Search results for " review"
Article
Operational Excellence: More Than Just Process Improvement
Compliance specialists were created to rotate through the operations area and to spend 80% of their time on the shop floor to provide real-time, in-process batch record documentation review and mentor…
Article
Essentials in Quality Risk Management
Risk communication and review
Once the risk assessment and the control actions have been determined, it is crucial in the QRM process to communicate the actions to p…
Article
QbD and PAT in Upstream and Downstream Processing
The risk assessment includes a review and assessment of the products CQAs when manufactured on specific equipment.
BioPharm: In implementing QbD, what would you identify as the critical process …
Article
PDA's Technical Report for Biotech Cleaning Validation
49 include change control, risk-based periodic monitoring, and data trending review. Training and retraining for manual cleaning processes are also significant because they are the primary mechanisms …
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Article
How To Execute Successful Data Migrations
Assign experienced QA resources to review and test business and technical requirements.
Have QA resources work in tandem with business analysts to review detailed transformation/mapping s…
Article
Reimagining Affordable Biosimilars
A review of biosimilars approved in the past five years suggests increasing use of rodents followed by NHPs for PK studies and mice for PD studies (25) (see Table II). When the target antigen of the b…
Article
Good Manufacturing Practices: Challenges with Compliance
Do a thorough review, not only of the requirements set out by FDA and other regulatory bodies, but also the World Health Organization’s comprehensive set of annexes related to biological products.
…
Article
The Importance of Partnering for Bioanalytical Studies
These involve a lot of experimentation, data curation and storage, quality review, personnel training, generation of SOPs, etc.—all related documentation should be available for review by FDA, along w…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
This review focuses on how different modeling strategies can be leveraged to aid in product QA across the different stages of biopharmaceutical product development and manufacture. Technical details o…