Investigation – Page 38

Assay drift after equipment cleaning: FDA/EMA investigation expectations

Addressing Assay Drift Post Equipment Cleaning: Investigation Best Practices Assay drift following equipment cleaning can pose significant challenges in pharmaceutical manufacturing, particularly in oncology products. An observed variance in assay…

Finished product CCIT failure after process parameter adjustment: CAPA plan that inspectors accept (with effectiveness checks and due dates)

Investigating Finished Product CCIT Failure Following Changes in Process Parameters In pharmaceutical manufacturing, the integrity of finished products is paramount to ensure both compliance and patient safety. A common issue…

Potency OOS during stability pull: FDA/EMA investigation expectations

Deviations in Potency OOS During Stability Pull: Investigation and Resolution Strategies In the highly regulated pharmaceutical sector, especially within oncology product manufacturing, the discovery of Out-of-Specification (OOS) potency results during…

Finished product assay OOS during PAI / FDA inspection readiness: updates to master batch record and in-process controls to prevent recurrence

Deviations in Finished Product Assay During PAI: Strategies for Inspection Readiness and Improvement During a recent Pre-Approval Inspection (PAI), a finished product assay was flagged as Out of Specification (OOS).…

Assay drift during shared facility campaign: FDA/EMA investigation expectations

Understanding Assay Drift During Shared Facility Campaigns: Investigation Framework for Regulatory Compliance Assay drift can pose significant challenges during shared facility campaigns, especially in an environment where cross-contamination might occur.…

Packaging Dry-Out during scale-up: root cause mapping across materials and process

Investigating Packaging Dry-Out During Scale-Up: Effective Root Cause Mapping in Pharma In the pharmaceutical manufacturing industry, particularly when scaling up transdermal drug delivery systems, unexpected phenomena such as packaging dry-out…

Finished product particulate matter OOS after method transfer to a new QC lab: stability strategy adjustments and packaging risk mitigation steps

Investigative Approach to Addressing OOS Results for Finished Product Particulate Matter After QC Lab Method Transfer In the pharmaceutical manufacturing landscape, the transfer of analytical methods to a new Quality…

Potency OOS in oncology manufacturing: risk assessment for patient safety

Understanding Potency OOS in Oncology Manufacturing: A Comprehensive Investigation Approach In the dynamic landscape of oncology manufacturing, ensuring the potency of pharmaceutical products is critical for patient safety and product…

Adhesion Failure during die-cutting: process parameter review and validation impact

Understanding Adhesion Failure during Die-Cutting: A Comprehensive Investigation Adhesion failure during die-cutting in pharmaceutical manufacturing can lead to significant product quality issues, especially in transdermal drug delivery systems. Such failures…

Finished product hardness / friability drift after packaging material change: manufacturing vs lab root cause mapping and required evidence

Investigation of Finished Product Hardness and Friability Drift After Packaging Material Change Variability in finished product hardness or friability can pose significant challenges in pharmaceutical manufacturing, especially following a change…

Occupational exposure limit breach in oncology manufacturing: risk assessment for patient safety

Investigating Breaches of Occupational Exposure Limits in Oncology Manufacturing In the realm of oncology manufacturing, maintaining stringent control over occupational exposure limits (OELs) is vital for ensuring the safety of…

Backing Delamination during lamination: root cause mapping across materials and process

Mapping the Root Causes of Backing Delamination During the Lamination Process Backing delamination is a critical issue encountered in the pharmaceutical manufacturing of transdermal drug delivery systems. It can lead…