Search results for " GMP" in Articles / App Notes
Article
CoAs Help Secure the Supply Chain
Can you explain what should be on CoAs and how they relate to GMP compliance?
A. The International Pharmaceutical Excipients Council defines a CoA as “a legal document that certifies the…
Article
Industry Adoption of Single-Use Systems Remains Low
…ally automated, flexible biomanufacturing platform based on single-use technologies, that allows for GMP manufacturing. The acquisition complemented Cytiva’s portfolio with production-scale bioreacto…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning in the GMP industry is a critical process intended to prevent or, in more modern terms, reduce risk of contaminating the subsequent product with undesirable residues that may impact patient s…
Article
Drug Quality Key to Innovation and Access
…r retailers) is responsible for ensuring that drug substances and drug products are produced to meet GMP standards and how written agreements should map out the roles and responsibilities of each par…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…to be adequately addressed by the manufacturers and deeply reviewed by regulatory authorities during GMP inspections.
References
1. ICH, Q9 Quality Risk Management (ICH, Nov. 9, 2005).
2.…
Article
Aseptic Processing: Keeping it Safe
Although packaging failures factored into a majority of the “lack of sterility assurance” cases, many of the remaining contamination cases were associated with GMP issues or manufacturing errors such …
Article
Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
Article
Securing the Single-Use Supply Chain
…-ReadyToProcess with Cytiva, which is that their use is analogous to outsourcing crucial elements of GMP operations, such as presterilization. “The role of the supplier is therefore now more critical…
Article
Continued Process Verification for Biopharma Manufacturing
Some elements of CPV overlap with existing GMP systems such as the generation of data for batch release (BR) decisions, annual product review (APR), and change control.
In general, the nature and …
Article
FDA Seeks Metrics to Define Drug Quality
FDA is seeking new strategies to spur compliance with GMPs and to limit drug production errors that lead to supply problems, Woodcock explained at a July 10, 2013 seminar on “Understanding cGMPs” spon…