MHRA – Page 190 – Pharma.Tips

E&L Failure at stability pull: risk assessment for sterility assurance

Assessing and Investigating Risks Associated with E&L Failure at Stability Pull The detection of extractables and leachables (E&L) failures during stability pulls represents a significant challenge for pharmaceutical manufacturers, particularly…

Ph Drift at accelerated stability: packaging integrity and stability justification

Investigation into pH Drift during Accelerated Stability Testing: Assessing Packaging Integrity and Stability Justifications In the realm of pharmaceutical manufacturing, deviations during stability testing can pose significant challenges. One such…

Packaging Leakage Complaint at accelerated stability: CAPA with effectiveness checks for auditors

Addressing Packaging Leak Complaints in Accelerated Stability Testing: A Structured Investigation Approach In pharmaceutical manufacturing, the integrity of packaging is critical for ensuring product efficacy and safety. A complaint regarding…

Content Uniformity Failure in vaginal gel production: GMP investigation and batch disposition

Investigating Content Uniformity Failures in Vaginal Gel Production Content uniformity failures in vaginal gel production can pose serious challenges in ensuring product quality and regulatory compliance. This article aims to…

Sterility Test Failure during routine EM trending: how to avoid repeat 483 observations

Sterility Test Failures: Investigation Strategies to Prevent Repeating 483 Observations Sterility test failures during routine environmental monitoring (EM) trending are critical issues that can result in regulatory scrutiny, including 483…

Suppository Deformation at accelerated stability: CAPA with effectiveness checks for auditors

Investigating Suppository Deformation During Accelerated Stability Testing: An Effective CAPA Approach The occurrence of suppository deformation at accelerated stability testing can pose significant challenges in pharmaceutical manufacturing and quality assurance.…

Suppository Deformation in suppository manufacturing: GMP investigation and batch disposition

Analyzing Suppository Deformation Issues in Manufacturing: A GMP Investigation Approach In the pharmaceutical manufacturing sector, particularly for rectal dosage forms like suppositories, the integrity of the final product is critical…

Fill Volume Variability during PAI readiness: packaging integrity and CCIT justification

Understanding Fill Volume Variability During PAI Readiness: Ensuring Packaging Integrity and CCIT Justification Fill volume variability can pose significant challenges in pharmaceutical manufacturing, particularly during the Process Analytical Technology (PAT)…

Viscosity Drift during inspection readiness: CAPA with effectiveness checks for auditors

Managing Viscosity Drift During Inspection Readiness: Practical CAPA for Pharma Professionals In the pharmaceutical manufacturing landscape, the challenge of viscosity drift can pose significant questions during inspection readiness. When viscosity…

Cooling Tunnel Variability during inspection readiness: packaging integrity and stability justification

Investigating Cooling Tunnel Variability: Ensuring Packaging Integrity and Stability Justification In the pharmaceutical manufacturing environment, maintaining optimal conditions during the cooling process is critical. Recent observations of variability in cooling…

Cooling Tunnel Variability during bulk hold: packaging integrity and stability justification

Investigating Cooling Tunnel Variability During Bulk Hold: Ensuring Packaging Integrity and Stability The unexpected variability in cooling tunnel operations during the bulk holding phase can pose significant risks to the…

Osmolality Oos for multi-dose products: sampling, filtration, and EM controls

Investigating Osmolality OOS in Multi-Dose Ophthalmic Products: A Structured Approach In the pharmaceutical manufacturing landscape, deviations such as out-of-specification (OOS) results for osmolality in multi-dose ophthalmic products can pose significant…