ARTICLES BY BIKASH CHATTERJEE
Navigating The FDA’s Emergency Use Authorization Process
The FDA has been authorized to grant Emergency Use Authorizations for SARS-CoV-2. This will impact both internal manufacturing and the CDMOs that drug sponsors employ.
Ensuring Quality In Ventilator Production Scale-Up For COVID-19
Chief Editor Louis Garguilo asked Outsourced Pharma Advisory Board member and COO/CSO of Pharmatech Associates, Inc., Bikash Chatterjee, to update our readers periodically on what he is seeing and experiencing during this coronavirus pandemic. This is his first update.
Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?
In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners.
Evaluating New FDA Draft Guidance: Qualification Process For Drug Development Tools
The FDA recently issued its draft guidance on the qualification process for drug development tools (DDTs), as part of the commitment mandated by the 21st Century Cures Act. The draft guidance provides a high-level description of the intent and content of the DDT program, but it does not address evidentiary standards or performance criteria for purposes of DDT qualification, leaving it to industry to propose the scientific argument and data package.
Understanding The FDA’s Knowledge-Aided Assessment & Structured Application (KASA) Framework
The FDA's Knowledge-Aided Assessment & Structured Application Framework marks an ambitious step forward in standardizing and increasing the efficiency of the drug review process. Here's what it will take for the framework to succeed.
Pharma 4.0: Building Quality Into Pharma Manufacturing, From Molecule To Medicine
A race is being run to create the pharmaceutical manufacturing of the future and with Pharma 4.0, powerful market trends are shaping the running field.
Analytical Testing Strategies For Clinical And Commercial Operations
A summary of a survey designed to better understand the factors considered when establishing an analytical-testing strategy for clinical-material release.
Considerations For Biologic Drug Substance And Drug Product Testing
While the FDA does not explicitly define the testing required as a product moves through its development life cycle, recognized standards provide guidance based upon where you are in your drug development and clinical program. This article focuses on the considerations for building a testing strategy for a drug product when using a CMO.
Pharma 4.0: A New Framework & Process For Digital Quality Management
Contrary to how it sounds, controlling information is not about withholding key documents or facts that are relevant to the CMO bidding process to see how the bidders react, or only supplying pertinent information if requested. In fact, it is exactly the opposite is true.
4 Key Considerations When Engaging A New GMP Contract Service Provider
This article explores what is important when establishing an effective relationship with a CSP as the program moves from product and process design to commercial manufacturing.
Examining FDA’s New Quality Agreement Guidance
FDA’s new guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements specifically addresses seven elements that should be included in a quality agreement: quality unit activities, facilities and equipment, materials management, product-specific considerations, laboratory controls, documentation, and change control.
FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)
In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.
Effective Risk Management: A Catalyst For Quality Performance
When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.