MHRA – Page 193 – Pharma.Tips

Sterility Test Failure after packaging change: sampling, filtration, and EM controls

Sterility Testing Failures Following Changes in Packaging: A Comprehensive Investigation Framework A sterility test failure after a packaging change can pose significant risks in pharmaceutical manufacturing, particularly for sensitive products…

Microbial Limits Failure during cooling and moulding: packaging integrity and stability justification

Investigation of Microbial Limits Failure During Cooling and Moulding: Ensuring Packaging Integrity and Stability Correctly Justified In pharmaceutical manufacturing, particularly within the realm of rectal and vaginal dosage forms, microbial…

Fill Weight Variability in vaginal gel production: manufacturing vs lab root cause decision tree

Addressing Fill Weight Variability Issues in Vaginal Gel Production: An Investigation Framework In pharmaceutical manufacturing, fill weight variability can lead to significant quality concerns, especially in sensitive dosage forms like…

Packaging Leakage Complaint during cooling and moulding: process controls for moulding, filling, and storage

Addressing Packaging Leakage Complaints during Cooling and Moulding: A Comprehensive Investigation Framework In the pharmaceutical manufacturing landscape, packaging integrity is crucial to ensuring product quality and compliance with regulatory standards.…

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)…