Veritas Pharmaceuticals LTD: TO: Management Associates CC To: Honorable Chairman & Honorable VC &CEO

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Veritas Pharmaceuticals Ltd

House# 77, Road # 4, Block - C, Banani, Dhaka- 1213


Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Meeting Minutes
TO : Management Associates

CC to : Honorable Chairman
& Honorable VC &CEO

Date: 06th Nov 2021


The coordination meeting among the personnel of Veritas Pharmaceuticals ltd were held on 06th Nov 2021 at the factory premises. Honorable chairman sir chaired
the meeting. Honorable Vice chairman & CEO were also present.
Attendees present:

 Mr. Didarul Alam ( Manager Production ( plant in charge))


 Mr. Abul Fazal (Dy. Manager Production)
 Mrs. Kanis (Sr. executive QC)
 Mr. Shafiul Islam ( Eng. In charge)
 Mr. Mamun ( QA in charge)
 Mr. Ashik ( QC executive)
 Mr. Iftekhar ( Sr. officer FP Dist)
 Mr. Atik ( Officer)
 officials of Head Office

Following are the listing of the points discussed:


Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Department : Quality Assurance


Points Discussion & Approval
Sl. No. Responsibility Deadline from Head Status/Progress Remarks
Discussed/Agenda Action Decided
Office
Required IPQC Officer. Mr. Didar Bdjobs Circular
01 given
Mr. Tanjil
Projector required for Training purpose Mr. Didar 11.11.202 Available in factory
02
Mr. Ekram 1
Rack required in document archive room. Wooden rack
03 Md. Didural Alam
installed
QC equipment commissioning (IQ/OQ/PQ) Abdulla Al-Mamun/ Some are available
report not Found. 25.11.202
04 Mrs.Hosne Zamil
1
Aktari

05 External training required. Searching


Balance Required for IPQC Room. 25.11.202 Quotation
06 Abdulla Al-Mamun reviewing
1
07 IPC work done. Abdulla Al-Mamun Running
Pictorial diagram required in change room. 20.11.202 Pictogram pasted
08 Md. Didural Alam
1
Dress code not found for management and 20.11.202 Dress available
09 Abdulla Al-Mamun
non-management person. 1
Documentation
Required Objective and principles of cGMP 25.11.202 Done
11 Abdulla Al-Mamun
Training 1
25.11.202 continuing
12 Required GDP & GMP Training Abdulla Al-Mamun
1
13 Required Each section Some relevant standard Abdulla Al-Mamun 25.11.202 continuing
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

operating procedures [SOPs] 1
All Forms (Tag) Required updating. 25.11.202 Work in progress
15 Abdulla Al-Mamun
1
QMS Required updating. 25.11.202 Work in progress
16 Abdulla Al-Mamun
1
VMP Manual Required updating. 25.11.202 prepared
17 Abdulla Al-Mamun
1
All validation protocol not found. 25.11.202 continuing
18 Abdulla Al-Mamun
1
Documents List Not found. 25.11.202 done
19 Abdulla Al-Mamun
1
Sop List Required. 25.11.202 done
20 Abdulla Al-Mamun
1
Mr. Didar 25.11.202 done
21 Organogram found not Updated.
Abdulla Al-Mamun 1
Required APQR Documents. Mrs.Hosne Zamil Work in progress
25.11.202
22 Aktari
1
/ Abdulla Al-Mamun
Vendor selection sop not found. 25.11.202 done
23 Abdulla Al-Mamun
1
Site master file required to update. 25.11.202 Work in progress
24 Abdulla Al-Mamun
1
Form list not found. 25.11.202 done
25 Abdulla Al-Mamun
1
OOS document not found. Abdulla Al-Mamun/ Work in progress
25.11.202
26 Mrs.Hosne Zamil
1
Aktari
Updated specimen signature not found. 25.11.202 done
27 Abdulla Al-Mamun
1
Training for Officer (Training for Trainer) is 25.11.202 continuing
28 Abdulla Al-Mamun
required. 1
29 Risk management system not found Abdulla Al-Mamun 25.11.202 Work in progress
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

1
25.11.202 Work in progress
30 Cleaning validation SOP & record not found Abdulla Al-Mamun
1
Retention Sample Room
32 Retention sample rack not enough Md. Didural Alam Rack installed
33 Sample carrying box required available

Department : Quality Control


AC not functioning in QC functioning
01
documentation room
Required Printer for QC Report 25.11.202 Work in progress
02 Mr. Ekram
print for HPLC. 1
Documentation
Required Objective and principles Mr. Mamun 25.11.202 continuing
03
of cGMP Training. Mr. Ashik 1
Required Each section Some relevant Done
25.11.202
04 standard operating Mr. Ashik
procedures [SOPs] 1
Conduct Training program 25.11.202 continuing
05 Mr. Ashik
required. 1
GLP Manual not found. 25.11.202 prepared
06 Mr. Ashik
1
Updated Lab Safety Manual not 25.11.202 prepared
07 Mr. Ashik
found 1
Required STP, COA, and prepared
Mrs. Kaniz 25.11.202
08 Specification of All API, Excipient
Mr. Ashik 1
and Packaging
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

SOP of CRS handling not found prepared


Mrs. Kaniz 15.11.202
09
Mr. Ashik 1

Calibration Tools
Dissolution Tester calibration Communicated
tools not available. Mrs. Kaniz 25.11.202 with Equiptex,
10 Bangladesh
Mr. Ashik 1 scientific but not
found

Third Party Calibration required


Melting Point Apparatus.
Moist Heat Autoclave
Mr. Didar
Incubator 25.11.202
11 Mrs. Kaniz Work order given
Polarimetar 1
UV-Spectrophotometer Mr. Ashik
Balance
Reference Standards
Mr. Didar
Reference standard required for 04 CRS available
12 Mr. Manik
each product
Mr. Kaniz
Equipment required
Required Digital Refractor meter, Mr. Didar Paradise scientific
25.11.202 will give quotation
13 Conductivity meter. Mr. Shafiul
1
Mr. Kaniz
centrifuge machine maintenance 25.11.202 Paradise scientific
14 will give quotation
required 1
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Expired many testing reagent 25.11.202 Test reagent


15 isolated
1
Required Potentiometer for Raw 25.11.202 Quotation
16 searching
material test. 1
17 FTIR Required. Work order given
Karl Fischer (KF) Required. 25.11.202 Quotation collected
18 from paradise
1
Equipment qualification 25.11.202 Work in progress
19
document not found 1
AAS not functioning Ebox needs to be
Mr. Didar replaced then
20
Mr. Shafiul further diagnosis
will be required
Books required
BP 2021 (Photocopy) Mr. Didar
Martindate Requisition given
21 Mr. Manik
Merck Index USP 2021
(Photocopy)
Microbiology dept.
22 Microbiologist not available. Mr. Didar; Mr. Tanjil Not yet joined

Department : Production
Mr. Didar
Insufficient light in
01 Mr. Shafiul Requisition given
Production area.
Floor epoxy paint not
02 Work order given
satisfactory.
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

03 Annexure validity expired


Update Pictorial diagram For all dept. it is
04 in change room is ready
necessary
Required UV Light in
05 Requisition given
Dispensing booth
07 Room Diary Not Found. prepared

Process validation Report Mr. Mamun &


08 25.11.21 Work in progress
Not Found. Mr. Fazol
Daily accuracy check of
09 balance not found as per done
guideline.
Required man power
10 done
allocation List.
Production starts without IPQC officer
11
duly QA Approval. required
Production machinery
qualification documents Documents
13
not found provided by compiled
supplier
Documentation
Required Objective and Done
14 principles of cGMP
Training.
Conduction of training Training
15 continuing
program required.
Batch reprocess sop and prepared
16
record is not found.
Break down sop and prepared
17
record is not found.
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Hand washing sop and prepared


18
log book is required.
Required process Work in
19 25.11.21 progress
validation protocol.
Change parts staging sop prepared
20
and record not found.
Documentation not done Document
21 25.11.21 preparing
as per guideline.
Change control procedure Not followed yet
22 25.11.21
not followed.
On job training record Job training
23 done
not found.
Duly record of Work in
24 production activities not 25.11.21 progress
found
Production flow chart not prepared
25
found.
Job description not found Available at site
26 of action
at the site of action.
BMR &BPR not found at Available at site
27 of action
the site of action.
Required production Work in
28 25.11.21 progress
training manual.

Granulation Room
Technical data log prepared
31
book not found.
Blending Room
Technical data log prepared
34
book not found.
35 Sampling advice forms prepared
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

log book not found.


Tablet Compression Room 1&2
Ref. Hygrometer
Hygrometer not required &
36
calibrated Requisition
given
Technical data log not prepared
37
found.
Sampling advice forms prepared
38
log book not found.
WIP Room
24 hours power supply
42
required
Temperature & relative
43
Humidity not controlled
Bulk product container SOP not
45 handling is not prepared
satisfactory.
WIP standard SOP prepared
46
required
Coating Room
Work order
Coating machine
47 given to
calibration required. equiptex
Technical data log prepared
48
book not found.
Sampling advice forms prepared
49
log book not found.
Rust found on spray Rust remove
50
gun.
Blister Room-2
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

IPQC officer
51 line clearance required
required
Hand gloves and musk PPE maintaining
52 not found during now
blistering.
Blister Room-1
SS blister change parts HO approval
54 required
cabinet required
Technical data log prepared
55
book not found.
Capsule room
Sampling advice forms prepared
56
log book not found.
57 Room diary not found prepared

Packing area
Batch reconciliation Done
58
not duly done
Finished product not Work in
59 release as per QMS progress
procedure

Department : Engineering

Utilities validation &


qualification document not
01 compiled
found ( purified water,
compressed air, air handling)
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

All section required SS file Requisition


02
holder. given

All door and lock found Work order


03
functioning not properly. given

pressure differential measuring Requisition


04
device required given

Required packaging store Wall Work in


05
maintenance. progress

Required preventive
07 prepared
maintenance as per schedule.

Differential pressure not Chiller & filter


09
maintains. required

ETP operation manual ,cleaning


10 done
SOP & record required

Requisition
11 Lux meter required
given

Documentation
1 Objective and principles of cGMP done
2 Training required.

1 Required Each section Some


relevant standard operating prepared
3 procedures [SOPs]
1 Conduction of Training program
continuing
4 required.
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

1 HVAC Pre-Filter Cleaning and


done
5 record is needed.

1 Required Calibration records


maintained and calibration tags done
6
placed on the every instrument.
1 Sop for Incident management
prepared
7 Required.
Water distribution line
1
chlorination SOP and record not prepared
8
found
water system operation sop
1
required (start up and shut updated
9
down) up to date
2 Filter cleaning SOP and Log Book
prepared
0 Required.
2 Fire fighting certificate and In house
1 training Required. training given

2 Light shed cleaning sop


prepared
2 required.
2 Job description found not up to
updated
3 date.
2 Third party contract agreement
Not done
4 required

2
compressed air test required Not done
5
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

2
Water flow diagram not found prepared
6

2 Compressed air flow diagram


updated
7 required up to date

Department : Warehouse RM,PM,FP


4. Reject area required out of HO
04 approval
premises for rm, pm required
5. Vacuum cleaner required for Requisition given
05
De-dusting area.
HO
06 6. Required De-dusting Area. approval
required
7. All equipment, Materials Tagging Done
07 properly
Properly tagging and training
08 required.
8. Pest Killer not found. Pest killer installed
09 9. Safety equipment not found. Work in progress

10. uncontrolled documents Mini rack required


10 25.11.21
found but space not
enough
11. Apron and Shoes not
11 Apron made &
sufficient in Change Room. sufficient
Documentation
done
12 Required Objective and principles
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

of cGMP Training.
Required Each section Some relevant Doc preparing
13 standard operating continue
procedures [SOPs]
Conduct Training program continuing
14
required.
Prepared &
15 Bin card not found.
implemented
16 Vendor List not found. prepared
Vendor selection not done as per Required head office
17 approval
QMS procedure.
GRN form and sop required Not done
18 25.11.21
upgrading.
Quarantine Area
Quarantine Area required for done
19
packaging materials
Required balance.(capacity 50gm
22 Requisition given
to 1 kg)
Sampling Room
01 Insufficient sampling Tools. 15.11.21 Not available

02 Wash room not ready for use. HO approval required


Required Sampling booth Not done
06 25.11.21
Calibration.
07 Light not optimum
Raw material Warehouse
01 24 hrs AC required for cool room HO
& controlled room. approval
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

required
Segregation of raw materials from done
02
each other is required.
03 No thermal mapping conducted. Not done

Dispensing Room
Dispensing booth Calibration Not yet done
01 25.11.21
Required.
Required Balance with printer. HO
03 25.11.21 approval
(Capacity 10mg to 1 kg) required
Finished Products Store
No thermal mapping and Not yet done
01 environment control system for 25.11.21
products storage.
Required Objective and Done
02
principles of cGMP Training.
Required Each section relevant 25.11.21 Not yet done
03 standard operating
procedures [SOPs]
Required to Release for sale tag done
05
every Batch.
06 Duly Transfer Note required. done
Required maintaining proper done
07 labeling practice of Warehouse
and FP Store.

Department : Product Development


Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

01 Required RMG Quotation sent

Required Compression machine,


02 Quotation sent
blending machine.
03 PD officer required Not yet joined

Stability chamber not functioning


04 Work order given
properly.
PD coating machine calibration
06 Not yet done
required.

Department : Administration
Doctor appointment and
01 health checkup of Work in progress
employee
Full form First aid box
02 Work in progress
required.
Health card format
Health card printing
03 prepared. Yet to be
required printed
Two sets coverall/ apron
04 for each non-management Single set available
employee required
Pharmaceutical mask, foot
05 Available now
wear required.
Required factory laundry
06 room management done
correctly
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

07 Company ID card required Work in progress

Required Key Box in


08 Work in progress
factory gate room.

List of stationary item not


10 Not yet done
found.
HO
11 Alarm system Required. approval
required
Need Cleaning Equipment
12 purchased
and Reagent.

Required List Of all


13 Not yet done
furniture and computer.

Required stationary
14 prepared
management log book.

Apron handling not done


15 Not yet done
as per SOP

16 Scrub selling SOP required Not yet prepared

Sanitation SOP & record


17 Not yet prepared
required up to date
New employee Not yet prepared
18 training/orientation SOP
required
Documentation
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Objective and principles of


19 done
cGMP training required.

Required relevant standard


20 Work in progress
operating procedures [SOPs].

Required relevant Control


21 Work in progress
forms.

Conduction of Training
22 continuing
program required.
Factory entry exit and
23 organization behavior sop Not yet prepared
& training are required.
Shoe for Management and
non-managements not
24 Work in progress
sufficient for all
departments.
Aprons for officer not
25 sufficient for all available
departments.
Dress cabinet for male &
26 female workers not Work in progress
sufficient.
Official gown & personal
27 Work in progress
attire are kept together

oncluson of the meeting: In conclusion, Honorable chairman thanked to all for their participation in the meeting and involvement towards the Management
System of Veritas Pharmaceuticals Ltd and closed the meeting wishing you all the best and good health.
___ 24.11.2021.
Veritas Pharmaceuticals Ltd
House# 77, Road # 4, Block - C, Banani, Dhaka- 1213
Tel.: +880 2 9822217-18, Fax: +880 2 9822231,
Email: [email protected], Web: www.veritaspharmabd.com
Factory: Vannara, Moucnak, Kaliakoir, Gazipur, Bangladesh

Prepared by
Md. Didarul Alam

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