FDA – Page 294 – Pharma.Tips

Pet Failure at stability pull: risk assessment for sterility assurance

Analyzing Pet Failures During Stability Pulls: A Structured Investigation Approach In the highly regulated field of pharmaceutical manufacturing, stability testing is critical for ensuring the long-term safety and efficacy of…

Pet Failure after excipient change: process controls for moulding, filling, and storage

Addressing Process Control Challenges Following Excipient Changes to Prevent Pet Failure In the pharmaceutical manufacturing environment, a significant change to excipients can lead to unexpected challenges, including the risk of…

Viscosity Drift after excipient change: process controls for moulding, filling, and storage

Analyzing Viscosity Drift Following an Excipient Change in Pharmaceutical Manufacturing Viscosity drift represents a common challenge following an excipient change in pharmaceutical formulations, particularly for rectal and vaginal dosage forms.…

Em Excursion during PAI readiness: packaging integrity and CCIT justification

Assessing Em Excursion in PAI Readiness: Ensuring Packaging Integrity and CCIT Justification In the realm of pharmaceutical manufacturing, particularly within the context of ophthalmic dosage forms, maintaining packaging integrity is…

Phase Separation in vaginal gel production: process controls for moulding, filling, and storage

Investigation of Phase Separation in Vaginal Gel Production: Process Controls for Improved Quality In the production of vaginal gels, phase separation poses a significant challenge, impacting product quality and patient…

Melting Point Failure in suppository manufacturing: process controls for moulding, filling, and storage

Understanding Melting Point Failures in Suppository Manufacturing: A Comprehensive Investigation Approach In the realm of pharmaceutical manufacturing, particularly for dosage forms like suppositories, melting point failures can pose significant challenges.…

Ph Drift during cooling and moulding: process controls for moulding, filling, and storage

Addressing pH Drift during Cooling and Moulding: Control Strategies for Pharmaceutical Manufacturing pH drift during the cooling and moulding phases of pharmaceutical production can lead to significant quality control issues,…

Pet Failure during PAI readiness: FDA-ready investigation report and batch disposition

Addressing Pet Failure During PAI Readiness: A Comprehensive Investigation Approach In the world of pharmaceutical manufacturing, particularly within the realm of ophthalmic dosage forms, the readiness for Pre-Approval Inspection (PAI)…

Cooling Tunnel Variability after temperature excursion: process controls for moulding, filling, and storage

Addressing Cooling Tunnel Variability Following Temperature Excursions: An Investigative Approach In the pharmaceutical manufacturing landscape, maintaining stringent temperature control during production processes is crucial. Variability associated with cooling tunnels after…

Suppository Deformation after excipient change: CAPA with effectiveness checks for auditors

Addressing Suppository Deformation Following an Excipient Change: A Comprehensive Investigation Approach In the dynamic landscape of pharmaceutical manufacturing, changes in excipients can inadvertently trigger significant quality issues, such as suppository…

Em Excursion during routine EM trending: sampling, filtration, and EM controls

Investigation into Em Excursions During Routine Environmental Monitoring Trending Environmental Monitoring (EM) is critical for ensuring compliance with Good Manufacturing Practices (GMP) in pharmaceutical manufacturing, especially in sterile environments such…

Fill Weight Variability in suppository manufacturing: CAPA with effectiveness checks for auditors

Understanding and Addressing Fill Weight Variability in Suppository Production: A Comprehensive Investigation In the complex landscape of pharmaceutical manufacturing, fill weight variability in suppository production can undermine product quality and…