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Pharma Quality Control and Quality Assurance (12 Months)


Essentially, quality control involves the examination of a product, service, or process Quality is always an imperative prerequisite when we consider any product. It becomes prime when it relates to life saving products like pharmaceuticals. Although it is mandatory from the government and regulatory bodies but it is also a fact that quality of a pharmaceutical product can not be adequately controlled solely by pharmacopoeia analysis of the final product. Today quality has to be built in to the product right from its inception and rigorous international environmental, safety and regulatory standards need to be followed. Validation had proven to be an important tool for quality management of pharmaceuticals. According to ISO 9000:2000.Quality control is a process employed to ensure a certain level of quality in a product or service. It may include whatever actions a business deems necessary to provide for the control and verification of certain characteristics of a product or service. T he basic goal of quality control is to ensure that the products, services, or processes provided meet specific requirements and are dependable, satisfactory, and fiscally sound.

Course Description:

Quality assurance is a part of the overall management of any project, while quality control is the technical activity and documentation to pursue quality objectives. Quality is an integral and vital component of any sampling and analysis effort. Both Quality Assurance (QA) and Quality Control (QC) are intended to ensure that the data collected are adequate to fulfill project objectives. These concepts are of vital importance in highly demanding and quality conscious industry like Pharmaceutical industry.

  • Pharma Quality Assurance and Control Course is easy to learn and comprehensive. It teaches not only the basic concept related to the subject, but also covers advanced topics as well.
  • This course will help participants to understand and implement quality assurance and quality control for the particular operation during drug development.
  • The course also covers useful concepts like Six Sigma and its application in the Pharma industry.
  • The course will help in better understanding of drug development process and its importance in the Pharma Industry.

Eligibility : Any Science Graduate

Program Fee

BII Program Participation Fee for this program is Rs 10,500 (for participants based in India / USD 750 ( for overseas participants ). Payment is to be made through Demand Draft / At Par Cheque in favor of Bioinformatics Institute of India.

Examination Fees

Every student has to pay Rs.500/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module

Download the Examination Form

Course Objectives:

This program will provide students with variety of topics related to the up-to-date regulations, analytical monographs, basic organic and analytical chemistry, working knowledge of analytical instrumental techniques (HPLC, UV-Vis, FT-IR, TLC, GC and dissolution), computerized integrators and troubleshooting techniques and microbiology knowledge in the pharmaceutical area. Students will perform complex chemical and physical analysis on a wide range of pharmaceutical products in accordance with established procedures and analytical monographs such as US pharmacopoeia and British Pharmacopoeia. Quality assurance program will bring to the students a wide range of knowledge of quality assurance guidance GMP, GLP and ICH in all areas that impact drug quality. Students will get knowledge about quality system and Good Documentation Practices (GDPs), SOPs and principles of product complaints, product recall, returned goods, change control and CAPA. They will learn how to manage validation protoco l, batch documents and investigation report and be familiar with facilities audit. At the end of the course students will manage GMP and quality related issues as well as various regulatory requirements. Course will introduce to the students essential knowledge of regulatory across a broad range of healthcare products including medical devices, pharmaceutical, biologics and combination products.

The Pharmaceutical Quality Assurance & Quality Control program combines theoretical knowledge with hands-on skills in all areas that impact drug quality. The program is innovative and unique in offering in-depth, hands-on learning provided by full-time research faculty with both academic and industry experience. The student will study in a GMP compliant facility with modern state-of-the art equipment where you will gain valuable experience in pharmaceutical analytical instrumentation, documentation, GMP compliance, auditing, technical writing and quality assurance processes and procedures.

Course Modules

  • Module I : Quality Assurance in Pharma Industry-I
  • Module II : Quality Assurance in Pharma Industry-II (WHO Perspective)
  • Module III : Good Manufacturing Practices, Quality Assurance and Regulation
  • Module IV : Quality Assurance and Control
  • Module V : Pharma Regulation Practices & Procedures
  • Module VI : Statistical Quality Control and Biostatistics
  • Research Study

Pharma Quality Assurance and Quality Control Industry

Pharma quality control remains extremely important and specialists in this field will continue to be needed, because of automation, more tasks that once fell to quality assurance engineers can be handled by production workers. There are probably more opportunities in other sectors of the economy, particularly in health care where quality assessment is a relatively new idea.

Career in Pharma Quality Assurance and Quality Control

  • Quality assurance technicians or analysts
  • Quality assurance or control managers
  • Quality Researcher
  • Quality Assurance Engineer
  • Quality Assistant

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