An educational report on industrial visit.

1. a report on industrial visit at pacific
pharmaceuticals
PRESENTED BY: FARYAL SARWAR (D18E07)
HAFSAH AZAM (D18E32)
PREPARED BY: HAFSAH AZAM (D18E32)

2. TABLE OF CONTENTS
 Introduction
 Brands by industry
 Sections in industry
Warehouse
QC Area
Production Area
Stability Room
Packaging Area

3. INTRODUCTION:
PACIFIC PHARMACEUTICALS is the only
pharmaceutical company of Pakistan that has been
certified by MHRA , a European Drug licensing authority
, giving it license to market its registered products in UK
and European region.
Over 180 registered products are being manufactured
by this industry.

5. BRANDS BY THE INDUSTRY:
Some products being manufactured by pacific
pharmaceuticals include:
Pacific’s DM-Decongestant (120ml)
Pacific’s DM(120ml)
Pacific’s Jack and Jill (120ml)

6. WAREHOUSE AREA:
These are the
departments in pharmaceuticals where raw
materials (Active and excipients) and packing
materials which are used in manufacturing
batches shall be received and stored at required
storage conditions.

8. RESPONSIBILITIES OF PERSONNEL:
Maintain the are clean and presentable
for audit
Follow good documentation practice
and safety instructions
Receiving raw materials and prepare
goods receipt note (GRN)
Recording of temperature , relative
humidity and differential pressure

9. Arrangement of raw materials and packaging
materials according to status i.e;
Under test approved
Rejected
Quarantine
Dispensing and issue of raw material and packaging
materials to production and packaging department

10. In warehouse there are DEEP FREEZERS (2-8
degree Celsius)
Cool temperature room (8-15 degree
Narcotics area ( this area is locked and is
opened by the incharge in presence of
pharmacist)

11. A Quarantine tag
Tells us about the status of raw material

12. AIR LOCKS:
Air locks help to protect the
classified area from contamination that may
occur during the entry and exit of personnel and
material.
PAL (Personnel Air Lock)- used for personnel
entry.
MAL (Material air Lock)- used for transferring
materials.
Pharmacist wears protective gear , goes from
PAL to MAL and then receive goods.

13. TYPES OF AIRLOCKS:
There are three types of airlocks:
Cascade airlock (have high pressure on one side
and lower pressure on other)
Bubble airlock (have high pressure inside the airlock
and lower pressure on both sides)
Sink airlock (have low pressure on inside the airlock
and higher pressure on both sides of airlock)

15. POSITIVE AND NEGATIVE PRESSURE:
Keep negative pressure inside the
controlled area (process area) as compared to
corridor area (positive pressure) to prevent
contamination.
BUFFER ZONE:
Generally , compounding area in
sterile pharmaceutical preparation facility is known
as buffer zone.
It is always ISO 7 area (class 10,000)
Differential pressure is between 10-20 Pascal.

16. QUALITY MANAGEMENT:
Traditionally, in pharmaceutical industry
the quality function is divided into two parts :
Quality control
Quality assurance
QUALITY CONTROL:
Involves operational techniques
Activities that are used to assume product
compliance to the specification.

17. QUALITY ASSURANCE:
Concerned with the events in the present
Focused on building quality into a product
through planned and systemic activities e.g
Validation process
Environmental control
Documentation
There is also an eye and body shower in lab in case
any contact with dangerous chemical happens.

18. FUNCTIONS OF QUALITY CONTROL:
To prepare detailed and written instructions to
carry out inspections , tests and analysis.
To establish written sampling plan and
sampling procedures.
To validate the method of analysis.
To maintain analytical record of tests of all
samples.
To participate in self inspection programme.

20. APPARATUS IN QUALITY CONTROL
LAB:
Dissolution test
apparatus
Hardness test
apparatus
Friability test apparatus
pH meter
Refractometer
UV Spectrometer
HPLC
Disintegration
apparatus
Viscometer
Sieve analyzer
Karl Fischer titrator
Potentiometric titration
apparatus

22. PRODUCTION AREA:
The production area has following characteristics:
Different category products should be
manufactured in different areas.
Flow of materials must be justified.
Area for production should be hard , smooth ,
impervious.
Adequate light fittings, ventilation, pipe work
Ventilation of rooms should be proper by
using HVAC system
Primary packaging should be done differently
than secondary packaging .

23. SUB-AREAS OF PRODUCTION AREA:
This area has following subareas:
Dispensing room
Granulation room
Compression room
Capsule section
Drying room
Coating room
IPQC area
Liquid manufacturing and filling area

24. DISPENSING ROOM:
The code that identifies the sub-inventory
where the batch consumes the dispensed
material is known as dispensing room.
OBJECTIVE:
To lay-down procedure for
dispensing of approved raw materials for
production.
SCOPE:
This applies to warehouse department
formulations.

25. A PHARMACEUTICAL DISPENSING BOOTH

26. GRANULATION ROOM:
In granulation room,
granulation is done with the help of different
types of granulators.
DIOSNA
GRANULATOR:

27. COMPRESSION ROOM:
In this room, granules are compressed
to form tablets.
Temperature(25 ±5ºC)
Humidity(50±5)

28. DRYING ROOM:
This room has different kinds of
dryers depending upon our product’s
requirement.
Most commonly used is TRUCK dryer.

29. IPQC AREA:
IPQC stands for ‘In process Quality Control’
area.
In this area, routine quality control tests are
performed during production.
They maybe performed at regular intervals
during a processing step or at end of process
step.

30. STABILITY ROOM:
It has stability chamber also known as climatic
chamber.
Product is stored at different temperatures
and humidity to check at which temperature
and humidity product stays stable.
Distilled water is kept at top of chambers to
create humidity.

32. PACKAGING AREA:
There are three types of pharmaceutical
packaging:
Primary packaging
Secondary packaging
Tertiary packaging
1-PRIMARY PACKAGING:
Materials used must be neutral
Blister strips and bottles are mostly used in
primary packaging
Materials used include
PE , PVC , Nylon etc

33. SECONDARY PACKAGING:
Layer of printed material like boxes and
cartons
On this printed paper , informative things like
drug’s active and inactive ingredients,
manufacturer’s address and name , side effects
and contraindications related to drug are
printed.

34. TERTIARY PACKAGING:
Important for shipping and transporting purposes.
Not seen by consumers
Materials used include :
Cardboards , plane boxes
There is also a serialization machine in packaging area.

35. PACKAGING MATERIALS:
The types of pharmaceutical packaging
materials include:
Glass
Plastic
Papers/Cardboards
Metals
Rubber

36. GLASS:
Most commonly and widely used as drug
packaging material.
 ADVANTAGES:
Transparent, good protection power, easily
labelled, economical.
DISADVANTAGES:
Easily broken, can release alkali to liquid
preparations.

37. PLASTICS:
Polymers of high molecular weight that
can be moulded into desired shapes.
ADVANTAGES:
Less weight than glass, flexible, essentially
chemically inert, safe, rigid.
DISADVANTAGES:
Poor printing, absorption permeable to
moisture.

38. METALS:
They are used for construction purposes.
Commonly used materials for this purpose are
tin, aluminium , steel, stain-less steel etc
ADVANTAGES:
Impermeable to light, moisture, gases.
Easy label printing
DISADVANTAGES:
Expensive, react with certain formulations.

39. RUBBER:
It is mainly used for closure of containers of
vials, transfusion fluid bottles.
ADVANTAGES:
Water absorption is very low
DISADVANTAGES:
Oil and solvent resistance is not good.
MATERIALS:
Nitrate, chloroprene, silicon etc.

40. PACKAGING FORMS:
Blister packs
pre-formed plastic/paper/foil packaging
used for formed solid drugs.
This usually has a backing of paperboard or a
lidding seal of aluminum foil or plastic film.
Blister packs are useful for protecting drugs
against external factors, such as humidity and
contamination for extended periods of time.

41. BOTTLES:
Bottles are commonly used for liquid
pharmaceuticals as well as formed tablets and
capsules.
Prescription bottles come in several different
colors, the most common of which being
orange or light brown.
Other common colors include: Clear , blue,
dark brown, green, and various opaque hues.

43. CONCLUSION:
We conclude that PACIFIC
PHARMACEUTICALS is GMP certified industry. It
is producing good quality product. The workers
and all the staff is high experienced and well
trained. This industry is good with proper
management system and developed laboratory.