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

Page Updated: July 3, 2007