MHRA – Page 211 – Pharma.Tips

Microbial Limits Failure after supplier change: investigation flowchart aligned to GMP

Conducting an Investigation into Microbial Limits Failure following Supplier Change Changes in suppliers can significantly impact microbial limits within pharmaceutical manufacturing processes. When a microbial limits failure arises after a…

Homogeneity Failure during bulk hold: manufacturing vs lab root cause decision tree

Understanding and Investigating Homogeneity Failures during Bulk Hold Homogeneity failures during bulk holds of liquid oral dosage forms like syrups and suspensions are critical issues that can compromise product quality…

Color Change On Stability during bulk hold: mixing, sampling, and hold-time controls

Addressing Color Change on Stability During Bulk Hold: A Practical Investigation Guide In the realm of pharmaceutical manufacturing, deviations such as unexpected color changes during stability testing can pose substantial…

Ph Drift after supplier change: packaging and transport risk assessment

Assessing pH Drift Risks Following Supplier Changes in Pharmaceutical Manufacturing In pharmaceutical manufacturing, changes to suppliers can introduce unforeseen variability, particularly when it comes to formulation components like pH-sensitive excipients…

Homogeneity Failure during scale-up: mixing, sampling, and hold-time controls

Understanding Homogeneity Issues During Scale-Up: Investigating Mixing, Sampling, and Hold-Time Controls Homogeneity failures in pharmaceutical manufacturing, particularly during the scale-up of liquid oral dosage forms, present significant challenges to quality…

Density Mismatch in oral suspension manufacturing: investigation flowchart aligned to GMP

Investigating Density Mismatch in Oral Suspension Manufacturing In the pharmaceutical manufacturing landscape, ensuring the correct density of oral suspensions is critical for product safety and efficacy. Density mismatch can lead…

Preservative Under-Dosing during filling line setup: manufacturing vs lab root cause decision tree

Analyzing Preservative Under-Dosing during Filling Line Setup: A Root Cause Investigation Approach In pharmaceutical manufacturing, the integrity of liquid oral dosage forms is paramount, especially in products requiring preservatives for…

Hold Time Bioburden Rise at accelerated stability: packaging and transport risk assessment

Investigating Hold Time Bioburden Elevations During Accelerated Stability Studies In the realm of pharmaceutical manufacturing, an unexpected rise in bioburden during hold time at accelerated stability conditions can pose significant…

Homogeneity Failure after supplier change: how QA should write CAPA for inspectors

Managing Homogeneity Failures Post-Supplier Change: A Guide for Quality Assurance In the realm of pharmaceutical manufacturing, ensuring product homogeneity is crucial for both compliance and therapeutic efficacy. A common issue…

Crystallization In Syrup after supplier change: water system and sanitation checks

Identifying and Addressing Crystallization in Syrups Following Supplier Changes In the pharmaceutical manufacturing landscape, the integrity of liquid oral dosage forms, such as syrups, is paramount. A recent challenge arises…

Preservative Under-Dosing during method transfer: manufacturing vs lab root cause decision tree

Understanding the Root Cause of Preservative Under-Dosing during Method Transfer in Pharmaceutical Manufacturing In pharmaceutical manufacturing, particularly within liquid oral dosage forms such as syrups and suspensions, the precision of…

Homogeneity Failure after supplier change: water system and sanitation checks

Dealing with Homogeneity Issues after Supplier Transition: An Investigation Framework In pharmaceutical manufacturing, supplier changes can introduce variability that may lead to significant product quality issues, including homogeneity failures. Such…