Part of process validation in which process flow is explained for sterile process and a non sterile process

1. Process flow for Non-Sterile Process
Stage 1
Process
design
HC guidelines
Master Process validation plan
SOP
Process validation Protocol
{Manufacturing conditions, Operating parameters,
Process limits, Batch size, RM inputs, Equipments,
Sampling (sampling points, no. of samples,
frequency)}
Protocol approval
Training of the personnel
Execution of Protocol
3 consecutive batches
Process validation Report and documentation
Change control and deviation
CAPA
Revalidation (if required)
Commercial production
Distribution of product
Strategies for
process control
Building and
capturing
process
knowledge and
understanding
Stage 3-
Continued
Process
Verification
Validation of Design of the facility
Installation qualification
Calibration and qualification of Equipment
Operational qualification
Stage 2
Process
Qualification
Product concept
Process development
Design of experiments (DOE)
Lab scale and pilot scale (scale up) studies
Raw material, equipment
Process parameters and flow
In process controls and unit operations
Product specifications
Design of
facilities and
Qualification
of equipment
and utilities
Process
Performance
qualification
(PPQ)
Data collection
and analysis of
product and
process
Process
variability
studies
Monitoring
Operational limits
In process monitoring

2. Process flow for Sterile Process
Stage 1
Sterile
Process
design
HC guidelines
Master sterile Process validation plan
SOP
Process validation Protocol
{Manufacturing conditions, Operating parameters,
Process limits, Batch size, RM inputs Equipments,
Sampling (sampling points, no. of samples, frequency)}
Protocol approval
Training of the personnel
Execution of Protocol
Process Simulation
(start up, processing operations, aseptic connections,
filling, closing)
Microbiological media
Worst 3 batches
(Incubation Time – 14 to 21 days., Fill Volume, Analytical
tests and evaluation for microbial growth, No. of units
manufactured, Personnel Frequency of testing, Raw
material quality, Packaging material testing
requirements.)
Process validation Report and documentation
Change control and deviation
CAPA
Revalidation (if required)
Commercial production
Distribution of product
Strategies for
process control
Building and
capturing
process
knowledge and
understanding
Stage 3-
Continued
Process
Verification
Validation of Design of the facility
Installation qualification
Calibration and qualification of Equipment
Operational qualification
Clean room setup, qualified and controls in place
EM and analytical method validated
Stage 2
Process
Qualification
Sterile Product concept
Sterile Process development
Design of experiments (DOE)
Lab scale and pilot scale (scale up) studies
Raw material, equipment
Process parameters and flow
Sterile In-process controls and unit operations
Product specifications
Design of
facilities and
Qualification
of equipment
and utilities
Process
Performance
qualification
(PPQ)
Data collection
and analysis of
product and
process
Process
variability
studies
Monitoring
Operational limits
In process monitoring