Search results for " report" in Articles / App Notes
Article
Assessing Manufacturing Process Robustness
…lytical results
annual product quality review outcomes
investigation reports
product recalls
field alert report
product…
Article
Successfully Moving Regulated Data to the Cloud
…data captured in a paper record, electronic systems can be configured to provide automatic alerts or reports to highlight deviations from a defined workflow. This is in addition to the time saving th…
Article
Biopharma Takes a Nervous Glance Over Its Shoulder
This prediction is the focus of a new report, The U.S. Biopharmaceutical Industry: Perspectives on Future Growth and The Factors That Will Drive It, published by Battelle and the Pharmaceutical Resear…
Article
Drugs, At What Cost?
In a new report, The Global Use of Medicines: Outlook through 2017, IMS Institute for Healthcare Informatics projects that in 2014 total global spending on medicines will, for the first time, exceed $…
Article
The Importance of Partnering for Bioanalytical Studies
For immunogenicity assays, a statistical report or summary is required to justify your cut point(s). A well-described validation plan detailing the experiments and a priori acceptance criteria should …
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
…ised at the critical, late-stage fill/finish process, according to BioPlan Associates’ 14th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (2).
The advancemen…
Article
Managing Biomanufacturing Capacity Expectations
According to a report compiled by Patheon, ORC International, and PharmSource, demand and capacity forecast inaccuracies have prompted biopharmaceutical companies to embrace the use of outsourcing wit…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Results from BioPlan Associates’ 12th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) offer some clues as to what CMOs are doing to remain competitive.
CMOs…
Article
CMOs Concerned With Cost of Single-Use Equipment
By comparison, close to three-quarters reported being satisfied with the quality of the products (see Figure 2).
Figure 2: Percentage point gap between importance of single-use systems (SUS) produ…
Article
Best Practices in Qualification of Single-Use Systems
PDA
Technical Report No. 66, Application of Single-Use Systems in Pharmaceutical Manufacturing, has been developed to provide comprehensive, high-level guidance about qualification of SUS (1). This …