Pharmaceutical Industry OVERview

A pharmaceutical company is a commercial business licensed to research, develop, market and distribute drugs, most commonly in the context of healthcare.

The major areas pharmaceutical company got inside are  given below:

• Safety protocol section
• Warehouse facilities for RM (Raw Materials)
• Liquid preparation section & packaging
• Solid preparation section & packaging
• Semisolid preparation section & packaging 
• Parenteral preparation section & packaging
• Warehouse facilities for FG ( Finished Goods)
• QC (quality control) & QA (quality assurance) section 

Safety Protocol Section

Square Pharmaceuticals LTD. does not compromise about the safety of their products. So their safety protocols are very tight. The safety protocols are maintained very strictly. The rooms are air locked. When entering each section, apron, masks, shoes cover must be put on to inhibit contamination.

According to their form of preparation and concern of contamination the safety protocol is divided into 4 categories. They are level A, level B, level C & level D.

Level A is for highly sensitive drugs like parenteral preparations, and Level D is for solid dosage form which is less prone to contamination.

Every section is separated from the outside world and from section to section according their safety level by ILR (Inter lock room). The employees have to wear various layers of safety dresses according to the safety level so that the contamination does not reach the section.

The preparation chamber is room with high pressure in comparison to the corridor so that the microbes or contaminations don’t enter the chamber. The whole factory’s pressure & temperature is maintained by advanced EVAC system.

Warehouse Facilities for RM

RM means Raw Materials. When a drug needs to be prepared, the API (active pharmaceutical ingredients) & the excipients are ordered 3 months earlier. Here the raw materials are stored. The environment is controlled in accordance to the nature of the raw materials. After passing the QC and QA, they are stored here. The failed materials are discarded. They are kept in the RM warehouse for staging and testing. If they pass the tests then they are released for production.

Liquid Preparation Section & Packaging 
There are several rooms for several works in preparation of liquid dosage form. They are shown below:

• Sugar liquefying chamber
• RM (raw Material) staging chamber
• API & excipients mixing chamber 
• Contamination determination chamber
• In process check-IPC
• Filling section 
• Utensil washroom 
• Primary packaging 
• Secondary  Packaging

FIG: Liquid preparation mixing machine

Solid Preparation section and packaging 
It is prepared in the D section. Solid dosage form are prepared by a compressing machine. There are three methods of which a tablet can be prepared-

a)     Dry granulation

b)    Wet granulation &

c)     Direct granulation.

Mainly the wet granulation method is used because it is more sufficient and produces quality preparation. The methods of wet granulation are given here under-

• Sieving
• Dry mixing.
• Adding solvent for wetting the API.
• Again dry the mold.
• Milling the preparation.
• Lubricating to get good product.
•  Compression.

FIG: VB blending machine & Compressing Machine

Semisolid preparation 
Semisolid preparation includes cream, ointment, gel etc. The preparation of semisolid dosage form includes the following steps-

• Compounding line.
• Separate Containers for water and oil phase.
• CIP Skid room  
• Dispensing of Preparation
• Primary packaging (Tube filling with AXO 2400)
• Secondary packaging.

FIG: Axo 2400 

Parenteral Preparation & Packaging
In this section two types of products are prepared,

1.     Ampules- for single dosage only

2.     Vials- for multiple dosage

These preparations are very sensitive, so A level safety measures are followed. After preparation they are rapidly packaged (primary) to avoid any types of contamination. After primary packaging, secondary packaging is introduced.

FIG: Ampule Packaging Machine

Quality Control (QC)
This section deals with the checking of the Raw materials & Finished Goods. All Parameters are checked to ensure the best quality of the products. All the analytical tests are done here. They check if the product is following USP/BP methods and parameters properly. There are two types of tests,

1.     Visual/Physical test

2.     Chemical/Identification test.

 The machines & reagents used are showed below,

• Karl Fisher Reagent
• P^H meter- to determine p^H of the preparation

FIG: PH meter

• Disintegration tester-used to measure the disintegration level.

FIG:  Disintegration Test

• Polari meter (AutoPol)- to determine the polarity

FIG: Polarimeter

• Injector
• Graphite Tube Atomizer (GTA-120)

FIG: GTA-120 (atomizer

• UHPLC- Ultra High Performance Liquid Chromatograph

•  Hardness Tester

•  Friability Tester

•  IR Analyzer

• Emergency Eye Washer

•  Particles Size Analyzer (Malvern)

•  Sonicator

•  HAPA printing Machine

•  Blender

Finished Goods Ware House (FGWH)
In this facility finished products are kept. Before coming here they go through QC. Mostly they are ready for marketing. Mainly 5 types of temperature are maintained according to the product physiology, they are,

·        Freezing temperature:

-20 to -10 degree Celsius

·        Cold temperature:

-10 to -2 degree Celsius

·        Cool temperature:

8 to 15 degree Celsius

·        Room temperature:

 15 to 25 degree Celsius

Even the pressure and humidity of the storage facility is also maintained. The light sensitive products are kept in light resistant vessels. From here the products are released for marketing.