FORMULATION DEVELOPMENT

1. Specifications
Critical Process Parameters (CPP)
In process controls (IPC)
Finish Product controls
for Injectable
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2. Sr.
No.
Manufacturing
Process details/Unit
Operation
Critical Process Parameters
(CPP)for Injectable Products
Controls of Intermediate
Products and Finished
Products/Quality Attributes
1.
Materials / Equipment
preparation
 Temperature / time of material
sterilization
 Define Sterilization loads
 Clean and dirty hold time
 Equipment drying time
 Cleaning processes
 Weighing of Raw-materials
 Materials compatibility
• Bio burden
• Endotoxins
• Cross-contamination
2.
Compounding
• Stainless steel tank
• Mixing speed / time
• Flow of Nitrogen
• Total holding time
• Light sensitivity
• Heat / cold sensitivities
• Samples storage conditions
• Temperature
• Dissolved Oxygen
• Assay
• Density
• pH
• Assay
• Related substances

3. Sr.
No.
Manufacturing
Process details/Unit
Operation
Critical Process Parameters
(CPP)for Injectable Products
Controls of Intermediate
Products and Finished
Products/Quality Attributes
3.
Filtration
• Filtered compressed Air /
Nitrogen Filters (autoclaved)
drying time Filters contact time
• Filter Compatibility with product
Filtration pressure
• Filtration flow-rate
• Filtration temperature
(according to validation)
• Type of sterilizer filter
• Integrity test to the filter
• Aseptic technique
• Assay
• Density
• pH
• Bio burden
• Filter validation studies
4.
Filling
• Temperature
• Fill volume
• Speed of filling
• Nitrogen overlaying
• Aseptic technique
• Volume / Weight variation
• Color/ clarity (if applicable)
• Assay
• Related substances / Purity
• pH
• Oxygen headspace
• Endotoxins
• Sterility

4. Sr. No.
Manufacturing Process
details/Unit Operation
Critical Process Parameters
(CPP)for Injectable Products
Controls of Intermediate
Products and Finished
Products/Quality Attributes
5.
Lyophilisation (if
applicable)
• Product temperature
• Freeze dryer shelves
temperature
• Chamber pressure
• Appearance
• Reconstitution time
• Leak test
• Uniformity of content
• Uniformity of mass
• Assay
• Water content
• pH
• Related substances
• Particles after reconstitution
• Endotoxins
• Sterility
6.
Final sterilization
(if required)
• Temperature / time of
product sterilization
• Sterility
• Assay
• Related substances
7. Inspection
• Finish Product quality
attributes – optical
inspection machine / visual
inspections
• Particles
• Defects