Search results for " GMP"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
Automation, process integration, closed-system design, and compliance with current GMP can all be used to safeguard cell-therapy product quality.
Regulatory guidelines issued by FDA and other r…
Article
The Outlook for CMO Outsourcing in 2019
Growth and trends in outsourcing of microbial work remain omewhat unclear, with the largest CMO market, the United States, relatively lacking in microbial CMOs and GMP capacity greater than 100–200 L;…
Article
Leveraging Data for Better Biopharmaceutical Process Control
There are accounts of in-situ and at-line under GMP conditions use of different spectroscopies (2,3).
Currently, we are observing a trend toward connecting process condition-monitoring to accur…
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…
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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…
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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…
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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…
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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…