Introduction:
Adulterated Medicinal Products
Basic Requirements of Manufacturing of Sterile Medicinal Products
Pre-requisites for Sterile Manufacturing
Workshop (Environmental Factors Affecting Product Sterility)
Regulations and standards
European cGMP driving force
ISO 14644 for Clean Room
Scope of Environmental Monitoring Program
Scope and limitations of EM
European regulation for clean room
Clean Room Standards (US/EU)
Clean Room Specifications, Design and Validation
Clean room components
Clean room specifications
Clean Room Design & Policies
Validation Requirements
Establishment of a Routine EM Program
Is it EM program or EM SOP?
Monitoring of non-sterile manufacturing area
Validation, Implementation and Managing an EM Program
Developing Policies, Procedures and Protocols
Elements of Performance Qualification Protocol
Instruments and testing procedures used for EM Program
Personnel monitoring
Accuracy of EM data
Microbial identification in an effective EM Program
Establishing action and alert limits
Managing out-of-specification test results (OOS)
Environmental Data Summary and Trending
Investigation and Corrective Action Program
Key issues for compliance in EM
Attendants Evaluation
Clean Room validation (DQ, IQ, OQ, PQ)
Workshop (Developing SOP for Air sampling of sterile filling room)
18(hours)