R.A.K. Pharmaceuticals Pvt. Ltd.

Induction Training of Sales Team

Training
Date Training title Number of trainee
duration

20.06.09 to 25.06.09 Induction Training of Sales Team 06 days 43

18.07.09 to 23.07.09 Induction Training of Sales Team 06 days 74

16.08.09 Training of Sales Team 01 day 20

31.08.09 Training of Sales Team 01 day 87

16.09.09 Training of Sales Team 01 day 27

30.09.09 Training of Sales Team 01 day 122

15.10.09 Training of Sales Team 01 day 29

31.10.09 Training of Sales Team 01 day 150

Factory Compliance Training

Name of Training Number

Date Training title/ topic
Department duration of trainee
Quality
Assurance 28.04.09 Usage of personal protective measures 01 hour 28

26.04.09 Basic GMP requirements for production area 01 hour 12

04.01.09 Document & Protocol tracking system 01 hour 12

03.01.09 Document & Data change control procedure 01 hour 15

23.12.08 Training record 01 hour 15

23.12.08 Training of new & existing employee 01 hour 15

 Procedure of carrying out facility, utility &
22.12.08 01 hour 12
equipment
Preparation, review & approval of IQ, QA, & PQ
22.12.08 01 hour 12
protocol
Preparation, authorization, distribution, control &
20.07.08 01 hour 15
revision of standard operating procedure

31.05.09 GMP training- Health & Hygiene 02 hours 09

Orientation & GMP training program, Gowning –

07.03.09 02 hours 29
building and facilities, equipment & machineries
Orientation & GMP training program,
09.03.09 02 hours 30
documentation and line clearance

05.0309 Orientation & GMP training program 02 hours 32

05.05.09 Operation & cleaning of vacuum cleaner 02 hours 07

Dismantling & cleaning procedure of Hoong-A

blister packing machine
30.04.09 01 hour 10
And
Production Operation & cleaning of Double come blender
Procedure for transfer of Bulk tablets and capsules
18.01.09 from intermediate store to the primary packaging 01 hour 04
store

18.01.09 Disposal of waste generates from production area 01 hour 13

17.01.09 Gowning procedure for manufacturing area 01 hour 16

20.04.09 IQ & OQ of viscometer 02 hours 04

IQ & OQ of PAM automatic capsule filling

27.03.09 02 hours 05
machine
IQ & OQ of PAM automatic capsule filling
30.03.09 02 hours 05
machine, De-blistering machine

04.03.09 Automatic bottle washing machine 02 hours 04

14.03.09 IQ & OQ of automatic film coating machine 02 hours 04

03.03.09 Hand held hardness tester, Tablet disintegration 05 hours 05

tester, Tablet friability tester, Leak test apparatus
 IQ & OQ of cad mach, compression, 3Z station
18.02.09 machine and IQ & OQ of cod mach compression- 04 hours 04
27 station machine

12.02.09 Automatic blister packaging machine 04 hours 03

11.02.09 Vibro sifter 01 hour 04

10.02.09 IQ & OQ of PH meter 01 hour 04

08.02.09 PAM-Glatt fluid bed processor 02 hours 05

PMS dry granulator, Container Blender, PMS wet

31.01.09 03 hours 05
mixer & reralator

04.01.09 Thai coater 01 hour 03

Automatic tube filling & sealing machine, Vacuum

27.11.08 02 hours 03
emulsifying mixer
Operation & cleaning of polarimeter, melting
08.10.09 08 hours 03
point, karl fisher tetrator, FTIR,
Operation & cleaning of un-visible
07.10.09 spectrophotometer, centirfuse, Calibration and 08 hours 03
maintenance of digital PH meter
Product & Operation & cleaning of dissolution tester & tablet
Process 06.10.09 disintegration tester, tablet friabilily tester & tablet 08 hours 03
Development hardness tester

12.10.09 Instrument trainig 02 hours 01

Lab batch preparation and procedure for lab batch

14.03.09 01 hour 03
sample for drug administration

11.05.09 Operation & cleaning of tablet disintegration tester 01 hour 01

Operation & cleaning of muffle furnace, vacuum

26.02.09 05 hours 02
over, refract meter, visco meter
Operation & cleaning of flame photo meter, polari
25.02.09 05 hours 02
meter, tablet friality tester, tapped density tester
Sampling of packaging materials, Stock control of
03.01.09 02 hours 02
laboratory chemicals and reagents etc
12.01.09 Operation & cleaning of dissolution test apparatus, 02 hours 01
Procedure for colum washing of HPLC, Operation
of HPLC
 Change of status from Quarantine to Passed,
Control of test samples in QC lab, Assigning of lab
control number, Glassware washing & drying in
23.12.08 the lab, Release of packaging materials, 08 hours 02
Development & approval of QC test procedure,
Preparation, review & approval of raw material
specification
Operation & cleaning of leak test apparatus, Glass
22.12.08 03 hours 02
ware dryer, Drying oven, Melting point apparatus
Storage of retained sample, Change of status from
Quarantine to Rejected, Quality control equipment
21.12.08 log book, Analysis of water, Release of raw 08 hours 02
material, Preparation, review & approval of IQ/
OQ protocol for lab equipment
Operation & cleaning of tablet disintegration tester,
Dissolution test apparatus, Un-visible
20.12.08 08 hours 02
spectrophotometer, General guidance of good lab
practice

18.12.08 Sampling of raw materials 01 hour 02

Quality Control
Operation & cleaning of water bath, Digital
14.12.09 04 hour 02
calipers, Flask shaker, Sieve shaker
Preparation & issue of certificate of analysis
(COA), Sampling of rinse water and swab samples,
13.12.09 Operation & cleaning of centrifuge, Control of 08 hour 02
status label, Operation & cleaning of string hot
plate, Karl fisher tetrator, Tablet hardness

10.02.09 Operation of PH meter 02 hours 03

10.02.09 Operation of PH meter 01 hour 01

Reception and storage of flammable salvent,

03.03.09 01 hour 10
Frequency and method of cleaning of warehouse
Checking of incoming goods truck & directing it to
02.03.09 01 hour 12
factory site, and storage, issue & control labels
Warehouse
Initial reception of secondary PM by goods-
inwards, Assigning location number at warehouse,
19.01.09 Handling of damager/ breakdown container, 05 hours 06
Transfer of RM & primary PM to quarantine
storage
Planning,
Procurement & 23.11.09 Local and Foreign purchase procedure 05 hours 14
Supply
 External Management Development Training

Training Title No. Trainees Institute Training Hours

Lesson learned from 2 Drug Administration 4 hours
UNICEF Inspection
New Product 1 Marketing services & 16 hours
Development promotion
Effective Brand 2 Bdjobs 8 hours
Management

Facilities:

R.A.K. Pharmaceuticals Pvt. Ltd. has dedicated fully-fledged training centre. It has totally 3 –
fully equipped and Air-conditioned rooms with 24-hours power supply and dining facility.