Sunday, 9 July 2017

Different departments in a Pharmaceutical Company

"This Article would be helpful for freshers, starting there career in Pharmaceutical Industry and to understand what actually the Pharmaceutical Industry is! and how many possible departments are present in a Company"

Basically, Pharmaceutical Company pumps in too much of Infrastructure, Technology, Manpower, huge amount of material management from one's ware house to offshore customers.
And after all this risk pertaining situation, still their is BIGGEST Hurdle that one has to overcome, that is USFDA-Audit.

To, pass swiftly from all this above assessment, the smooth working and amalgamation of all the department is key to success.

Generally, we can divide Pharmaceutical organization in three parts:

A. Corporate Office 

B. Research & Development Facility

C. Production Units

All, Functional units or Departments in Pharmaceutical Company can roughly divide in above categories.
We, will discuss above category in brief and definitely have a clear idea regarding all departments.

A. Corporate Office:

Corporate office, is place from where all the actions are planned and monitored. we can say, Corporate office is a functional unit of whole organization. 
For the successful business, growth, profit, expansions the department is responsible is Corporate office. For fame of company they are responsible and also for blame they are only responsible.

Department which are active at Corporate are as follows:
  1. CEO Office: Chief Executive Officer, is the most important person and working force for all organization. He heads and act as a Head of all Departments at Corporate office. His decisions matters a lot, can took to the company name, growth, fame  to the height of sky and the same to the depth of bankruptcy.
  2. Business development: Business development is a department which earns the money for the company. They have to plan to reach the highest point in terms of sales of product as well as monitor the competitors action. Focus on either possible ways of extensive marketing policy and attracting customers and maintaining the healthy relationship in terms of business to keep to rising and growing.
     Qualification to Work in Business Development: MBA from Top Management School, Pharma MBA is also preferred, BBA (Bachelor of Business Administration)
  3. Marketing:  Marketing works for the sales, promotion of the products in the portfolio. Their work is target oriented within tight timelines.
    Qualification: MBA is preferred, Bachelor of Pharmacy, or Diploma in Pharmacy can work in this department.
  4. Accounts: Accounts department responsible for all the payment onshore as well as offshore. As Pharmaceutical market in located all over the globe, accounts deals with all the national as well as international transactions. They also tracks all the taxes, profit and loss for whole year. Qualification: Masters/Bachelor of Commerce, Chartered Accountants.
  5. Import and Export: Operates for smooth transportation of Products from place to place or country to country.
    Qualification: MBA, or Experience in a Field.
  6. Portfolio Management: This Department takes decision for Company Product Portfolio, means which product is to included or should be excluded from Portfolio. We can say they are product forecasting department for company.
    Qualification: M.Pharmacy, Business Analytics, One has to perform too much of different analysis.
  7. Licensing: This Department looks after the different Licenses mandatory for Pharma-company as per State and Central Government of India.
    Qualification: Any Degree holder with a experience in the field.

B. Research & Development:

Research & Development facility are of different type as per the requirement of company. One can consider the Research & Development facility as a generalized term for different R&D.
First, I will enlist some different type of R&D:
  • Formulation R&D: Research regarding different formulation is carried out here.Research limited to Formulation only.
  • Analytical R&D: Research is focus and confined to analysis of different samples or products. Analysis by using different analytical instrument like NMR, MASS, DSC, FTIR, HPLC, XRD and TG etc.
  • Synthetic R&D: Research is focused on synthetic reactions where, new synthetic routes or new compounds are synthesized.
  • Drug-Discovery R&D: From scratch the product development or discovery is started. Different techniques or process are incorporated for outcome of a complex new molecules.
  • Clinical R&D: Clinical research is carried on animals or on human subjects. Clinical trials are carried out in this R&D facility.
  • Bio analytical R&D: Research is focus on trials of drug on human subject, Evaluate the Molecules for Bio-availability or Bio-equivalence studies.

Different department collaboratively working in R&D:

  1. R&D department: This R&D may any of the one mentioned in above points.
    Qualification: PhD, M.Pharmacy, M. Science, B.Pharmacy, B.Science
  2. QA department: QA assures the quality work done. With the documentary proof for all the workdone. Its one of the major role is facing Audits as well as training for employee.
    Qualification: M.Pharmacy (Quality Assurance),
  3. Regulatory Affairs: Role of this department is to carry out different filing to USFDA, EMEA. As, per prescribed format and timelines. They, has to file the (Drug Master Dossier) DMF to USFDA  and (Certificate of Suitability) CEP to EMEA europe regarding their products.
    Qualification: PhD, M.Pharmacy (Regulatory Affairs) (Pharmaceutics)
  4. Project Management: Responsible for getting workdone by other department within specific mentioned timelines.
    Qualification: M.Pharmacy, MBA

  5. Intellectual Property Management: Responsible for patent filing for new inventions and internal R&D support.
    Qualification: PhD, M.Pharmacy (Pharmaceutics) (Pharmaceutical chemistry)
  6. Quality Control: They perform the quality check for all raw material as well as finished products.
    Qualification: PhD, M.Pharmacy, M.Science
  7. Supply Chain: Maintains and Procures the material as per requirement of R&D.
  8. Purchase: Responsible for Purchase of all materials at the site.

C. Manufacturing Units:

Manufacturing unit is a place where this valued product is manufactured at specific guidelines required by FDA.
Manufacturing facility may differ from formulation to formulation. Below are different formulation which required different setup for formulation.
  • Tablets- Oral solid dosage form
  • Capsules
  • Pareneterals
  • Suspensions, Emulsions
  • Metered dosage Forms
  • Nutraceuticals etc

Disclaimer: Author is not imitating any organizations or company, the total article is only for information for young professionals in Pharma field. 

Wednesday, 14 October 2015


Ultra-violet spectroscopy/Spectrometry

Ultraviolet/Visible absorption spectroscopy is a measurement of attenuated beam of light after passing through a sample or after reflecting from a sample surface. 

Basic Principle: Valence shell electronic transition

Application of UV-Spectroscopy:
  1. Detection of functional group.
  2. Detection of impurities.
  3. Qualitative analysis and Quantitative analysis.
  4. Single compound without chromophore.
  5. Identify drugs with chromophoric reagent.
  6. To identify the conjugated compounds.
Instrumentation of UV-Spectroscopy:

A wavelength selector that uses diffraction grating or prism and allows continuous variation of nominal wavelength.

A wavelength selector that uses either absorption and destructive interference to control range of selected wavelength.
Absorption filter: Narrow effective bandwidth 30 to 250 nm and maximum throughput 10%
Interference filter: Narrow effective bandwidth 10 to 20 nm and maximum throughput 40%  

Stray light:
Stray light is a light in a optical system, which not intended in the design of instrument/spectroscopy.
In short, it is a unwanted light present in the optical system.
This problem is overcome by using double monochromators in the instrumentation.

Chromophore is part of a molecule or a structure, which is responsible for colour of the molecule or compound. The colour is obtained by absorbing one of the visible wavelength and reflecting back the remaining ones.

An auxochrome is a functional group of atoms attached to the chromophore which modifies the ability of the chromophore to absorb light, altering the wavelength or intensity of the absorption.

List of detectors and principle: 
Pt strip in evacuated vessel
Resistance change
Thermocouple and Thermophile
Two dissimilar metals.
Ex: Bismuth and Antimony
Voltage or EMF change at junction
Goley Cell
Xenon gas
Membrane displacement or expansion of gas
Triglycerine sulphate used as a medium
Electric polarization producing current.
Oxide of Co, Mg, Ni
Resistance change

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Tuesday, 30 December 2014

Classification of Drugs acting on central and peripheral nervous system


Anti-psychotics are used in used different clinical diseases such as schizophrenia, schizoaffective disorder,bipolar disorder, psychotic disorder, insomnia, dementia.

  • Classification based on Generations (1st, 2nd)

  • Classification based on typical and atypical type of anti-psychotic:

Mechanism of anti-psychotic Drugs:

  • General mechanism:

  • Some important mechanism of anti-psychotic drugs :

    Monday, 1 December 2014


    Calcium oxalate crystals shape and examples of sources:

    Type of Calcium oxalate crystals
    Prism/Single crystals
    Quillaia bark, liquorice, quassia wood, hyocyamus, clove stalk, senna, cascara, rauwolfia, kurchi, coca
    Cluster Crystals
    Senna leaf, Stramonium leaf, rhubarb, clove, wild cherry bark
    Rosette crystals
    Rhubarb, umbelliferous fruits(coriander, fennel, anise, celery)
    Acicular Crystals/ Raphides
    Single Acicular – Gentian root, cinnamon bark, gentian
    Bundle of acicular – squill , ipecac root
    Micro Crystals/ Crystals sand/ Micro sphenoid
    Cinchona, belladonna leaf
    Digitalis and aloe

    Different shape of  calcium oxalate crystals
    Actual crystals under microscope

    Sunday, 30 November 2014



    Types of tablet:

    A. Immediate release tablets: The tablet is intended to release rapidly after administration, or the tablet is dissolved and administered as solution. 
    Most common types are:
    1. Disintegrating tablets 
    2. Chewable tablets
    3. Effervescent tablet
    4. Sublingual and buccal tablets 
    5. Lozenges
    B.Modified release tablets : They have release features based on, time, course or location and must be swallowed intact.

    Classification of lubricants:

    Insoluble Lubricants
    Stearate(magnesium S., Calcium S., Sodium s.)
    Reduce tablet strength, prolong disintegration, widely used.
    Insoluble but not hydrophobic
    Both lubricant and Binder
    Liquid paraffin
    Up to 5
    Dispersion problem, inferior to stearate.

     List of water soluble lubricants:

    Water soluble lubricants
    Concentration range (%w/w)
    Boric acid
    Sodium benzoate
    Sodium oleate
    Sodium acetate
    Sodium Lauryl sulphate(SLS)
    Magnesium lauryl sulphate (MLS)


    Binders or adhesives are the substances that promote cohesiveness. It is utilized for converting powder into granules through a process known as granulation.

    Classification of binders:

    Natural binders
    Synthetic/Semi-synthetic Polymer
    Methyl cellulose
    Liquid glucose
    Ethyl cellulose

    Hydroxy Propyl Methyl Cellulose(HPMC)

    Strach paste
    Hydroxy Propyl Cellulose(HPC)

    Pregelatinised starch
    Sodium Carboxy Methyl Cellulose

    Alginic Acid
    Polyvinyl Pyrrolidone

    Polyethylene glycol(PEG)
    Polyvinyl Alcohols, Poly methacrylates.