919-827-0933

Process Validation

“The collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Trust Worthy

The professionals at Mangan Biopharm are committed to delivering quality professional services to our clients.    Our clients trust us to provide not only technical expertise but also professional staff dedicated to project success.

Experienced

Mangan Biopharm has  experienced professionals to assist you with your process validation needs.  Whether its project support, program development, or staff augmentation, Mangan can help you achieve your goals.

Professional

Our staff understand the fundamental principle of our business, “clients make our business“.  Without our clients we would not exist; therefore, each of our employees consider professionalism a key attribute for good client relations.

What we Do

Process Validation Expertise

Policies & Procedures 

With much experience at several biopharm clients, we can benchmark your validation program against current industry standards or create a new custom program that fits your unique business model.

Project Execution

Sometimes new products or new processes create a gap in your resources and you need a trusted partner who can provide professional services to help fill that short term need.   Mangan Biopharm offers professional staff that have been instrumental in new product introductions and process validation at some of the largest biopharmaceutical companies in the world.

Change Control & Assessments

A critical component of a quality system is a robust change control process that incorporates a thorough risk assessment.  Mangan can help you perform process and product impact assessments to ensure the integrity of your product lifecycle is maintained. 

Resources

Helpful Resources for Process Validation

US FDA Process Validation Guidance

Current 2011 Guidance for Industry, Process Validation: General Principles and Practices

 

EMA Guideline on Process Validation

Guideline on process validation for finished products – information and data to be provided in regulatory submissions

World Health Organization Process Validation Guidance

Guidelines on Good Manufacturing Practices: Validation, Appendix 7: Non-Sterile Process Validation.

PIC/S Annex 15

Guide to Good Manufacturing Practices for Medicinal Products, Annex 15 Qualification and Validation

“Mangan delivers on their projects with talented resources and the technical know how to offer solutions to problems instead of waiting on us to solve them.  I appreciate their dedication and willingness to do what it takes.”

-Client A

“We had some unexpected challenges that consumed our internal resources at the same time a critical project was in progress.  Mangan stepped in and provided several validation engineers to fill the gap.  Great job guys!”

-Client B

“A trusted partner is often difficult to find.  With Mangan, we have been pleased with their responsiveness and overall quality of their staff.  What started as one small project has grown into a trusted partnership.. “

-Client C

Contact Us

If we can help you in any way, please complete the  More Information form and one of our specialists will contact you to discuss your specific needs and how Mangan can help you achieve your project goals.

West Region

trahimian@manganinc.com

(310) 835-8080 Ext. 217

3901 Via Oro, Long Beach, CA 90810

Eastern and Midwest Regions

mtedder@manganinc.com

(919) 827-0933

201 Shannon Oaks Circle Suite 125 Cary, NC 27511

For More Information: