Search results for " GMP"

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…

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…

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