Search results for " guidelines"
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Efforts Accelerate to Streamline Postapproval Change Process
WHO recently issued guidelines on procedures and data requirements for changes to approved vaccines (4). The agency also is developing guidelines for dealing with variations in prequalified products, …
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EMA Invites Comments on New Guidance for Vaccine Development
The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical req…
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Good Manufacturing Practices: Challenges with Compliance
While generally easy to understand, the interpretation of the guidelines, especially when there is room for flexibility, can create the potential for challenges.
Having an effective feedback loo…
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Emerging Therapies Test Existing Bioanalytical Methods
The May 2018 FDA Bioanalytical Method Validation (BMV) Guidance for Industry (2) provides general guidelines for all bioanalytical assays but lacks any specifics on assays that use flow cytometry, PCR…
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A Look into the Future of Biopharmaceutical Quality
BioPharm: Are there regulatory guidelines in development for ensuring the quality of biologics in the future?
Newcombe (PAREXEL): There is no indication that the current, published quality guid…
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Understanding Validation and Technical Transfer, Part I
A few simple guidelines will help to simplify validation planning and execution:
• Define the inputs, the processing system, and the expected outputs.
• Don’t get bogged down in termino…
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Roadmap Leads to Innovative Biomanufacturing Strategies
… and commercialize new technologies; and regulators ensure that new advancements conform to existing guidelines or develop new guidelines in collaboration with industry, if required. Thus it is impor…
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Evaluating Surface Cleanliness Using a Risk-Based Approach
Health Canada, Guide-0028 Cleaning Validation Guidelines (Jan. 2008).
3. PIC/S, PE-006-3 Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning…
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Managing Residual Impurities During Downstream Processing
…ed means of monitoring--have, however, been key drivers for the continued review and optimization of guidelines for the manufacture of biologic drugs, according to Ashleigh Wake, director of biologic…
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Biosimilars: Making the Switch Comes with Challenges
This legislation has since been supplemented by an overarching guideline on standards for quality, safety, and efficacy of the products, which has been followed by a series of guidelines on class-spec…