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Program in Pharma Good Manufacturing Practices

Course Overview

Good Manufacturing Practice regulations (GMPs) are used by pharmaceutical, medical device and food manufacturers as they produce and test products that people use. This course explores the regulations through which the Federal government controls the drug, cosmetics and diagnostic industries. Major emphasis is placed on understanding the need for and the intent of regulations and developing mechanisms for implementation and compliance. This course is intended to give participants an introduction to GMPs regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in assuring their validity. Those attending will also get an understanding of the needs for thorough and comprehensive training and documentation.
This course introduces students to the principles of GLP/GMP in the pharmaceutical and associated industries with the emphasis on the necessary procedures and documentation required to achieve full compliance.

Course Objectives

Upon completion of this course, students will have an understanding of the various aspects of GMP regulations including:

  • Attributes of materials, including formulation components, container and closure systems, labels and     labeling, materials in process, and finished pharmaceuticals.

  • Methodology, including documentation, manufacturing validation, quality assurance, quality control, and     supportive manufacturing operations.

  • Personnel and facilities, including building, equipment, instruments and infrastructure.
  • Analytical and laboratory validation and compliance programs.

Course Modules

  • Module I - Good Manufacturing Practices, Quality Assurance And Regulation

  • Module II - Quality Assurance And Control

  • Module III - Quality Assurance of Pharmaceuticals (Vol II)

  • Module IV -SCHEDULE -M

Eligibility: Any Science Graduate

Program Duration: The program duration is 6 months.

Program Fee

BII Program Participation Fee for this program is Rs. 8,000 for participants based in India / USD 600 for Overseas participants.

Download the Application Form
Admission Procedure
  • Submission of Application.

  • Enclosures.

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

Re-registration: Only once the candidate will be allowed to re-register himself for the course by paying the 50% of the course fee.

Download the Re-registration Form

Mode of Payment
Payment can be made through:
Demand Draft/Cheque in favor of Bioinformatics Institute of India at Delhi/Noida or NEFT.
NEFT (HDFC bank account details)
Account Name: Bioinformatics Institute of India
Bank Address: Sector 63 Gautam Budh Nagar Noida (U.P)
Current Account Number: 5020 0003 7096 35
IFSC Code: Hdfc0000975
MICR Code: 110240129
Branch Code: 000975

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