Search results for " inspection"
Article
Efforts Accelerate to Streamline Postapproval Change Process
…ecycle to support continuous improvement, said Mahesh Ramanadham, acting director of the Division of Inspection Assessment in the Office of Process and Facilities (OPF), in the Center for Drug Evalua…
Article
Biopharma Advances Demand Specialized Expertise
This reorganization was designed to enhance quality drug assessment by realigning several elements of the preapproval and surveillance inspection process. Integrating risk-based review, GMP inspection…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Tainsh and Pugh cited, as an example of innovation, liquid dispensing with process analytical technologies (PAT), such as near infrared (NIR) inspection, ultraviolet (UV) solution analysis, droplet we…
Article
Maximum Output Starts with Optimized Upstream Processing
…nd the application of artificial intelligence to historically manual processes like automated visual inspection are all taking place at Pfizer.
Innovation in storage and distribution was evident …
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In addition, he notes that the filling process should be followed immediately by visual inspection and label and pack operations. “With this in mind, the size of a batch, which is processed in one run…
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Good Manufacturing Practices: Challenges with Compliance
Having an effective feedback loop from multiple sources, such as regulatory inspections and customer audits, makes it easier for companies to continuously improve their CGMP practices. I have also fou…
Article
Using Software in Process Validation
Quality cannot be adequately ensured merely by in-process and finished product inspection or testing. Validation must happen at each step of a manufacturing process, which involves lots of team member…
Article
Methods Accelerate Biosimilar Analysis
While similar species are present in both the innovator product and the biosimilar product, close inspection of peak intensities shows that the innovator product has greater enrichement of the G0F-Glc…
Article
Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
By Stuart Ward
…