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cGMPs for Pharmaceutical Operations Personnel

This course provides the understanding of cGMP’s that pharmaceutical operations need. It covers 21 CFR 210 & 211 in detail. By reinforcing the concept that quality is everyone’s responsibility it provides them with the tools to maintain compliance. The authors have included examples from over 60 total years of Quality and Production experience to illustrate how the regulations are applied. Participants will learn in plain english the importancy of following SOPs.

Who Should Participate:	Production Personnel. Anyone involved in warehousing, receiving, shipping, charging raw materials, operating equipment, taking samples, packaging, or labeling.
Class Length:	Normally four hours
Course Prerequisites:	None
Course Objectives:	At the conclusion of the class a participant will have an understanding of the following:

Who is the FDA and what power do they have?
How employees should act during an FDA inspection
Why FDA considers all products not made by cGMP’s to be adulterated
Roles and responsibilities of Manufacturing, Quality Assurance, Management and Employees
Personnel qualifications and training.
The importance of following SOPs.
Buildings and facilities

Equipment

calibration & maintenance
Preventive maintenance
Control of Components, Containers, and Closures

Receipt and Storage
Testing and approval/rejection
Use of approved components, containers, and enclosures
Rejected components, containers, and enclosures

Production and process control

SOP’s, deviations
Charging components
Yield calculation
In-process sampling and testing
Time limitations
Master production and control records
Batch production and control records
Control of microbiological contamination
Cleaning & maintenance

Cleaning and use log

Packaging and Labeling Control

Label issuance
Packaging and labeling operations
Inspection
Expiration dating

Holding and distribution

Warehousing and Distribution procedures
Testing and release
Records and Reports

Quality Systems

Change management
Corrective Action/Preventive Action
Deviation control