Search results for " guidelines" in Articles / App Notes
Article
The Lifecycle Change of Process Validation and Analytical Testing
The implementation of the new FDA guidelines on process validation will not only meet the expectations of the regulator but can also ensure the success of business demands such as lean scale-up, comme…
Article
Eliminating Residual Impurities Starts with a Strategic Plan
Specific factors to assess for possible impurities include requirements established in regulatory guidelines, acute and chronic toxicity, risk of co-purification, and natural occurrence in humans, acc…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
To date, compliance levels and the impact of reporting guidelines to improve study reproducibility have been disappointing (28), but multidisciplinary efforts continue to promote transparency, opennes…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…utical equipment is essential to reduce the risk of product contamination and, as stated in relevant guidelines and as recognized by the pharmaceutical sector, this can be achieved only if the cleani…
Article
Host-Cell Protein Measurement and Control
Regulatory Requirements for HCPs Measurement and Control
According to International Conference on Harmonization (ICH) guidelines Q6B, “For host-cell proteins, a sensitive assay (e.g., immunoassay,…
Article
Assessing Manufacturing Process Robustness
…uncil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Harmonised Guidelines. ICH guidelines Q8–Q12 (1–5) and those in development such as ICH Q14 (6) have applied …
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
Impurity Testing of Biologic Drug Products
…SGS): The main document used by anyone characterizing a therapeutic protein remains the ICH Q6B guidelines (4). Now these guidelines are a little outdated, mainly with regards to biophysical methods …
Article
GMP Challenges for Advanced Therapy Medicinal Products
By Sean Milmo
A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene- and cell-therapy products and tissue-…
Article
Track-and-Trace Progress Benefits Supply-Chain Security Efforts
New implementation guidelines
In April 2021, GS1 US issued a new implementation guideline (3), emphasizing best practices for maintaining chain of custody.This practice is particularly important f…