Search results for "regulatory"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Cleaning validation regulatory guidance
FDA’s 1998 cleaning validation guidance document focuses on general aspects and qualification of the cleaning process (1). The design and post-validation mo…
Article
Witnessing Major Growth in Next-Generation Antibodies
Additional analytical and regulatory demands
Next-generation antibodies also have their own set of analytical and regulatory challenges. With respect to analytical methods, each format/target comb…
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Real Time Continuous Microbiological Monitoring
In addition, the pharmaceutical industry has been called upon to continually raise its sterility assurance standards through ongoing increased global regulatory standards, especially over the past 10 …
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Microbiological Testing: Time is of the Essence
“Occasionally the therapeutic molecule can have toxic effects on the detector cells that are used to detect viruses in in-vitro assays that comply with ICH Q5A (1) and related regulatory guidelines,” …
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Biosimilars: Making the Switch Comes with Challenges
The assessment of the comparisons between the physicochemical and functional data of a biosimilar with its reference product now corresponds with the regulatory assessment made between a new manufactu…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
The methods are well suited for routine use in the quality-control environment and the provided identification approach meets CFR, FDA, and other regulatory agencies requirements. As part of this appr…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
With the plethora of regulatory guidelines and associated compliance requirements to adhere to when building a facility, it must be clear whether the product is for research and development purposes (…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
The guidance states that the ETT will “facilitate regulatory review of new manufacturing technology in accordance with existing legal and regulatory standards, guidance, and Agency policy related to q…
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Selecting the Right Viral Clearance Technology
Because viral clearance studies are typically outsourced, particularly by smaller companies, these data are often not generated until they are needed to support a regulatory submission. “One common pi…
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Best Practices in Qualification of Single-Use Systems
Regulatory Requirements
For finished pharmaceuticals, FDA has issued regulations explaining cGMPs in 21 Code of Federal Regulations (CFR) 210 and 211 (5, 6). For APIs or drug substances, however, …