Pharma Good Manufacturing Practices (6 Months)

Overview and Objectives

Good Manufacturing Practice regulations (cGMPs) 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 cGMP 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.

Benefits of Course

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

Program Areas

• Module I- Good Manufacturing Practices, Quality Assurance And Regulation
• Module II- Quality Assurance And Control
• Module III- Quality Assurance of Pharmaceuticals
• Module IV- SCHEDULE M

Program Fee

BII Program Participation Fee for this program is Rs 7,500 (for participants based in India / USD 600 (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.300/- per module as examination fees . Examination fee for overseas participants is USD 30 Per Module
Download the Examination Form

For further details and enquiries
Call:0120-4320801/02
Mob:09810535368, 9818473366
E-mail : info@bii.in

Global Students for any queries
E-mail : global@bii.in,
info@bii.in