Search results for " regulations"
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Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…
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Advancing QbD in the EU
Introducing them in regulations and guidelines gives more emphasis to the important elements in quality assurance.
"The adoption of ICH Q8–10 is not introducing new requirements or expectations…
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Cell-free Expression Systems Pose Cell Culture Alternative
“New technologies are therefore needed, in addition to potential changes to regulations, to adapt to the real-time release paradigm that cell-free biomanufacturing enables,” Rao adds. He compares the …
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Genetic Vaccine Platforms Demonstrate Their Potential
“Our expectation is that both technology regulations and platform regulations will evolve over the next several years,” says a company spokesperson from Janssen Infectious Diseases & Vaccines.
…
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Reimagining Affordable Biosimilars
EMA regulations do not require animal immunogenicity studies, while FDA and several other regulatory agencies require preclinical results prior to initiating clinical trials (28).
Table II.…
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ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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Eliminating Residual Impurities Starts with a Strategic Plan
Many regulations
There are several relevant regulations that address the identification and evaluation of residual impurities. The International Council for Harmonization (ICH) Q6B guideline …
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Emerging Therapies Test Existing Bioanalytical Methods
Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex thera…
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CoAs Help Secure the Supply Chain
The European regulations require that “Authentic Certificates of Analysis should be issued for each batch ….” (4).
The veracity of the CoA, however, still needs to be confirmed by the purchaser…
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Avoiding Investigational Failures and Discrepancies
By Walt Murray, James Jardine
Investigations-focused regulatory standards that apply to life-sciences organizations, such as FDA 21Code of Federal Regulations (CFR) 211.192, mand…