Search results for " guidance" in Articles / App Notes
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Topics covered include:
1:33 – Key regulatory guidelines for biopharma companies to follow
3:00 - Recent guidance changes/additions that impact biopharma
3:37 - Areas where additiona…
Article
Best Practices in Qualification of Single-Use Systems
66, Application of Single-Use Systems in Pharmaceutical Manufacturing, has been developed to provide comprehensive, high-level guidance about qualification of SUS (1). This paper focuses on technical …
Article
Good Manufacturing Practices: Challenges with Compliance
For example, it is straightforward to complete gap assessments and ensure procedures align with the various laws, guidances, and technical publications that make up current CGMPs.
However, the s…
Article
The Importance of Partnering for Bioanalytical Studies
FDA has issued guidance documents detailing the scope of bioanalytical method validation required for PK/PD endpoints, but it is also important to consider other regional guidance documents (e.g., Eur…
Article
Understanding Validation and Technical Transfer, Part I
Subsequent revisions to US and international regulations and guidance documents stressed the need for process validation and quality management systems to ensure pharmaceuticals and biopharmaceuticals…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
Article
Managing Residual Impurities During Downstream Processing
“As biologic manufacturing and biologic product knowledge continue to expand, there will be a constant requirement to adapt and amend both thought processes and guidance,” Wake states.
Role of publ…
Article
Efforts Accelerate to Streamline Postapproval Change Process
To spur the Q12 process, FDA in 2015 issued a draft guidance on defining and reporting ECs (2). The guidance describes which elements of a control strategy could be considered ECs necessary to assure …
Article
The Metrics of Quality Culture
Schniepp
The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July 28, 2015. The official title of this guidance for industry is Request f…