PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
|Articles|March 2, 2016
- Pharmaceutical Technology-03-02-2016
- Volume 40
- Issue 3
Mixing Systems for Rehydration and Mixing Applications
The QuaDrum rigid outer containers (ROCs) from Meissner are used for rehydration and mixing applications. The retaining lid, stainless steel dolly, and bottom drain allow recirculation-based mixing for process volumes between 50 L and 200L. The retaining lid for mixing applications provides access to fluid paths located on the top of the biocontainer and can positively locate and support a 3-inch TC port on top of the biocontainer. This port can be used for powder addition or other operations that require large bore access to the biocontainer. The stainless-steel dolly, which is required to facilitate bottom drain applications, can be specified with swivel wheels that lock for added security.
Articles in this issue
over 10 years ago
Gaining Insight from Process Control Dataover 10 years ago
Phase-Appropriate GMPover 10 years ago
How Important is Data Integrity to Regulatory Bodies?over 10 years ago
FDA GDUFA Testimony Presentation Slidesover 10 years ago
Keynote Series Addresses Crucial Industry Issuesover 10 years ago
Polymorph Screening for Identification of Relevant Crystalline Formsover 10 years ago
Building Consensus for E&L Testing Standardsover 10 years ago
Multimode Microplate Reader Improves SensitivityRelated to this article
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
Trending on Pharmaceutical Technology
1
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
2
FDA's IND Pilot Puts CMC Review First
3
Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs
4
Mature Medicines Divestment Signals Shift in Manufacturing Strategy
5