Quality Systems – Page 255

Ph Drift during bulk hold: cleaning validation and worst-case selection

Investigation of pH Drift during Bulk Hold: Cleaning Validation and Worst-Case Selection pH drift during bulk hold presents significant challenges for pharmaceutical manufacturers, particularly within the realm of topical and…

Dose Delivery Variability at accelerated stability: process parameter review and validation impact

Investigation of Dose Delivery Variability During Accelerated Stability Testing In the dynamic environment of pharmaceutical manufacturing, variability in dose delivery during accelerated stability testing can lead to significant quality concerns,…

E&L Failure after packaging change: sampling, filtration, and EM controls

In the highly regulated landscape of pharmaceutical manufacturing, a packaging change can inadvertently lead to Extractables and Leachables (E&L) failures in drug products. Such occurrences pose significant quality risks and…

Curling After Packaging during EU/UK market supply: root cause mapping across materials and process

Root Cause Mapping for Curling in Transdermal Drug Delivery Systems after Packaging The occurrence of curling in transdermal drug delivery systems after packaging can pose significant challenges for pharmaceutical manufacturers,…

Fill Weight Variability after packaging change: GMP investigation and CAPA strategy

Investigation of Fill Weight Variability Following a Packaging Change in Pharmaceutical Manufacturing In pharmaceutical manufacturing, consistency in fill weight is crucial for ensuring product quality and regulatory compliance. Recently, a…

Ivrt Failure during EU/UK market supply: process parameter review and validation impact

Investigating IVRT Failures Impacting EU/UK Market Supply: A Process Review In the pharmaceutical industry, ensuring the efficacy and safety of products is a paramount concern. Among various quality assurance measures,…

Fill Weight Variability during homogenization: GMP investigation and CAPA strategy

Investigating Fill Weight Variability during Homogenization: A GMP Approach In pharmaceutical manufacturing, maintaining consistency in product fill weights is crucial to meet the stringent requirements of regulatory agencies. Fill weight…

Ivpt Failure during EU/UK market supply: process parameter review and validation impact

Investigation of Ivpt Failure in EU/UK Market Supply: Reviewing Process Parameters and Validation Impact In pharmaceutical manufacturing, in vitro permeation testing (IVPT) is crucial for ensuring the efficacy and safety…

Pet Failure during sterile filtration: CAPA and effectiveness check plan

Addressing Pet Failures during Sterile Filtration: An Investigation Approach Pet failures during sterile filtration present significant challenges in pharmaceutical manufacturing, particularly in the production of ophthalmic dosage forms. The inability…

Phase Separation during bulk hold: mixing and sampling controls for QA review

Investigating Phase Separation During Bulk Hold: Essential Controls for Quality Assurance In the pharmaceutical manufacturing landscape, maintaining product integrity during storage is paramount. Phase separation during bulk hold can lead…

Coating Weight Variability after backing material change: root cause mapping across materials and process

Investigating Coating Weight Variability Following Backing Material Changes Coating weight variability is a common concern within pharmaceutical manufacturing, particularly following changes in backing materials. Fluctuations in coating weight can impact…

Color Change at accelerated stability: mixing and sampling controls for QA review

Identifying and Investigating Color Change During Accelerated Stability for Quality Assurance Color change during accelerated stability testing can present significant challenges in pharmaceutical manufacturing, particularly for topical and dermatological dosage…