Search results for " guideline" in Articles / App Notes
Article
Efforts Accelerate to Streamline Postapproval Change Process
The aim is to encourage greater use of these protocols to reduce change reporting as part of the Q12 guideline.
A particularly tricky issue is how to apply the Q12 framework to already marketed pr…
Article
EMA Invites Comments on New Guidance for Vaccine Development
The new modular guideline is intended to cover and update in one single, consolidated document the existing guidance on regulatory, quality, non-clinical and clinical aspects of the development of all…
Article
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…
Article
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…
Article
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…
Article
Understanding Validation and Technical Transfer, Part I
FDA’s 1987 process validation guideline defined validation as “Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product me…
Article
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…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Selection of sampling sites
The European Union GMP guideline, Annex 15 section 10.11, cites that cleaning validation protocols should specify or reference the locations to be sampled, specify t…
Article
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…
Article
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…