-2020 Open N
Control 06 of SDU to be
updated after
modification of prefilter
washing and
drying(Room-6037).

123 Change 23-02-2020 CCR/SDU/20/120 SDU Process validation QA 25-04-2020 Open N

Control (primary stage) to be
done and report to be
prepared and sample to
be collected from two
validation batches.

124 Change 23-02-2020 CCR/SDU/20/120 SDU Protocol and Production;R&D 20-03-2020 Open N
Control BPR(primary) to be
prepared and approved
for process validation of
Losart 50 tablet.

125 Change 03-03-2020 CCR/SDU/20/122 SDU Protocol,BMR&BPR to Production;R&D 15-04-2020 Open N

Control be prepared for process
validation of TPC tablet.

126 Change 03-03-2020 CCR/SDU/20/122 SDU Cleaning validation QA 30-03-2020 Open N

Control assesment of TPC
tablet to be done and
report to be prepared for
TPC tablet.
127 Change 27-02-2020 CCR/SDU/20/130 SDU Source validation to be QA 15-05-2020 Open N
Control done and report to be
prepared for TPC tablet.

128 Change 27-02-2020 CCR/SDU/20/130 SDU Protocol to be prepared R&D 30-03-2020 Open N
Control for source validation of
TPC tablet.

129 Change 16-02-2020 CCR/SDU/20/097 SDU Cleaning validation QA 30-03-2020 Open N

Control assesment of Maxima
40capsule to be done
and report to be
prepared.

130 Change 16-02-2020 CCR/SDU/20/97 SDU Protocol,BMR&BPR to Production;R&D 15-04-2020 Open N

Control be prepared for process
validation of Maxima
40capsule.

131 Change 16-02-2020 CCR/SDU/20/97 SDU Based on PV Production 30-05-2020 Open N

Control report,commercial
BMR&BPR to be
 BMR&BPR to be
8
prepared for Maxima
40capsule.

132 Change 16-02-2020 CCR/SDU/20/97 SDU Sample to be collected QA 15-05-2020 Open N

Control for stability study from
consecutive two
validation batches.

133 Change 16-02-2020 CCR/SDU/20/97 SDU Process validation to be QA 15-05-2020 Open N

Control done and report to be
prepared for Maxima 40
capsule.

134 Change 03-03-2020 CCR/SDU/20/104 SDU Cleaning validation QA 30-03-2020 Open N

Control assesment of Doxy-A
capsule to be done and
report to be prepared.

135 Change 03-03-2020 CCR/SDU/20/104 SDU Protocol,BMR&BPR to Production;R&D 30-04-2020 Open N

Control be prepared for process
validation of Doxy-A
capsule.

136 Change 03-03-2020 CCR/SDU/20/104 SDU Based on PV Production 15-06-2020 Open N

Control report,commercial
BMR&BPR to be
prepared for Doxy-A
capsule.

137 Change 03-03-2020 CCR/SDU/20/104 SDU Process Validation to QA 30-05-2020 Open N

Control be done and report to
be prepared for Doxy-A
capsule.

138 Change 03-03-2020 CCR/SDU/20/104 SDU Sample to be collected QA Open N

Control for stability study from
consecutive two
validation batches.

139 Change 20-02-2020 CCR/SDU/20/101 SDU Specification, analytical QC 04A85 05-04-2020 Open N
Control method & analytical
report sheet of
Carvipress 12.5 tablet &
Carvipress 25 tablet to
be updated and
approved

140 Change 09-02-2020 CCR/SDU/20/087 SDU Packaging material (foil) QC 20-03-2020 Open N
Control of Azin 500 tablet to be
developed and approved

141 Change 06-02-2020 CCR/SDU/20/085 SDU Product packaging Production 28-02-2020 Open N
Control specification (PPS) of
Apitac 100 tablet
(export of Nepal) to be
updated & approved.

142 Change 09-02-2020 CCR/SDU/20/082 SDU Material to be released QC 40365 25-02-2020 Open N
Control based on chemical
analysis without
impurity test (NDMA,
NDEA and BMSA) test.

143 Change 09-02-2020 CCR/SDU/20/082 SDU After getting the QC 40365 05-03-2020 Open N
Control impurity test (NDMA,
NDEA and BMSA)
result another report
sheet to be prepared
with both chemical &
impurity test result.

144 Change 29-03-2020 CCR/SDU/20/207 SDU Production 40299 20-04-2020 Open N

Control Primary BPR of TPC
tablet (G/S) to be
updated and approved.

145 Change 24-03-2020 CCR/SDU/20/206 SDU IT;Production 40444 05-04-2020 Open N

Control Enclosed listed
(attached in CCR)
access control devices
to be deactivated and
pictorial verification to
be done.

146 Change 15-03-2020 CCR/SDU/20/154 SDU QA 04B29 30-04-2020 Open N

Control SOP for Training of New
& Existing Employee
(SOP/QA/005) to be
updated and
implemented through
training

147 Change 24-03-2020 CCR/SDU/20/203 SDU R&D 30-03-2020 Open N

Control Protocol to be prepared
and approved for
granulation stage
verification of Fast
tablet (B.S. 600000
tabs)

148 Change 24-03-2020 CCR/SDU/20/203 SDU Production 40303 30-03-2020 Open N

Control BMR (Core) of Fast
Tablet (600000 Tablets)
to be prepared and
approved

149 Change 24-03-2020 CCR/SDU/20/203 SDU QA 04B30 15-04-2020 Open N

Control Granulation stage
verification of Fast
 verification of Fast 9
Tablet (600000 tabs) to
be done & report to be
prepared.

150 Change 22-03-2020 CCR/SDU/20/193 SDU QA 10-05-2020 Open N

Control SOP (SOP/QA/105) to
be updated and
implemented through
training

151 Change 24-02-2020 CCR/SDU/20/125 SDU User requirement QC 40424 15-04-2020 Open N
Control specification (URS) of
Analytical balance to be
prepared & approved.

152 Change 05-03-2020 CCR/SDU/20/144 SDU QA 04B10 20-04-2020 Open N

Control Quality Manual
(QM/QA/001) to be
updated & approved
with required
modification.

153 Change 18-03-2020 CCR/SDU/20/182 SDU QA 40228 10-05-2020 Open N

Control PQ protocol of
Manufacturing
equipment (List
enclosed in CCR) of
SDU to be updated &
approved.

154 Change 06-02-2020 CCR/SDU/20/084 SDU QA 40228 15-03-2020 Open N

Control Re-qualification protocol
of pass-box (RQ-
P/QA/007) to be
updated and approved.

155 Change 06-02-2020 CCR/SDU/20/083 SDU QA 40228 20-03-2020 Open N

Control Requalification protocol
of sampling booth (RQ-
P/SDU-QA/006) and
Dispensing booth (RQ-
P/SDU-QA/003) to be
updated & approved.

156 Change 30-03-2020 CCR/SDU/20/209 SDU Production 40301 30-10-2020 Open N

Control BMR of SDU products
(List enclosed in CCR)
to be updated &
approved with required
modification.

157 Change 11-03-2020 CCR/SDU/20/159 SDU Production 40301 10-04-2020 Open N

Control BMR of Fast tablet
(Batch size: 600000
tabs) & Liptor 80 tablet
(Batch size: 100000
tabs) to be updated &
approved.

158 Change 29-03-2020 CCR/SDU/20/210 SDU QC 04A71 Open N

Control Packaging material
(carton) specification of
Amlopin 5 Tablet to be
updated & approved.

159 Change 29-03-2020 CCR/SDU/20/208 SDU QC 25-05-2020 Open N

Control SOP (SOP/QC/132) to
be updated and
implemented through
training.

160 Change 19-02-2020 CCR/SDU/20/116 SDU Production 40605 25-02-2020 Open N

Control BMR of Liptor 10 Tablet
to be updated &
approved.

161 Change 01-03-2020 CCR/SDU/20/134 SDU Production 45059 30-03-2020 Open N

Control Primary BPR (P/S) of
Limbix tablet to be
updated & approved

162 Change 04-03-2020 CCR/SDU/20/141 SDU Production 20-04-2020 Open N

Control BPR of A-Cal (30Pcs)
tablet to be updated &
approved.

163 Change 19-03-2020 CCR/SDU/20/194 SDU Production 04B80 20-04-2020 Open N

Control Secondary BPR(G/S) of
Azin 500 tablet & TPC
tablet to be updated &
approved.

163

Grand Summary(163) 163

 10

LIST OF CAPA

Status Id (Count)

1 Open 163

Grand Summary 163

 11

Id (Count)