Overview of Manufacturing Process

Preparation for Formulation (ISO 7)

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Terms in this set (9)

Preparation for Formulation (ISO 7)

• Quality/release of APIs & excipients
• Cleaning/sanitization of production areas
• Pre-weigh raw materials

Drug Product Formulation (ISO 7)

• CIP/SIP of formulation tanks/reactors
• Addition of raw materials to tanks/reactors
• Continuous: start-up to reach steady state
• In-process sampling

Critical Process Parameters (Drug Product Formulation)

• Mixing time
• Temperature
• Mixing speed
• Tank holding time

In-Process Testing (Drug Product Formulation)

Chemistry:
• Assay
• pH
• Osmolarity
Microbiology:
• Particulate count - both viable/nonviable; presence of objectionable organisms
• Number of CFUs

Drug Product Filling (ISO 5)

• CIP/SIP of B/F/S, syringe/vial, or tablet filling equipment
• Filtration - membrane or terminal
• Ready-to-use containers or form, fill, and seal
• Integrity test of vial/syringe

Critical Process Parameters (Drug Product Filling)

• Empty vial weight check
• Filled vial weight check
• Filling time

Finished Product Testing (Drug Product Filling)

Chemistry:
• Color
• Rheology
• Particle size
• Assay
• pH
• Osmolarity
Microbiology:
• Particulate count - both viable/nonviable; presence of objectionable organisms
• Sterility/number of CFUs/endotoxins
• Container integrity

Secondary Packaging (Unclassified)

• Visual inspection
• Packaging into cartons
• Package inserts with product information
• Proper labeling for tracking
• Palletizing for shipping

Quarantine and Release (Unclassified)

• Quarantine of packaged product
• Release testing
• Quality assurance review and batch release