Process Validation Consulting
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. Count on Mangan Biopharm for Biopharmaceutical Process Validation.
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 in Life Sciences Validation Services.
Experienced
Mangan Biopharm has experienced professionals to assist you with your process validation needs. Whether it is 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
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.
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.
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
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
FAQ
Process validation is essential in life sciences to ensure that manufacturing processes consistently produce high-quality products. It provides documented scientific evidence that processes are reliable, controlled, and compliant with regulatory standards.
Process Validation Consulting helps organizations design, implement, and maintain validation programs aligned with industry regulations. It includes developing protocols, executing validation studies, and ensuring proper documentation throughout the process lifecycle.
Biopharmaceutical Process Validation typically includes process design, process qualification, and continued process verification. Each stage ensures that the process performs effectively from development through commercial production.
Organizations should consider Life Sciences Validation Services during new product development, process changes, scale-up activities, or regulatory audits to ensure compliance and consistent product quality.
Change control and assessments are crucial for maintaining validated states. They ensure that any modifications to processes, equipment, or systems are evaluated, documented, and approved without compromising product quality or compliance.