Search results for " certificate of analysis"
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The approach also certifies quality of media in addition to tests provided on a vendor’s certificate of analysis (CoA) by continuously evaluating cell-culture media properties during release testing. …
Article
CoAs Help Secure the Supply Chain
The World Health Organization (WHO) has a document on their website titled, “Model Certificate of Analysis”. This document has a comprehensive list of information suitable to be included in a CoA. The…
Article
Best Practices in Qualification of Single-Use Systems
Key factors listed in the guidance document (7) include:
• “A supplier’s certificate of analysis can be used in place of performing other tests, provided that the manufacturer has a system in plac…
Article
Raw Material Variability
A New Approach
A certificate of conformance or certificate of analysis (CoA) is the current way of controlling quality; however, this way won’t do the job going forward. A more sophisticated …
Article
Setting Standards for Biotech Therapeutics in India
To establish these standards, candidate materials can be sourced from multiple Indian manufacturers (with certificate of analysis) and calibrated against the originator product. Development of referen…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Applying GMPs to the BioPharma Supply Chain
Comprehensive (and electronic) information and knowledge flow
Suppliers need to understand that product and process data over and above that shown on a certificate of analysis are needed by end us…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …