Beximco pharmaceuticals LTD. in plant training report

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Executive Summary:

Beximco today is a symbol- a state of health, happiness and quality of life. But its journey to the growth and prosperity has been no bed of roses. BPL’s history is one of innovation and adventure, of risks taken and bold decisions made towards a noble purpose-building a healthier tomorrow where citizens like us can live longer, happier, and better.

Beximco Pharmaceuticals Ltd. or BPL, the leading pharmaceutical company of

Bangladesh and a member of the BEXIMCO Group was founded in 1976. Since then it has been producing produces pharmaceutical specialties of uncompromising quality in its several world-class pharmaceutical production units following current Good Manufacturing Practice (cGMP) as required by the World Health Organization (WHO).

Beximco Pharmaceuticals Ltd. has products of different therapeutic classes, each of which occupies a prominent position in the market and the heart of people. Life seems static without Napa and Neoceptin, the prime products of BPL. More than 10% of country’s total medicine need is supplied by Beximco Pharma where separate solid production unit and Liquid/Cream/Ointment Production unit manufactures comprehensive range of formulations, which come in tablet, capsule, powder, liquid, cream, suppository, nasal spray and others covering all the major therapeutic groups.

The factory at Auspara, Tongi, Gazipur comprises mainly of seven departments which are

HRD (Human Resource Department)

PPIC (Production Planning & Inventory Control)



Quality Assurance and Control Department

Engineering Department

Accounts, Finance and Informatics etc.

In each and every department of this plant all the personnel work very hard to produce products of the best quality and the least price. This is why Beximco has acquired a crown of success in such a short period.

Aims of In-Plant training:

To complete graduation we have to pursue several courses of Pharmacy for a period of four years in our university. We study a lot of subjects on various essential matters, but can not relate their implications in pharmaceutical industries. So our main objective behind taking this in-plant training is:-

To actually see how a pharmaceutical company runs and understand all the processes, equipment, regulations and controls involved in the production of every kind of dosage form.

To feel how different departments are interlinked and to understand the role, functions and responsibilities of each department in the factory.

To update ourselves with modern and sophisticated machineries, dosage forms, and concepts.

To practically see the application of GMP or cGMP in the plant.

To learn about various trouble shooting in manufacturing being performed first hand

To bring anew forgotten concepts

16.06.09 : Introduction to the plant

On the first day of our training we arrived at BPL factory, Tongi on 7:45 am and the security supervisor at the reception informed the HR department of our arrival. At 9:00 am we were taken inside to a conference room and there we met the head of HR.

Mr. Sharif introduced himself, saw our papers and then handed us a training schedule which contained the date and time on which training at a particular department will take place and to whom the students should report each day.

He mentioned the dress-code for office and gave a brief idea of Human Resource Department of Beximco Pharma. From him we understood that, BPL human resource is guided by the principle “Investing on human capital maximizes the potential of financial and commercial assets”. To achieve the full potential of its commercial and financial assets Beximco Pharma comprises of a number of young and highly motivated executives who reflect a diversity of background, experience and perspective. Their skills and intellect for capitalizing on emerging market opportunities and evolving customer needs, a bias for innovation and creativity, an appetite for prudent risk taking, and a strong sense of what needs to be done to grow and strengthen the business are key components in the successful implementation of Beximco Pharma’s sound business strategy.

Besides other important functions one of the major tasks of HR department of BPL is to prepare & arrange In-plant training program for students of different universities.

From time to time the HR head corresponds with the trainee students and takes notice of their progress. If any problem is faced during the length of training the HR head is informed and he handles it. He also notes down their daily attendance.

Major functions of HR department includes:-

Recruitment of personnel, maintain & update personnel files

Co-ordinate & monitor ‘Performance Appraisal’ of plant employees

To assess the training needs of the personnel in light with the cGMP& other related HRD issues and arrange ‘induction training program’ for new employees.

Ensure proper implementation of labor laws applicable to factory workers & employees.

Implement Disciplinary actions, including suspensions, punishment & termination, when required.

Maintain liaison with Government Regulatory bodies

Ensure safety of all employee & company assets

Monitor leaves of plant employees

Handle external visitors & arrange all necessary uniforms & other accessories

Supervise transport pool (distribution, repair, maintenance), canteen management & food arrangement

17.06.09: Production planning

On the very next day we came to know the basics of Production Planning. Every production or manufacturing company should follow a complete and precise production plan in order to ensure sound and uninterrupted production of medicine. The production planning department in BPL is concerned with the synchronization of the availability of the raw and packaging materials with man power, machine capacity, and time of delivery of the product depending on the market demand .

Functions of production planning department:-

Issue of BPR and BMR– Batch Packaging Record (BPR) and Batch Manufacturing Record (BMR) is issued every month by the planning department according to the production plan. If any change is required planning will consult with product development for its correction. The product standard is always maintained even in case of short batch but then batch size is reduced. So a single BPR/BMR is issued by production planning department that is for one time use only.

Maintain the monthly plan- Amonthly plan is based on the demand of the marketand according to itproduction planning department suggest production department to manufacture the product.

Ensure the availability of raw and packaging materials- : Production planning department also arranges for the delivery of all types of raw and packing materials by consulting with head office so thatproduction runs smoothly.

Arrange physician’s sample:-Production department will separate physician’s samples from bulk production following the instructions of panning department. . In this case, samples are prepared at least one month prior to dispensing and are dispensed in catch corners. From manufacturing to packaging, PPD have to pay extra concern for this type of sample.

Arrange products for International market:- PPD will arrange and supply the products to the global market. After receiving information via email, they take necessary actions to meet that demand for export purpose.

Co-ordinate all sections: – Planning department co-ordinates all sections to give the highest production at minimum cost and time.

Compare man hour and achievements:– This is done to know the actual efficiency of man and machine.

Submission of monthly report:- PPD submits monthly production report to ED, Works for analysis at the end of each month.

Keep daily production reports & other important documents:– PPD preserves every paper deals of any products including acceptance/ rejection paper of raw and packaging materials, order paper, delivery report, invoices, BMR etc.

18.06.09: Warehouse

On the third day of our training we went to visit the BPL warehouse. We found that the chief difference between a normal warehouse and a pharmaceutical warehouse is that the latter stores raw material, packaging material and finished goods for human consumption and sorequire specified preservation techniques, place of storage, temperature, atmosphere, humidity etc. A BPL warehouse with about 1300 types of packaging materials and 500 types of raw materials has strictly maintained SOPs and is strongly guided by GMP.

The different areas we saw in the warehouse are:

Quarantine area: After receiving raw and packaging materials are kept here for QA approval

QC sampling area: This basically consists of sampling booths where the environment (temperature, humidity and pressure) is strictly controlled and the sampling is done by QC officer under laminar air flow and HEPA filter

Released area: QC approved raw and packaging materials are generally stored in the central place of warehouse with great safety and controlled temperature and controlled humidity.

Rejected area: QC rejected raw materials, packaging materials and finished goods are stored here with great care. The rejected area is located at one corner of the warehouse in a separate room, where entry is strictly regulated

In–process area: Materials dispensed for manufacturing are kept in this area.

Finished products area: Fully competed and ready-for- use products are stored here until delivery.

Special area: Area or room for storing heat and light sensitive materials like colors, vitamins, poisonous materials and flammable materials. There are 3 cold rooms (temperature below 25º).

Fig 1: Portion of a warehouse

Two types of job is found in a typical warehouse

Routine Jobs

Periodic Jobs

Routine jobs of warehouse personnel involves:-

  1. Receiving and unloading the materials (raw & packaging) at receiving bay.
  2. Making the containers completely dust-free on arrival
  3. Matching the invoice with the containers received and checking them for any visible signs of damage
  4. Weighing the containers and verifying the invoice
  5. Officially receiving the materials and preparing the MRR (material receiving report)
  6. Informing the QC department and assisting the QC department personnel with sampling
  7. Appropriately labeling the containers with sample, quarantine, release or reject tags
  8. Placing the containers in the in-process area of warehouse so that it is ready for issue and can be sent to the production department
  9. Ensuring the containers are dispensed in an appropriate manner and on a FIFO (First-In-First-Out) basis
  10. Monitoring the inventory levels of each material stored in the warehouse
  11. Ensuring that the finished products are dispatched with the required documentation

Periodic jobs of warehouse personnel involves:-

  1. Export-The ware house is responsible for obtaining Export Permission (EP) order for products that are to be exported. It is also considered as the final check point where the containers are weighed and matched with the invoices before exporting so that any discrepancies can be discovered
  2. Pricing: Incase of a change in price the warehouse is responsible for obtaining approvals from customs. The appropriate documents are sent with samples of the product.
  3. To carry out efficient recall of a product when and if required and in the established procedure.
  4. Audits: To successfully face an audit, it is necessary for the warehouse to maintain the logbooks (for weighing, cleaning, temperature, sampling booth, daily calibrations, etc) as a proof that SOPs are followed within the warehouse premises.
  5. Inventory management: The BPL warehouse is responsible for continuously updating its inventory. The total inventory of materials is checked periodically and quantities of materials are either written on or off depending on whether it is excess or short respectively.


We found the cascade labeling of materials in the warehouse most interesting. There are four kinds of labels.

Quarantine: Materials which has been received but are still not been sampled by the QC department are labelled with this sticker. It is usually yellow in color

Sample: Materials which are undergoing sampling by the QC dept. are labelled with this sticker over the Quarantine one

Released: Materials which proved satisfactory by the QC tests are then labelled with this sticker. The released sticker is stuck on such a way over the sampled one that the Sampling information is not visible. . It is usually green in color

Reject: If any material fails in the QC tests then it is labelled with a reject sticker. It is usually red in color.

Fig 2: Cascade labeling


Sampling: The process of taking a small portion from a lot for test and analysis to show the quality of the whole lot. The purpose of sampling and subsequent testing is to provide an effective check on the quality of the product or substances being processed.

Sampling quantity: Sampling quantity should be the double of one complete test.

Lot: A batch or number of batches in a consignment.

Batch: A quantity of the product or material that is processed in one run following manufacturing USP.

Campaign: A campaign means no. of batches manufactured without any interruption or product change.

Handling: The term handling means checking according to invoice/ challan and other documents during receiving of the materials.

Preservation: It means the materials are stored in different conditions according to its nature of stability i.e. to maintain a specific temperature and relative humidity.

Dispensing: It means the materials are supplied to the production areas by weighing according to the proper document and release it from the RM store.

Quarantine: The term quarantine means the materials is not ready for use and it is under test after receiving. So a quarantine label is attached to the container.

FIFO: The term FIFO stands for First in First Out.

Re-Test: The term re-test means the samples are needed to be repeated analysis for identification according to previous documentation and it has to be done either 3/6/12 months.

Materials sampling plan:

The material sampling plan is done on the basis of FIFO system i.e. First in First Out. For active ingredients, every container and for excipient, (Ön+1) containers are sampled (where n = total no. of the containers.)


To keep warehouse free from rats and insect traps and pesticides bare used respectively

To protect the materials from dust double-door system is used

Raw and packaging materials are easily identified by index which has different code for different area

Packaging material are stacked according to alphabetical order

Beximco Pharmaceutical Ltd has two other similar warehouses, one in Pharmatech and another in the infusion department.

21.06.09 and 22.06.09: Product Development

After the weekend we made a 2-days visit to the Product Development department of Beximco. There Suronjit Sir was kind enough to explain the role of PD.

The basic functions of Product Development department are:-

Formulation of a new product

Reformulation of exiting product

Troubleshooting related to manufacturing

Export related work


Product development flow sheet:

Selection of new product for product development

Preformulation study

Prototype/formulation feasibility trial batch

Analytical method development and preparation of STP

Pre-scale up batch and stability batch

Scale up batch

Stability study

Preparation of stability study report

Determination of product shelf life

Determination of product data sheet

Preparation of BMR and BPR

Pilot cum commercial batch production

Preformulation study:

Preformulation study of the active ingredient and excipient includes

– Chemical activity

– Solubility

– Particle size

– Compatibility

– Boiling point, melting point

– Moisture content

– Safety etc

Formulation feasibility:

After submitting of recipe to drugs administration that contains the following

a) Pharmacological part

– Strength

– Dosage form

– Contraindication

– Indication

– Description

– Precaution

– Side effect

– M.R.P

– Indication

b) Technical part

– Batch formula

– Manufacturing instructions

– Control data

Through trial-and-error method many formulations are checked and counter checked to find one that fits economically and technologically. This process to discover the most suitable formulation is Formulation feasibility.

Analytical method development and preparation of STP:

The active drug and the excipients and the final product must undergo a chain of analytical tests which would confirm their identity, purity, stability and other related parameters so according to USP,BP or for a completely new product methods of analysis are designed and developed and a standard test procedure is prepared and followed.

An analytical assay method validation report contains

Product name


Protocol no.

Method no.

Issue date

Date of next revision

Some confusing terms:

Pre-scale up batch: Batch size considering the minimum machine capacity of the production department preferably 10 times larger than the trial batch.

Scale up batch: If the pre-scale up batch is not enough to meet the demand then 10 times bigger batch is produced

Stability batch: The batch which undergoes stability testing at temperature and humidity mentioned in the protocol.

Pilot batch: The stability batch which is not discarded but marketed with a commercial batch.

Commercial batch: The batch which is manufactured according to market demand finally.

A stability test report contains





Microbiological test

Determination of product shelf-life:

There is two kind of stability testing

Real time with temperature 300c+2 and relative humidity 65%+5

Accelerated stability with temperature 400c+2 and relative humidity 75%+5

A product is kept for 1, 3, 6, 9,12, 24 months in the stability test chamber and if it is alright for 1 year in real time and 6 months in accelerated then 2 years expiry date can be given.

A stability study report has the following columns

Raw material Specification Batch no. % Quantity/

unit dose



Weighed by Checked


Product data sheet:

The following are found in a product data sheet

Product name: Label claim:

Pack size: Batch size:

DAR no.: Date:

Batch weight: Product code:

Revision no.

ID Code Name of material to be used Speci


Unit of measure Overage Qty per tablet Qty per batch
Raw material



Enteric coating material
Colour coating material

Polishing material

Packaging material



BMR preparation:

  1. A BMR usually contains the following information
  2. Equipments
  3. Dispensing of raw materials/Manufacturing formula
  4. Receiving of dispensed raw material
  5. Manufacturing process
  6. Deviation record
  7. Production certification

Reformulation of exiting product:


a) Increase the quality of the product.

b) Prevent any type of problem existing in the product.

c) To save time and cost.

d) To increase patient acceptance.

Existing formulations are rearranged e.g changing a flavour or adding another vehicle or increasing/ decreasing the quantity of the active or additives.

Instrumentation of the PD Department:

Formulation Section

  1. Stirrer
  2. Electronic balance (with balance )
  3. Tap density tester (USP)
  4. High Speed Mixer Granulator
  5. Fluid Bed Dryer
  6. Multimill
  7. Moisture Analyzer
  8. Compression machine (16 stations)
  9. Film coating machine
  10. Watson pump
  11. Friability Tester
  12. Humidity control Oven

(For accelerated stability test : Temp.:40ºC, RH:65%)

  1. Humidity Control Oven

(For intermediate stability test: Temp.:30ºC,RH:65%)

Anaytical section:

  1. Erweka Double Station Disintegration
  2. Erweka Dissolution tester
  3. Shimadzu HPLC (Auto Injector UV-Vis Detector)
  4. Shimadzu HPLC (Auto Injector Diode Array Detector)
  5. Hanna Ph meter
  6. Membrane filter (0.45 micron)

7. Newtronic stability oven

8. Memmert oven

9. Sonicator

23.06.09 and 24.06.09: Solid Dosage Formulation

After completing the product development department we had a 2-days tour of the solid production unit. In Beximco it is the biggest unit from which comes 70% of the total turnover per year.

It is basically divided into

Solid Unit

Manufacturing area Packaging area

Granulation Compression Coating Encapsulation Blister Strip Powder Bottle

unit unit unit unit filling filling

Manufacturing Area:

The three common methods to make tablets are

Wet granulation

Dry granulation

Direct compression

Granulation Unit Miller Granulator (Mixer) Dryer Capacity Vaccum Product observed
01 GANSONS Multi-mill (India) GANSONS Planetary Mixer


SAPPHIRE Fluidized bed Dryer 60 kg BELLE VILLE Vac-U-Max (U.S.A) ——–
02 GANSONS Multi-mill (India) GANSONS Planetary Mixer


SOLACE Fluidized bed Dryer 120 kg BELLE VILLE Vac-U-Max (U.S.A) Tofen


03 HSMG (High speed mixer Granulator) SAPPHIRE Fluidized bed Dryer 150 kg Napa Extra
04 GANSONS Multi-mill (India) HSMG


SOLACE Fluidized bed Dryer 250 kg BELLE VILLE Vac-U-Max (U.S.A) Napa Extra

Flow chart of wet granulation:

Raw materials weighing Blending Wet mass Drying Milling

Packing Coating Compression Blending Sieving

Wet granulation procedure for Napa extra:

Step 1: Granulating solution is prepared with povidone and water in a SS vessel

Step 2: Paracetamol and caffeine, pregelatinized starch, sodium starch glycolate, magnesium stearate, stearic acid is passed through 28 mesh and blended in high speed mixer and granulator.

Step 3: Granulating solution is added to dry blend for wet blending.

Step 4: The blend is semi dried in Fluid Bed Drier

Step 6: Semi dried granules is passed through multi-mill fitted with 9.35mm screen

Step 7: The dried granules are passed through multi-mill fitted with 2.4mm screen and transferred into Tote-bin

Step 8: LOD of crushed granules are checked.

Flow chart of dry granulation:

Raw materials weighing Dry mixing in V-blend Compaction by roller


Sieving Milling Slugging

Final mixing (lubrication) Compression

Flow chart of direct compression:

Raw materials weighing Drying Crushing Sieving

Packing Coating Compression Blending

Compression area:

1. Compression unit # 1:

Name of the machine: MANESTY

Model of the punch: D type

Name of the producer: MANESTY Machineries Ltd. Liverpool, England.

No of stations: 16

Capacity: 1500 tablets/hour

This is very old model tablet compression machine but it is the first machine by which Beximco started.

2. Compression unit # 2:

Name of the machine: MANESTY

Model of the punch: B type

Name of the producer: MANESTY Machineries Ltd. Liverpool, England.

No. of stations: 35

Capacity: 240000tablets /hour

3. Compression unit # 3:

Name of the machine: MANESTY

Model of the punch: B type

Name of the producer: MANESTY Machineries Ltd. Liverpool, England.

No. of stations: 35

Capacity: 240000 tablets /hour

4. Compression unit # 4:

Name of the machine: Fette-1200

Model of the punch: BB type

Name of the producer: Germany

No. of stations: 30

Capacity: 220000 tablets /hour

5. Compression unit # 5:

Name of the machine: Fette-3100

Model of the punch: BB type

Name of the producer: Germany

No. of stations: 55

Capacity: 594000 tablets / hour

6. Compression unit # 6:

Name of the machine: MANESTY

Model of the punch: B type

Name of the producer: MANESTY Machineries Ltd. Liverpool, England.

No. of stations: 35

Capacity: 70000 tablets / hour

7. Compression unit #7:

Name of the machine: SEJONG

Model of the punch: B type

Name of the producer: South Korea

No. of stations: 45

Capacity: 494000 tablets /hour

Coating area:

Coating is mainly done to improve product elegance; to mask unpleasant taste,odour; to control drug release from tablet; to provide physical and chemical protection.

Coatings usually done in solid section are:


Sugar coating Film coating Enteric coating

Aqueous coating Organic coating

Steps of Aqueous FILM coating:

Core Drying

Spray of Coating Solution at specific pan speed, temperature and pump speed


Steps of Sugar coating:

Core drying

Seal coating (Opagloss NA 7150)

Sub coating

(Coating materials: Acacia, gelatin, talc, titanium oxide, sugar)


(Colourting materials: Opulux As-22937[yellow],purified water , sugar)


(e.g. Polishing materials: Opagloss-6000[white])

Machines used for coating:

Unit Machine name Origin Capacity (Kg) No.of guns
1 Manesty Accela Cota 150 England 150 2
2 Manesty Accela Cota 350 A England 350 2
3 Manesty Accela Cota 350 B England 350 2
4 Sejong Pharmatech

(Sugar coating)

Korea 350 2

Capsule Filling Unit:

There is a highly sophisticated capsule-filling machine in the solid department of BPL. During capsule filling, room temperature and humidity (<40%) must be strictly controlled, because capsule shells are highly sensitive to moisture as well as some drugs (e.g. Ranitidine). Even though, after filling of capsules by mainly granules or pellets, finished capsules are transferred from the filling room to the packaging room by plastic drums that are covered by silica gel that acts as moisture absorbent.

Name of the machine Source Stations Feature
Automatic Capsule Filling Machine


(MG Futura)

Italy 16 Max. 50000


Capsule manufacturing procedure:

Sieving of raw material Mixing Compaction

Blister pack Polishing Blister pack

Fig 3: Capsule filing machine

Packaging Area:

Packaging can be defined as an economical means of providing presentation, protection, identification / information, containment, convenience, and compliance for a product during storage, carriage, display and use until the product is used or administered.

Types of Packaging:

1. Blister Packaging

2. Strip Packaging

Primary packaging materials:

§ ALU- ALU types

§ ALU- PVC type

§ ALU – PVDC type

Secondary Packaging Materials are:

l Inner carton

l Leaflet

Blister Packaging Area:

Packaging Unit Machine Supplier/Manufacturer
Blister 085 KlocknerHansel Germany
Blister 042 Otto-Hansel Germany
Blister 043 Otto-Hansel Germany
Blister 074 Klockner -Hansel Germany
Blister Elmac Elmac India
Blister Pampac Pampac India
Blister Hoong A Hoong A Korea

Strip Packaging Area:

Strip Packaging Gansons Strip Packaging machine-1 India
Hamson Strip Packaging machine-2 India

Problems that may arise during packaging are :

  1. Empty pocket
  2. No pocket
  3. Damage of tablet/capsule
  4. Printing mistake
  5. Unclear printing

Blister packaging:

Foil soften by hot plate

Temp. 125-145°C

PVC sheet
Heating plate

Pressed by two plates simultaneously (upper plate temp. 160-180°C for PVC & lower plate is cold
Desired blister pack
Passed through cutter

Fig 4: Blister packaging machine

Strip packaging:

Printing Area:

To print:

Batch No.

Mfg. date

Expiry date

Printing machine:

Machine Name Origin
Semi-automatic Printing machines-


KK & KK-2 Printing machine



Fig 5: Primary and secondary packaging

25.06.09 and 28.06.09: Liquid dosage formulation

As we visited the LCO unit we found that Liquid manufacturing department of Beximco Pharmaceuticals Limited (BPL) is an important part of the production department. This liquid department mainly manufactures various types of syrups, suspensions, pediatric drops, nasal spray, cream, ointment, gels and suppositories etc. The numbers of liquid products that are manufactured in the LCO department of BPL are 85.


l Line1- Non antacid syrup & suspension manufacturing area.

l Line 2- Antacid suspension manufacturing area.

l Line 3– Small volume preparation or nasal spray manufacturing area.

l Line 4– Cream, ointment & gel manufacturing area.

l OLSF– Oral Liquid Suppository Facility

Production of syrup :




Bottle filling




Fig 6: Mixing vessel

Production of Antacid suspension:



Bottle filling Packaging

Sealing Labeling

Production of cream:

Production of ointment:

Base (which is liquefied by heat)

Addition of Active ingredient

Homogenization (75-800c)

Congealing (below 400c)


Storage Filling Packing

Production of suppository:

Manufacturing Vessel Melting Cooling (400C)

Manufacturing vessel tank Sieving with 60 mesh screen Addition of active

Filling Congealing (20-210C) Sealing and batch coding

15 minutes

Packing Cutting

Fig 7: Suppository filling and sealing machine

Line1, Line 2, Line 3:

Name Capacity
1.Manufacturing vessel 3000L & 5000L
2.Storage vessel & agitator 3000l & 5000L
3.Inline mixer & transfer pump 400L , 440 psi
4.Millipore filtering machine 5000L/hr
5. Vessel with fluid agitator 1000L
6.Bottle filling machine

( Automatic liquid filling & sealing machine)

85-100 bottles/min
7.Labelling machine
Name Capacity
8.Cap sealing machine 28-32 bottles/min
9.Self adhesive labeling machine 110bottles/min
10.Fluid Agitator 250rpm
11.Liquid Transfer Pump 1000L/hr
12. Liquid mixer 450L
13.Liquid Filling Machine 30-35 bottles/min
14.Laminar Air Flow Cabinet (used to control bacteria in the filling area)
15.Filtering machine 1000L/hr

Line 04: Cream, Ointment & Gel production Area

Name Capacity
1.Planetary mixer 70L
2.Colloid mill 250Kg/hr
3.General purpose mixing machine 100L
4.Automatic tube filling & sealing machine 25-55 tube/min

Line 05: Suppository Unit

Name Capacity
1.Manufacturing Vessel 100L
2.Filling & Sealing machine 5000suppo./hr
3.Leak Test Apparatus
4.Weight balance machine Max.1500gm Min. 0.01gm

Line 06: Oral Liquid Line

Only syrup of 50 ml, 60ml & 100 ml

Name Capacity
1.Manufacturing Vessel 5000L
2.Storage Vessel & Agitator 5000L
3.Milipore Filter 5000L/hr.
4.Auto filling , sealing machine (8 stations) 6000 bottles/hr.
5.Bottle washing & labeling machine 102 bottles/min.

Over Printing Area:

Name Model Origin Capacity
1.Semi-automatic over printing machine HAPA-L Switzerland 4000prints/hr
2.Automatic over printing machine KK-610 Taiwan 4000prints/hr
3.Automatic over printing machine KK -560 Taiwan 4000prints/hr
4.Automatic over printing machine KK – 550 Taiwan 4000prints/hr
5.Semiautomatic printer SAP-L Bangladesh 1500prints/hr
6.Semiautomatic printer SAP-L Bangladesh 1500prints/hr
7.Automatic over printing machine KK-570 Taiwan 4000prints/hr

Fig 8: Over printing machine

29.06.09 and 30.06.09: Quality Control Department

At BPL, total quality control refers to the process of producing a perfect product by

a series of measures. BPL’s Q.C. lab is well equipped with most modern and sophisticated equipment and In every step, from the procurement of raw materials to the manufacturing of finished products, the latest World Health Organization (WHO) approved current Good Manufacturing Practices (cGMP) are being followed. There are written Standard Operating Procedures (SOPs) for every process and step involved which are being closely monitored to ensure that all concerned personnel are complying with these procedures.

Diagrammatic representation of present Q.C. activities:

Raw materials analysis:

The following parameters are tested for raw materials:

  1. Name of the Raw material, e.g. paracetamol B.P
  2. Appearance
  3. Melting point
  4. Infrared spectroscopy
  5. Thin layer chromatography
  6. Sulphated ash
  7. Heavy metal
  8. Assay

Bulk and Finished product analysis:

For the bulk and finished products the following features are tested:

  1. Appearance
  2. Identification
  3. Assay
  4. Average weight
  5. Weight uniformity
  6. Hardness
  7. Thickness
  8. Friability
  9. Disintegration
  10. Dissolution
  11. Related substances

Packaging materials Test parameters:

The following parameters are considered for packaging materials:

  1. Length
  2. Width
  3. Height
  4. Thickness
  5. GSM (gm/m2)
  6. Adhesion of ink
  7. Thickness of polyethylene/ thin film lacquer and aluminum layer
  8. Identification test of foil
  9. core (internal) and total diameters
  10. Appearance
  11. Text
  12. Design
  13. Identification test of PVC and PVDC
  14. Density of PVC and PVDC
  15. Mouth diameters (Both internal and external)
  16. Barcode
  17. Spike (Pierce) length
  18. Piercibility test etc.

Sampling of Raw materials:

First of all, there is a SOP for sampling raw materials. Also during sampling the environment is strictly controlled. The complete process of sampling is done under laminar air flow and HEPA filter and the class maintained is B. The temperature is always maintained below 25 OC while the humidity is never kept above 60%RH.

The following sampling plan is seen to be followed:

Type of RM Physical


Instrument No. of containers Points of sample withdraw from a container
API Solid Sampling Thief All Top, Middle and Bottom
Liquid Pipette
Excipients Solid Spoon +1
Liquid Pipette

Sampling Procedure:

Sampling is done according to SOP. The main steps are as follows:

Material receive

Checking of physical condition of the container

Collection of sample as per sampling plan

Use some for test and some as retention sample

1. Instrument lab:

Instrument lab consists of the following machine: —

?. FTIR (Fourier Transform Infrared Spectroscopy):

This machine is used to identification and quantification. Here KBr disk method is used for sampling. This machine is controlled by computer with software; name ‘Prestige-21’ which is developed by SHIMADZU, Japan.

??. GC (Gas Chromatogra