Search results for " documentation"
Resource
EMA scientific guidance documents on biosimilar medicines
This page lists the scientific guidance documents on biosimilar medicines from EMA.
Resource
FDA Guidance Documents
A searchable database of FDA guidance documents
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Avoiding Investigational Failures and Discrepancies
EQMS: The key to avoiding investigational failures and discrepancies
An organization’s ability to integrate data and documentation from investigations with the rest of the company’s overall …
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
…dge and ultimately link to the protection of the patient
• The level of effort, formality, and documentation of the quality risk management should be commensurate with the level of the risk.
…
Article
Understanding Validation and Technical Transfer, Part I
Understanding Validation and Technical Transfer, Part I
This is the first of a series of three articles about validation and technical transfer in the bio-pharmaceutical industry. Part 1 || Part 2 |…
Article
GMP Challenges for Advanced Therapy Medicinal Products
The availability of these in high-quality grades was limited because they were mainly sold “for research use only” and were accompanied by little product documentation from the suppliers, according to…
Article
Design and Qualification of Single-Use Systems
• Documentation should also be considered as part of product design, to include support data for performance claims, design and production validation data reports, operation guides, and other informat…
Article
Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.
By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…
Article
Using Software in Process Validation
For instance, these systems can deliver clear documentation, provide version control for the multitude of systems in use, and perform backup to ensure all risks are mitigated.
Software systems …