Regulatory Guidance Links
US Food & Drug Administration
2. Title 21 Electronic Code of Federal Regulations
4. Recent Final Medical Device Guidance Documents
5. Recent Draft Medical Device Guidance Documents
6. Guidance, Compliance & Regulatory Information (Biologics)
7. Guidance for Industry (Animal & Veterinary)
Hot Topics
European Medical Agency
Health Product Regulatory Authority (HPRA)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Pharmaceutical Inspection Co-operation Scheme (PIC/S)
World Health Organization (WHO)
What we Do
Validation and Automation Expertise
Policies & Procedures
With much experience at several biopharm clients, we can benchmark your programs 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 project execution 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.
Special Topics
The following section contains links to guidance on special topics including Process Validation, Computer Systems Validation, Data Integrity, Cleaning Validation, and Good Distribution Practice.
Process Validation
2. Guideline on process validation for finished products – information and data to be provided in regulatory submissions. European Medicines Agency
3. Guidelines on Good Manufacturing Practices: Validation, Appendix 7: Non-Sterile Process Validation. WHO Expert Committee on Specifications for Pharmaceutical Preparations
4. Guide to Good Manufacturing Practices for Medicinal Products, Annex 15 Qualification and Validation. PIC/S PS/INF 11/2015
Computerized Systems Validation
2. EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines, Annex 11: Computerized Systems
3. Good Practices For Computerised Systems in Regulated “GXP” Environments. PIC/S Guidance PI 011-3
4. Guidelines on Validation – Appendix 5 Validation of Computerized Systems (Draft for Comments). WHO Working Document QAS/16.667
Data Integrity
Cleaning Validation
Good Distribution Practice
1. Good Distribution Practice of Medicinal Products for Human Use. European Commission Guidelines of 5 November 2013
2. Principles of Good Distribution Practice of Active Substances for Medical Products for Human Use. European Commission Guidelines of 19 March 2015.
3. PIC/S Guide to Good Distribution Practice for Medicinal Products. PIC/S June 2014
4. Supply Chain Security Toolkit. Asia-Pacific Economic Cooperation (APEC)
“Mangan delivers on their projects with talented resources and the technical know how to over solutions to problems instead 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.. “