FDA – Page 291 – Pharma.Tips

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…

Pet Failure in suppository manufacturing: GMP investigation and batch disposition

GMP Investigation of Pet Failure in Suppository Manufacturing: A Comprehensive Approach Pharmaceutical manufacturing is a complex process requiring stringent adherence to Good Manufacturing Practices (GMP). A deviation in suppository production,…

Cooling Tunnel Variability after temperature excursion: manufacturing vs lab root cause decision tree

Understanding Cooling Tunnel Variability After Temperature Excursion: A Root Cause Investigation Approach The integrity of pharmaceutical manufacturing processes is paramount, particularly when ensuring consistent product quality and compliance with regulatory…

Particulate Matter Oos at stability pull: sampling, filtration, and EM controls

Addressing OOS for Particulate Matter at Stability Pull: An Investigation Framework In quality-driven environments like pharmaceutical manufacturing, deviations such as Out of Specification (OOS) results for particulate matter during stability…

Melting Point Failure in vaginal gel production: CAPA with effectiveness checks for auditors

Investigation of Melting Point Failures in the Production of Vaginal Gels: A CAPA Approach The pharmaceutical manufacturing industry continuously faces challenges in ensuring product quality and compliance with regulatory standards.…