 Validation
Master Plan
The
cornerstone of a validation program is a Validation Master Plan.
Biologics Consulting Group, Inc., has knowledgeable staff with experience
creating comprehensive Validation Master Plans tailored to serve
as a reliable foundation for any manufacturer's validation program.
Process
Validation
Biologics
Consulting Group, Inc. has formed an expert team to assist manufacturers
in addressing process validation compliance issues for new and previously
licensed biologic products. This team, composed of individuals with
product, manufacturing, statistical and compliance expertise will:
- Evaluate
the validation status of your process
- Assist
in identifying critical process parameters and designing appropriate
validation studies
- Apply
statistical methods to the evaluation of process validation data
- Assist
in preparing process validation related submissions to CBER
Facility
Validation
Biologics
Consulting Group, Inc. can also provide support in specific areas
of facility validation. Assistance with drafting, executing or auditing
IQs, OQs and PQs is available in the areas of:
- Equipment
Validation
- Utilities
Validation
- Cleaning
Validation
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