The document provides an overview of Ali Asraf Sohel's in-plant training report at ACME Laboratories Ltd. It describes his visits to various departments including warehouse, production, quality assurance, quality control, and engineering. The key departments and their functions are summarized. The production process for different drug formulations like tablets, capsules, syrups, and injections are outlined. Analytical testing procedures for raw materials, packaging materials and finished products are also highlighted.

1. Presentation on: In-plan Training Report
Presentation by: ALI ASRAF SOHEL
ID:2015000300008

3. Introduction
About the ACME Laboratories Ltd.
Warehouse
Production Department
Quality Assurance Department
Quality Control Department
Engineering department
Conclusion

4. INTRODUCTION
An in-plant training is a short duration training course
which is provided to the students for help them to
correlate between theoretical knowledge and their
practical knowledge.
I have chosen ACME Laboratories Ltd for my in-plant
training which is perceived as one of the prestigious
Pharmaceutical Company in Bangladesh.

5. About the ACME Laboratories Ltd.
ACME Laboratories was established by Mr. Hamidur
Rahman Sinha in 1954 .
It is a leading company for manufacturing world-class and
top quality pharmaceutical products in Bangladesh.
We are currently producing more than 500 products in
different dosage forms covering broader therapeutic
categories
Which include anti-infective, cardiovascular, anti-diabetics,
gastrointestinal, CNS, respiratory disease, etc. among many
others.

6. I have visited General unit (GNU), Solid unit (SDU),
Cephalosporin unit(CPU), Quality assurance (QA) &
Quality control (QC) department, Production department,
warehouse division, engineering division, research &
development division.

7. Warehouse Department
Warehouse is the area where the initially received
incoming materials stored and issued for production after
necessary quality activities.
The warehouse department of the ACME Laboratories
Ltd. includes the following sections:
1. Raw materials warehouse
2. Packaging materials warehouse and
3. Finished goods warehouse

8. Warehouse Department
Besides there are some common areas which are
using by all the sections; like as-
1. Cold and cool room
2. Rejected materials room
3. Sampling area
4. Non-confirming materials room
5. Loading / unloading area
6. Marshalling area

9. Warehouse Department
Working procedures:
Standard Operating Procedures
Periodic Inventory Method
Company goals, Quality objectives and Role Profiles

10. Warehouse Department
Some important and major activities:
 Ensure the reception of right materials.
 Issue required materials for production within the
limit.
 Reception of Finished Goods from production &
timely distribution.
 Monitoring of temperature & relative humidity.
 Overall cleanliness of both materials & areas.

11. Warehouse Department
Storage Condition:
Generally four Storage Condition are maintained
according to products sensitivity. These are:
 Cold Room 2º-8ºC
 Cool Room 8º-15ºC
 Ambient Room 15º-25ºC

12. Production Division

13. Production Division
Some instrument in solid unit (SDU)
Machine Manufacturer Origin
Granulation Machine GANSONS, YENCHEN India, Taiwan
Blender PMS Thailand
Compression Machine SEGON, PTK,MANESTY,
FATTE
Korea, England,
Germany
Coating Machine YENCHEN,NEOCOTE Taiwan, India
Blistering Machine NOAK, HOONGA Germany, Korea
Capsule filling & sealing
machine
ACG pump, ROTO India

14. Production Division
Some instrument in cephalosporin unit (CPU)
Machine Manufacturer Origin
Tablet Compression Machine Cadmach India
Coating Machine Gansons India
Capsule Filling Machine Dr. Pharm China
Blister Packing Machine Buchon Korea
Integrated Powder Filling Machine Brothers India
Integrated Vial Washing Machine MACOFAR Italy
Autoclave De LAMA Italy

15. Production Division
 Some instrument in general unit (GNU)
Machine Manufacturer Origin
High speed granulator Pharmaceuticals &
Medical Supply
Ltd.
Thailand
Planetary mixture
Fluid bed dryer Sapphire Machines India
Coating Machine Gansons India
Compression machine SEGON,
PTK,MANESTY
Korea, England,

16. Production Division
The production unit sends requisition for the raw material
and packaging material according to the BMR and BPR
arrived from QA department.
The warehouse sends the required material to the
production division via pass box.
After dispensing, the materials are kept in post dispensing
area.
The production process depends on the type of dosage
form.

17. Production Division
For tablet manufacturing 3 processes can be
used:
1. Direct Compression
2. Dry Granulation
3. Wet Granulation

18. Direct compression method
API & direct compression enhancer excipients
measurement
Mixing
Compression
Blistering
Packaging

19. Wet Granulation
Material rechecking
Sieving
Accurate weighing of active ingredients & necessary
additives
Dry Mixing of materials by RMG (Rapid mixing
granulator)
Moistening with paste preparation

20. Wet Mixing
Wet Milling
Drying (FBD)
Final (dry) Milling
Lubrication

21. Compression
Tablets
Coating if needed

22. Dry Granulation
Material rechecking
Sieving
• Accurate weighing of active ingredients & necessary
additives
Mixing
Slugging

23. Crushing
Blending
Compression
Tablet
(Coating if needed)

24. Problems during compression
Tablet
Problems
Mottling
Sticking
Weight
variation Picking
Cracking
Chipping
Lamination

25. Coating
Materials used for film coating:
Hydroxy propyl methyl cellulose
Polyethylene glycol
Methylene chloride.

26. Materials used for enteric coating:
Cellulose acetate phthalate.
Hydroxy propyl methyl cellulose phthalate
Diethyl phthalate

27. ACME Laboratories Drug

28. For capsule manufacturing Process:
Developing and preparing the formulation and selecting the size
capsule.
The raw materials (active and excipients) are blended
Fill the capsule shells.
Capsule sealing
Cleaning and polishing the filled capsules.

29. Packaging
Primary Packaging: When the product contents are
directly in contact with the packaging materials then
the packaging is called Primary Packaging.
Examples:
1. Strip Packaging
2. Blister Packaging

30. Secondary Packaging: When the product contents are
directly not in touched with the packaging materials then
the packaging is called Secondary Packaging.
It is three types:
1. Inner Carton
2. Master Carton
3. Shipper’s Carton

31. Purpose of Packaging:
To increase the acceptability of the drug
To increase the stability of the drug
To minimize the transport/shipping hazards
To improve patients compliance
To improve the pharmaceutical elegance by use
of special color or contrasting printing

32. Packaging Information:
Following Information are generally provide by primary
packaging:
1. Product name
2. Materials name.
3. Batch size & batch number.
4. Manufacturing date and expiry date.
5. Packaging systems.
6. Logo of the company.
7. DAR No. of the product etc.

33. Materials used in blister packaging:
 PVC (Polyvinyl chloride)
Polyethylene laminated aluminum foil.
 PVDC
Alu-Alu foil.

34. Liquid & Semisolid Unit

35. Manufacturing Process of Syrup:
Collection of required amount of water & sugar
When temperature goes to 100⁰ C preservatives are added
After 20 minutes, cooling starts
Addition of wetting agent when temperature below 45⁰ C
Addition of ingredient

36. Addition of co-solvent, buffering agent
Addition of sweetening agent
Addition of color & flavor
Volume adjustment
Filling & sealing
Packaging

37. Manufacturing process of suppositories:
Compounding vessel
Melting 50⁰C
Overnight cooling (40⁰C)
Compounding vessel (40⁰C)
Addition of active ingredient

38. Sieving 40 mesh
Per foil 1.15 g liquid products filling
Cutting
Packaging

39. Injection
The ACME Laboratories Ltd. has separate for injectable which
consists of several sub units
Compounding area
Aseptic rooms for filling and sealing
Sterilization room (autoclaving and terminal sterilization)
Vials and ampoules washing and sterilizing room
Packaging and packing room.

40. Aseptic condition:
Room temperature: 20-25oC
Room humidity : >50%
Pressure difference: 10-15pascle
Clothes, utensils and removable parts of the machine:
autoclave at 121oC for 15

41. Manufacturing process of injectable products:
Empty ampoule washing
Sterilization & cooling
Solution preparation
Filtration
Visual inspection

42. Terminal sterilization
Filling & Sealing
Blister sealing Packing

43. Quality Assurance Department
 Quality assurance is the sum total of the organized arrangements
made with the object of
QA = Product design + GMP + QC + Quality goal activities.
QA has 3 major sections:
1. Quality compliance
2. GMP Implementation
3. Process validation & Qualification

44. Quality Compliance:
 Document control & management.
Change control & monitoring.
Environmental monitoring.
Customer compliance.
Risk assessment.
Change control.
Batch Release.

45. GMPAssurance:
CAPA.
Deviation.
Training.
IPQA.
Internal Audit.

46. Validation:
Process Validation.
Cleaning validation.
Facility.

47. Documentation Control & Management:
They approve, control, distribute, maintain archive
and ensure superseding of documents. They deal
with SOP, BMR. They are responsible for the
change control system.

48. Change Control System:
If any type of change is needed at any stage of
production process, facility, utility or material
usages, change control is must.
The corresponding person or department must
have to submit written request as a change control
form to QA for approval for the change.

49. CAPA:
CAPA stands for Corrective and Preventive Actions. If
any change is needed in any system or deviation
happens, QA analyzer team points out the problems &
provides a report as CAPA. The changes are done
according to CAPA.
CAPA is also issued for development purpose.

50. Validation:
Process Validation:
1. Prospective
2. Retrospective.
3. Concurrent
4. Re-validation

51. Cleaning Validation:
Cleaning validation is done for sharing equipment,
not for dedicated ones. 2 types of cleaning is done
in pharmaceutical plants:
1. Type A.
2. Type B.

52. Type A cleaning is done with suitable disinfectants
& cleaning agents when different product is to be
manufactured or processed on same equipment.
Type B cleaning is done with PW when same
product of different batch is to be prepared.

53. QUALITY CONTROL
Quality control (QC) is a procedure or set of procedures
intended to ensure that a manufactured product or
performed service adheres to a defined set of quality
criteria or meets there requirements of the client or
customer.

54. Major responsibilities of QC:
They collect raw materials from ware house along
with material name, batch no, batch size.
They perform various tests of raw materials and keep
records and provide the analytical record sheet to the
concerned departments which are later included with
BMR.

55. They ensure precision and accuracy of all testing
method.
They calibrate and standardize laboratory
instruments.
They follow BP, USP, NF to perform various
analytical tests as specified.

56. GMP requirements for the Quality Control Areas:
Normally QC laboratories should be separated from the
production areas.
Sufficient space should be given to avoid the mix-up and
cross contamination. There should be adequate suitable
storage space for samples and records.

57. Separate rooms may be necessary to protect the
sensitive instruments from the vibration, electrical
interference, humidity etc.
Special requirements are needed in laboratories
handling particular substances such as biological or
radioactive samples

58. The QC department has 6 sections
1. Raw material analysis
2. Packaging material analysis
3. Finished product analysis
4. Calibration
5. Microbiology test
6. Stability testing

59. Raw material analysis:
Solid Raw materials:
Identification
% of LOD
Sulfated Ash
Bulk density
Heavy Metal testing
Impurities
Melting point
Bulk density
Specific Optical
Rotation
 Water content test

60. Liquid Raw Materials:
Maximum tests for solid
Refractive Index
pH
Weight per ml
Viscosity

61. Finished product analysis
Solid Preparation:
 Description
 Dissolution &
Disintegration time
 Weight Variation
 Assay
Content uniformity
Hardness
 Thickness
 Friability test
Average weight

62. Liquid Preparation:
Appearance
Suspendibility
Potency
Weight per ml
Microbiological Limit Test
pH

63. Tests for WFI:
Contents of vial/bottle
Sterility test
pH value test
Ammonia test
Nitrates test
Chlorides test
Sulphate test

64. Acidity/alkalinity test
Oxydizable substances test
Heavy metals test
Ca & Mg test
Residue on evaporation
Conductivity test
Water content

65. Calibration:
To make sure that the readings of equipment or
instruments are consistent with other
measurements and display the correct readings
every single time
To determine the accuracy, precision, reliability
and deviation of the measurements produced by all
the instruments

66.  To establish the reliability of the instrument being used
and whether it can be trusted to deliver repeatable
results each time
 To map the ‘drift’ as documented. Instruments have a
tendency to produce inaccurate measurements over a
period of time, following repeated use.
Ensuring that the industry standards, quality assurance
benchmarks such as current good manufacturing
practice (cGMP) and government regulations are
adhered to.

67. Microbiology Section
 Water bath,Clifton
Liquid born particle counter,APSS-2000
Double door autoclave
Universal oven, Memmert, Germany Incubator,
Memmert, Germany
Laminar flow cabinet, Air tech, Malaysia
 LAL analyzer, Biotek, US.

68. stability test
This subsection of QC department performs the stability
test on both raw and finished products.
The purpose of stability testing is to provide evidence on
how the quality of an active pharmaceutical ingredient or
medicinal product varies with time under the influence of a
variety of environmental factors such as temperature,
humidity, and light, and to establish a retest period for the
active pharmaceutical ingredient or a shelf life for the
medicinal product and recommended storage conditions.

69. Four climatic zones can be distinguished for the purpose
of world wide.
ICH Stability Zones
Zone Type of climate Temperature Humidity
Zone II Temperate zone 21°C ± 2°C. RH 45% ± 5%
Zone II Mediterranean/subtro
pical zone
25°C ± 2°C. RH 60% ± 5%
Zone III Hot dry zone 30°C ± 2°C. RH 35% ± 5%
Zone IV Hot humid/tropical
zone
30°C ± 2°C. RH 65% ± 5%

70. INSTRUMENTATION OF QUALITY CONTROL
SECTION
INSTRUMENTS ORIGIN FUNCTION
HPLC Waters(USA)
Shimadzu(Japan)
Dionex(Germany)
PerkinElmer(USA)
For separation, identification
& assay
Gas Chromatography(GC) Shimadzu(Japan) Product identification,
separation & assay
UV-Visible
Spectrophotometer
Shimadzu(Japan) Product identification, assay
Atomic Absorption
Spectrophotometer (AAS)
Shimadzu(Japan) For identification/ detection of
metal (elemental analysis).
Dissolution Testing
Apparatus
Erweka(Germany)
Hanson (USA)
Dissolution rate
determination.

71. INSTRUMENTS ORIGIN FUNCTION
Disintegration Testing Erweka (Germany),
Logan(USA),
Phamatest(Germany)
Disintegration time
determination
pH Meter Mettler-Toledo
(Switzerland),
Metrohm(Switzerland)
Disintegration of
moisture& bound
water.
Potentiometer Titrator Metrohm,
(Switzerland)
Used for titration &
voltage change, pH
Change.
Visometer Brookfied(USA) Determination of
Viscosity

72. Engineering Department
The Engineering department divided into two sections
Project
management
Operation
Maintenance
• New building design
• machine setup
• Utility
• Production Machine

73. HVAC SYSTEM
This section maintains the required environment at
different area. Control environmental conditions
like temperature, humidity, air bone particle
number, air pressure are controlled by HVAC
system.

74. The HVAC system has three functions:
Air
conditioning

75. HVAC consists of different parts such as
Air handling unit (AHU):
Ducts
Chiller
Heater
Dehumidifier

76. CONCLUSION
In-plant training for a pharmacy student, a learning
combination of theory and practice is an invaluable
asset which helps in understanding the core meaning of
pharmacy by way of the first-stand experience.
The Subject like pharmacy demands practical
knowledge of its own field.
Thus industrial training program is one of the most
important parts of a student studying in a subject like a
pharmacy.