Scribd Logo
Upload

Welcome to Scribd!

  • CPP and CQA of Different Stages of Solid Oral Dosage Forms: Sr. No Unit Operation Process Parameter Quality Attributes

    Uploaded by

    Anil Anee
    459 views2 pages
    The document discusses the critical process parameters (CPP) and critical quality attributes (CQA) of different unit operations in solid oral dosage form manufacturing. It lists 10 unit operations - mixing, milling, wet granulation, spray granulation, drying, roller compaction, blending, compression, drying, and coating. For each unit operation, it identifies the key process parameters that need to be controlled to influence the critical quality attributes of the final product. Maintaining tight control of CPPs during manufacturing is important for ensuring consistent CYAs.

    Original Description:

    Original Title

    CQA & CPP

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    The document discusses the critical process parameters (CPP) and critical quality attributes (CQA) of different unit operations in solid oral dosage form manufacturing. It lists 10 unit operations - mixing, milling, wet granulation, spray granulation, drying, roller compaction, blending, compression, drying, and coating. For each unit operation, it identifies the key process parameters that need to be controlled to influence the critical quality attributes of the final product. Maintaining tight control of CPPs during manufacturing is important for ensuring consistent CYAs.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    459 views2 pages

    CPP and CQA of Different Stages of Solid Oral Dosage Forms: Sr. No Unit Operation Process Parameter Quality Attributes

    Uploaded by

    Anil Anee
    The document discusses the critical process parameters (CPP) and critical quality attributes (CQA) of different unit operations in solid oral dosage form manufacturing. It lists 10 unit operations - mixing, milling, wet granulation, spray granulation, drying, roller compaction, blending, compression, drying, and coating. For each unit operation, it identifies the key process parameters that need to be controlled to influence the critical quality attributes of the final product. Maintaining tight control of CPPs during manufacturing is important for ensuring consistent CYAs.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    CPP and CQA of different stages of Solid oral dosage forms

    Sr.
    no Unit operation Process parameter Quality attributes
    1. Order of addition Particle size distribution
    2. Mixer load level Bulk/tapped density
    3. Impeller speed and time Moisture content
    1. Mixing
    4. Chopper speed and time Flow properties
    5. Chopper ON/OFF Pattern
    6. Mixing time
    1. Impact/cutting/screening mills
    Particle size
    direction.
    2. Milling 2. Speed of mill Particle shape
    3. Screen size Flow properties
    4. Feeding rate Polymorphic form

    1. Pre-binder addition mix time


    Blend uniformity Flow, Moisture
    2. Impeller speed and ON time content Particle size and distribution
    Wet Granulation
    3. addition Granule size and
    (RMG) 3. Chopper speed and ON time
    distribution Granule strength and
    4. Binder fluid temperature uniformity Solid form
    5. Binder addition rate and time
    6. Post-granulation mix time
    1. Spray nozzle type and location
    2. Binder addition rate and time
    3. Bowel temperature

    4. Fluid bed granulations Mixing time Blend uniformity Flow Moisture


    Spray nozzle (type/quantity/ content Particle size and distribution
    Spray Granulation pattern/configuration) addition Granule size and
    4.
    (FBE) distribution Granule strength and
    5. Binder fluid temperature uniformity Solid form, Moisture
    6. Inlet air flow rate, volume, content, Residual solvents
    temperature, and dew point
    7. Exhaust air temperature,
    8. Shaking intervals
    9. Product temperature
    1. Inlet air flow rate, volume,
    temperature, and dew point Granule size and distribution
    2. Bowel temperature Granule strength, and uniformity
    5. Drying (FBD) Particle size Flow Bulk/tapped
    3. Exhaust air temperature, density, Moisture content Residual
    4. Shaking intervals solvents
    5. Product temperature
    CPP and CQA of different stages of Solid oral dosage forms
    Sr.
    no Unit operation Process parameter Quality attributes
    1. Tray Quantity carts and trays per
    chamber
    2. Quantity of product per tray
    Granule size and distribution
    3. Drying time and temperature Granule strength, and uniformity
    6. Drying(Tray dryer) 4. Air flow Particle size Flow Bulk/tapped
    5. Inlet air temperature and dew point density, Moisture content Residual
    6. Jacket temperature solvents.
    7. Condenser temperature
    8. Vacuum strength
    1. Roll speed
    2. Gap setting Appearance Ribbon/particle size and
    7. Roller compaction 3. Roll pressure shape Ribbon density, strength, and
    4. Auger screw rate thickness Solid form
    5. Roller type
    1. Blender type Blend uniformity
    8. Blending 2. Blender RPM Flow properties
    3. Blending time
    1. Compression speed
    2. Force Pre-compression
    3. Force main compression Target weight, Weight uniformity
    9. Compression 4. Force Feed frame type and speed Content uniformity, Hardness
    5. Hopper design, height, Thickness, Tablet porosity Friability
    6. Depth of fill
    7. Punch penetration depth
    1. Product temperature
    2. Total pre-heating time
    3. Spray nozzle (type/quantity/
    pattern/configuration)
    4. Individual gun spray rate
    5. Total spray rate Visual attributes, Moisture content,
    Weight of core tablets
    6. Pan rotation speed
    10. Coating Appearance, Visual attributes , %
    7. Atomization air pressure Pattern Weight gain, Film thickness, Color
    8. Air pressure uniformity , Hardness Thickness
    9. Inlet air flow, temperature, dew point
    10. Exhaust air temperature, air flow
    11. Product temperature
    12. Total coating time

    You might also like