Quality Systems – Page 257

Ccit Failure during method transfer: FDA-ready investigation report and batch disposition

Ccit Failure During Method Transfer: An Investigation Framework for Pharma Professionals Failure in Cell Culture Infectivity Testing (CCIT) during method transfer can pose significant challenges in pharmaceutical manufacturing, especially within…

E&L Failure after backing material change: GMP investigation plan and CAPA

Devising an Effective GMP Investigation for E&L Failure Following Backing Material Change In the realm of pharmaceutical manufacturing, the integrity and efficacy of transdermal drug delivery systems hinge on meticulous…

Emulsion Inversion after packaging change: cleaning validation and worst-case selection

Understanding Emulsion Inversion Post-Packaging Change: A Comprehensive Investigation Emulsion inversion often presents a significant challenge in pharmaceutical manufacturing, particularly after a change in packaging materials or design. Such incidents can…

Drug Crystallization during EU/UK market supply: process parameter review and validation impact

Understanding Drug Crystallization Challenges in EU/UK Market Supply: A Process Parameter Review In the pharmaceutical industry, ensuring the stability and integrity of drug products is paramount, particularly during the supply…

Assay Oos in cream manufacturing: GMP investigation and CAPA strategy

Investigating Assay Out-of-Specification in Cream Manufacturing: A GMP Approach In the realm of pharmaceutical manufacturing, particularly within cream manufacturing, the identification of out-of-specification (OOS) results can lead to significant challenges.…

E&L Failure during lamination: inspection-ready documentation pack

Investigation of E&L Failure in Lamination: A Guide for Compliance and Quality Assurance Managing Extractables and Leachables (E&L) failures during the lamination process in pharmaceutical manufacturing is critical. Such failures…

Pet Failure during method transfer: FDA-ready investigation report and batch disposition

Investigation Report on Pet Failure During Method Transfer: Ensuring Compliance and Quality Assurance In the realm of pharmaceutical manufacturing, method transfers for ophthalmic dosage forms pose significant challenges. A recent…

Cleaning Validation Failure during bulk hold: how to document deviations for FDA/EMA

Understanding and Documenting Cleaning Validation Failures during Bulk Hold In the dynamic world of pharmaceutical manufacturing, ensuring compliance with cleaning validation protocols during bulk hold operations is crucial. A failure…

Packaging Dry-Out after adhesive change: process parameter review and validation impact

Investigating Packaging Dry-Out After an Adhesive Change: A Structured Approach In pharmaceutical manufacturing, the integrity and performance of packaging materials are critical to product quality. A recent deviation encountered during…

Phase Separation in ointment filling: complaint trending and risk-based actions

Investigating Phase Separation During Ointment Filling: A Problem-Solving Approach Phase separation in ointment filling can lead to significant quality failures and regulatory risks. When this issue arises, it not only…

E&L Failure during lamination: GMP investigation plan and CAPA

GMP Guidelines for Investigating E&L Failures During Lamination In pharmaceutical manufacturing, especially within transdermal drug delivery systems, extractables and leachables (E&L) failures during the lamination process can compromise product integrity…

E&L Failure at stability pull: sampling, filtration, and EM controls

Investigating E&L Failures During Stability Pulls: A Practical Guide In pharmaceutical manufacturing, especially when dealing with ophthalmic dosage forms, extracting the appropriate product for stability pulls is crucial to ensure…