ICH – Page 136 – Pharma.Tips

Microbial Limits Failure in syrup production: mixing, sampling, and hold-time controls

Addressing Microbial Limits Failures in Syrup Production: A Comprehensive Investigation Approach Microbial limits failures can present significant challenges in the production of liquid oral dosage forms such as syrups. Such…

Foaming And Air Entrapment during bulk hold: packaging and transport risk assessment

Investigating Foaming and Air Entrapment during Bulk Hold: A Risk Assessment for Packaging and Transport In pharmaceutical manufacturing, the integrity and quality of liquid oral dosage forms are paramount. One…

Color Change On Stability during EU/UK market supply: investigation flowchart aligned to GMP

Investigation Flowchart for Color Change on Stability during EU/UK Market Supply Color change in liquid oral dosage forms such as syrups and suspensions during stability studies can indicate underlying issues…

Fill Volume Variability after supplier change: mixing, sampling, and hold-time controls

Addressing Fill Volume Variability Following a Supplier Change: Effective Strategies for Control and Compliance In the realm of pharmaceutical manufacturing, particularly when dealing with liquid oral dosage forms, maintaining consistent…

Viscosity Drift during filling line setup: how QA should write CAPA for inspectors

Addressing Viscosity Drift in Filling Line Setup: A Comprehensive Approach for Quality Assurance Viscosity drift during the filling line setup can significantly impact the quality and safety of liquid oral…

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…