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.”
“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!”
“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.. “