Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|April 2, 2005
- Pharmaceutical Technology-04-02-2005
- Volume 29
- Issue 4
Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
The validation of alternative microbiological testing is an opportunity for a manufacturer to decrease the amount of time required for laboratory results.To properly validate these alternatives, a practitioner must first identify what is being studied. The regulatory effect on established product and process specifications and levels must be completely evaluated, as changing the method of analysis may well change the pparent number in the sample.
Advertisement
Articles in this issue
over 21 years ago
April 2005over 21 years ago
Management Controls for GMP Complianceover 21 years ago
PAT and Process Understanding: A Call to Armsover 21 years ago
Cold Chain Concernsover 21 years ago
Evolutions in Direct Compressionover 21 years ago
X-ray Microtomography of Solid Dosage Formsover 21 years ago
Orient ExpressAdvertisement
Related to this article
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Sanofi will transfer 20 mature medicines and three manufacturing sites to Cheplapharm for a 26.4% equity stake, closing by Q3 2027.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
Risk-Based Life Cycle Management of Master Production and Control Records to Strengthen Data Integrity and GMP Inspection Readiness Part 2: Practical Considerations for CGMP Documentation Systems
2
PharmTech’s Weekly Roundup—September 25, 2026
3
CPHI Milan: USP Benchmarks Reshape Procurement Incentives
4
PharmTech AI Pulse Check: Validating Multi-Agent Systems, OCR Models in GxP
5