EMA – Page 159 – Pharma.Tips

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…

Finished product serialization data mismatch after process parameter adjustment: data integrity review steps for LIMS/EMR/ES and chromatography systems

“`html Addressing Serialization Data Mismatches Following Parameter Adjustments in Pharmaceutical Processes In the complex landscape of pharmaceutical manufacturing, maintaining data integrity is crucial, especially during serialization processes. Observations of mismatched…

Cross-contamination risk during inspection prep: FDA/EMA investigation expectations

Assessing Cross-Contamination Risks During Inspection Preparation: Expectations for FDA and EMA Investigations The prevalence of cross-contamination during pharmaceutical inspection preparations is an enduring concern for compliance, quality control, and ultimately,…

Adhesion Failure during scale-up: inspection-ready documentation pack

Dealing with Adhesion Failures During Scale-Up: A Comprehensive Investigation Guide In the world of pharmaceutical manufacturing, particularly in the development of transdermal drug delivery systems, adherence to quality is non-negotiable.…

Finished product blend uniformity failure during line clearance and changeover: how to build a deviation package that passes an inspection deep-dive

How to Effectively Address Blend Uniformity Failures During Line Clearance in Pharmaceutical Manufacturing The detection of finished product blend uniformity failures during crucial processes such as line clearance and changeover…

Occupational exposure limit breach in oncology manufacturing: FDA/EMA investigation expectations

Addressing Breaches of Occupational Exposure Limits in Oncology Manufacturing: A Comprehensive Investigation Framework Incidents involving breaches of occupational exposure limits (OELs) in oncology manufacturing can pose significant challenges to compliance,…

Coating Weight Variability during scale-up: root cause mapping across materials and process

Root Cause Investigation of Coating Weight Variability in Scale-Up Processes Coating weight variability during scale-up can lead to significant product quality issues and regulatory challenges. As pharmaceutical manufacturers expand their…

Finished product content uniformity OOS after packaging material change: FDA-compliant investigation flow and batch disposition decision tree

Addressing Out-of-Specification Content Uniformity in Finished Products Following a Packaging Material Change In the pharmaceutical industry, ensuring the quality and consistency of finished products is paramount. One common issue arises…

Stability failure after equipment cleaning: risk assessment for patient safety

Understanding Stability Failures Post-Equipment Cleaning: A Risk Assessment Framework In the realm of pharmaceutical manufacturing, stability failures can pose significant risks not only to product quality but also to patient…

Dose Delivery Variability after adhesive change: root cause mapping across materials and process

Mapping the Root Causes of Dose Delivery Variability Following an Adhesive Change In the realm of pharmaceutical manufacturing, any variability in dosage delivery can have significant implications. A recent incident…