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51 - LONG - Long-Term Programs
LONG 517 - Good Manufacturing Practice (GMP) (4 Weeks)
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Course Description
Good Manufacturing Practices (GMP) are a set of measures that aim to provide guidance for manufacturing, testing, and quality assurance in order to ensure that the products are safe for human consumption.
Course Objectives
- Know about GMP regulations and their application to laboratory activities, manufacturing processes and support functions,
- Gain a fundamental knowledge of the basis of GMP regulations,
- Demonstrate the need for thorough and comprehensive GMP training and documentation.
- Understand the common terminology and the role GMPs play in their day-to-day responsibilities.
- Managing the implementation of GMP efforts and proactively sustaining a culture of compliance in all scientific and manufacturing efforts.
Who Should Attend?
- Managers
-
Professionals
- Purchasers
- Anyone who is involved in Good Manufacturing Practice
Course Details/Schedule
Week 1
Introduction
- What is Good Manufacturing Practice?
- Why is GMP important?
- Official GMP Directives.
- The basic requirements of Good Manufacturing Practice.
Pharmaceutical Quality System (PQS)
- Principle and overview of the Pharmaceutical Quality System.
- Major updates.
- Development, contents and implementation of PQS
Week 2
Personnel
- Key personnel.
- Background and duties of the Qualified person.
- Duties of the Head of production department.
- Duties of the Head of quality control.
- Person releasing the batch and consultants.
- Personnel training and hygiene.
Premises & Equipment
- Premises.
- Production area.
- Storage area.
- Quality control areas.
- Ancillary areas.
- Equipment.
Week 3
Documentation
- Premises.
- Generation & control of documentation.
- Types of documents & specifications.
- Manufacturing formula & processing instructions.
- Packaging instructions.
- Procedures & records.
Production
- General principles.
- Prevention of cross-contamination in production.
- Guidelines for starting materials.
- Processing operations.
- Packaging materials and operations.
- Guidelines for finished products.
Week 4
Quality Control
- General principles.
- Main tasks of the Quality control department.
- Technical transfer of testing methods.
- Transfer protocol.
Complaints & Recalls
- GMP Guidelines related to complaints.
- Classification of defects.
- Product Recalls.
