Quality Systems – Page 249

Pet Failure after supplier change: GMP documentation for FDA/EMA/MHRA review

Investigating Pet Failures Following Supplier Changes: Strategies for Compliance and Quality Assurance In the ever-evolving landscape of pharmaceutical manufacturing, the stability and efficacy of products are paramount. However, changes in…

Cpv Trending Gap during PAI readiness: how to document for FDA/EMA/MHRA review

Understanding Cpv Trending Gaps for Successful PAI Readiness Documentation Pharmaceutical manufacturing is a precise and regulated industry, and any deviations or out-of-specification (OOS) occurrences can lead to serious compliance issues…

Oos Release Profile for innovative delivery systems: how to document for FDA/EMA/MHRA review

Documenting OOS Release Profiles for Innovative Delivery Systems: An Investigation Approach for Regulatory Review In the landscape of pharmaceutical manufacturing, particularly for advanced and novel drug delivery systems, Out-of-Specification (OOS)…

API hygroscopicity-driven degradation after solvent change in last step: data integrity and chromatographic audit trail review steps

“` Investigating API Degradation Due to Hygroscopicity After Solvent Change in Final Production Step In pharmaceutical manufacturing, the integrity of active pharmaceutical ingredients (APIs) is paramount. An incident may occur…

Microbial Limits Failure during bulk hold: sanitation, water, and EM checks

Addressing Microbial Limits Failures during Bulk Hold: An Investigation Guide Microbial contamination can pose significant risks to pharmaceutical products, particularly during the bulk hold phase. When microbial limits fail, the…

Design Space Missing for modified release platforms: decision tree for lab vs manufacturing root cause

Identifying the Absence of Design Space in Modified Release Platforms: A Methodical Investigation Approach In the pharmaceutical manufacturing landscape, identifying a missing design space for modified release platforms can often…

Specification Justification Gap for modified release platforms: risk assessment and validation impact analysis

Addressing Specification Justification Gaps in Modified Release Platforms: An Investigative Approach In the complex world of pharmaceutical manufacturing, addressing specification justification gaps, particularly for modified release platforms, can pose significant…

Control Strategy Weakness for long-acting injectables: regulatory-ready investigation and CAPA plan

Investigation into Control Strategy Weaknesses for Long-Acting Injectables: A Regulatory-Ready Approach In the landscape of pharmaceutical manufacturing, control strategy weaknesses can disrupt the quality and efficacy of long-acting injectables, potentially…

API melting point / DSC anomaly during EU GMP inspection preparation: control strategy updates for CPPs/CMAs and continued process verification

Identifying and Addressing API Melting Point DSC Anomalies in EU GMP Inspection Preparation Pharmaceutical manufacturing is susceptible to various anomalies that can affect product quality. One such issue is the…

Ph Drift during method transfer: manufacturing vs lab root cause decision tree

Understanding pH Drift During Method Transfer: A Root Cause Investigation Framework In pharmaceutical manufacturing, one critical issue that can arise during method transfer is pH drift. This phenomenon can lead…

Crimp Diameter Variability at stability pull: FDA/MHRA inspection-ready documentation

Understanding Crimp Diameter Variability During Stability Pulls: An Investigation Framework Crimp diameter variability during stability pulls can pose significant challenges in pharmaceutical manufacturing, particularly for aerosol formulations. Variability in crimp…

Spray Pattern Failure in MDI assembly: FDA/MHRA inspection-ready documentation

Addressing Spray Pattern Failures in MDI Assembly: An Investigation Framework Within the pharmaceutical manufacturing landscape, especially in the realm of metered-dose inhalers (MDIs), ensuring consistent spray patterns is crucial for…