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cGMPs for Finished Pharmaceuticals

This course provides the understanding of cGMP’s that everyone supporting manufacturing needs. 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 the ‘why’ behind cGMP’s and how to apply its principles to specific situations.

Who Should Participate:	Managers, Scientists, and Engineers, Production & Laboratory Leaders
Class Length:	Normally six hours
Course Prerequisites:	None
Course Objectives:	At the conclusion of the class a participant will have an understanding of the following:

The Code of Federal Regulations, Pharmacopoeias, and Guidance Documents as source information
Who is the FDA and what power do they have?
How employees should act during an FDA inspection
How FDA communicates with the company: Form 482, Form 483, Establishment Inspection Report, Warning Letters, Consent Decrees
Why FDA considers all products not made by cGMP’s to be adulterated
Organization and Personnel

Roles and responsibilities of Manufacturing, Quality Assurance, Management and Employees
Personnel qualifications and training.

Buildings and facilities

Cleaning & maintenance
Specialized systems & clean rooms
Facility Records

Equipment

selection, design, size, and location
calibration & maintenance
automatic, mechanical, and electronic
filters
Preventive maintenance
Cleaning and use log

Control of Components, Containers, and Closures

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

Production and process control

SOP’s, deviations
Charging components
Yield calculation
Equipment identification
In-process sampling and testing
Time limitations
Control of microbiological contamination
Reprocessing

Packaging and Labeling Control

Materials usage criteria
Label issuance
Packaging and labeling operations
Inspection
Expiration dating

Holding and distribution

Warehousing and Distribution procedures
Recalls

Laboratory Controls

Testing and release
Stability
Special testing requirements
Reserve samples
Laboratory animals
Out-of-Specification results

Records and Reports
- Component, container, closure, and labeling
- Master production and control
- Batch production and control
- Production record review
- Laboratory
- Distribution
- Customer complaints
- Document management systems
Quality Systems

Change management
Corrective Action/Preventive Action
Deviation control
Management review

Returned and Salvaged Products