Engaged. Knowledge. Application
Subpart F - Production and Process Controls PACKAGE
This package includes:
- Reference Article
- PDF PowerPoint Presentation
- Trainer Instructional Notes
- Audit Checklist
➢ 211.100 Written procedures; deviations
Changes
Deviations-Example
➢ 211.101 Charge-in of components
Formulation
Control of components
Supervision
➢ 211.103 Calculation of Yield
Theoretical yield
Actual yield
Percentage of theoretical yield
Calculating yield
➢ 211.105 Equipment identification
Contents of manufacturing containers and major equipment
Examples of product contents
Identification of major equipment
➢ 211.110 Sampling and testing of in-process materials and drug products
Written procedures
In-process specifications
In-process testing
➢ 211.111 Time limitations on production
Time limits
➢ 211.113 Control of microbiological contamination
Non-sterile products
Sterile products
➢211.115 Reprocessing
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