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Competent Person

Competent person is most commonly used word while applying for any type of license and registration in pharmaceutical industry. Most of new comers and sometimes even experienced persons could not be able to describe competent person in pharmaceutical sector.

Definition of Competent Person:

A competent person is a person who is eligible and authorized to conduct a specific pharmaceutical business means manufacturing procedure under pharmaceutical manufacturing, dispensing and compounding under pharmaceutical retail, sale and distribution under pharmaceutical wholesale business etc. Every business types require different qualification and requirements to become competent person.

Qualification and requirements for becoming competent person in different types of pharma businesses is as follow:

Pharmaceutical Manufacturing Company:

Number of Competent person required: 2 no.
  • Manufacturing Chemist
  • Analytical Chemist

Manufacturing Chemist:

Manufacturing chemist is a person who is authorised and responsible for all manufacturing activity conducted in a pharmaceutical manufacturing unit.

Qualifications and requirements:
  • A graduate in Pharmacy or Pharmaceutical Chemistry with eighteen month experience in pharmaceutical manufacturing, or
  • A graduate in Science (Chemistry) with three years experience in pharmaceutical manufacturing, or
  • A graduate in Chemical Engineering or Chemical Technology or Medicine) with three years experience in pharmaceutical manufacturing, or
  • Holding any foreign qualification and experience equivalent as discussed above


Analytical Chemist:

An analytical chemist is a person who is authorized and responsible for quality and testing of drugs manufactured under pharmaceutical manufacturing unit.

Qualification and requirements:
  • A degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry

Check out: How to start Pharmaceutical manufacturing company?


Pharmaceutical Marketing Company:

Number of competent persons: 1 No.

Qualification and Requirements:
  • Registered Pharmacist, or
  • Holds a degree of a recognised University with one year‘s experience in dealing with drugs
Check out: How to start pharmaceutical marketing company?

Pharmaceutical Distribution Business:

Number of competent persons: 1 no.

Qualification and Requirements:
  • Registered Pharmacist, or
  • Holds a degree of a recognised University with one year‘s experience in dealing with drugs
Check out: How to start pharmaceutical distribution business?

Pharmaceutical Retail Business:

Number of technical persons: 1 No.

Qualification and Requirements:

  • Registered Pharmacist
Check out: How to start pharmaceutical retail business?

Hope above information is helpful to you...
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