A GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.
Be able to understand the basics of Good Manufacturing Practice for medicinal products for human use and the current legal regulations and guidelines;
Have the confidence to outline the main GMP requirements related to premises, storage facilities, and personnel;
Get familiar with the principles of the GMP quality system and quality control and the important procedures when dealing with complaints and recalls;
Who Should Attend?
Supply Chain Managers
Day One: Introduction
What is Good Manufacturing Practice?
Why is GMP important?
Official GMP Directives.
The basic requirements of Good Manufacturing Practice.
Day Two: Pharmaceutical Quality System and personnel
Principle and overview of the Pharmaceutical Quality System.
Development, content and implementation of PQS.
Background and duties of the Qualified person.
Duties of the Head of the production department.
Duties of the Head of quality control.
Person releasing the batch.
Personnel training and hygiene.
Day Three: Premises and Equipment and Documentation
Quality control areas.
Generation and control of documentation.
Types of documents and specifications.
Manufacturing formula and processing instructions.
Procedures and records.
Day Four: Production
Prevention of cross-contamination in production.
Guidelines for starting materials.
Packaging materials and operations.
Guidelines for finished products.
Day Five: Quality Control, Complaints, and Recalls
Main tasks of the Quality control department.
Technical transfer of testing methods.
GMP Guidelines related to complaints.
Classification of defects.
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