GMP TRAINING for API (Bulk Drugs) pharmaceutical industry India

GMP Training for API (Bulk Drugs)

For officers in various sections of the firm.

Rationale behind GMP for bulk drugs
Differences in bulk drugs and formulations
Requirements of : Personnel, Premises, Equipment, Sanitation Cleaning, Hygiene, Documentation, Production and Distribution, Quality Control
Improvement and progress in GMP
Contribution of bulk drug in the quality of formulation
A effective vendor - buyer relationship
GMP a continuous ongoing effort

Coverage : New Schedule M Compliance

Coverage : ICH Q7A Compliance

Concepts and evolution of quality; My role and goal in quality
Who is my customer and what are his requirements and expectations
What is G M P and its relation with quality
Benefits for self and the organization on implementation of G M P
Information on requirements of Buildings, Facilities, F D A and its role in health care; Hygiene in work area, for machine and equipment, change-overs, containers and closures, status labels and product labels with relevant documentation
Avoiding Contamination, Cross- contamination, mix-ups and errors
Our role at the time of preparation and during F D A inspection
Attitude and G M P ; Action plan and Follow-up

Coverage : Skill Competency Awareness