Dosage Forms & Drug Delivery Systems – Page 23

Coating Weight Variability after adhesive change: GMP investigation plan and CAPA

The first step in tackling coating weight variability is to recognize the symptoms signaling a potential issue. Common signals that may indicate a problem include:Click to read the full article.

Fill Weight Variability in cream manufacturing: mixing and sampling controls for QA review

The first step in addressing fill weight variability is recognizing the symptoms that indicate a problem exists. Common signs include:Click to read the full article.

Ivrt Failure during die-cutting: GMP investigation plan and CAPA

Identifying symptoms of IVRT failure during die-cutting is the crucial first step in any investigative process. Common signs that signal an issue may include:Click to read the full article.

E&L Failure at stability pull: sampling, filtration, and EM controls

Investigating E&L Failures During Stability Pulls: A Practical Guide In pharmaceutical manufacturing, especially when dealing with ophthalmic dosage forms, extracting the appropriate product for stability pulls is crucial to ensure…

E&L Failure during lamination: GMP investigation plan and CAPA

Identifying E&L failures begins with recognizing symptoms in the manufacturing environment. E&L failures may manifest through various signals, which can be classified into atypical results from analytical tests, physical abnormalities,…

Phase Separation in ointment filling: complaint trending and risk-based actions

In a pharmaceutical manufacturing environment, recognizing the early signs of phase separation during ointment filling is crucial. Symptoms typically include:Click to read the full article.

Packaging Dry-Out after adhesive change: process parameter review and validation impact

The first step in investigating packaging dry-out following an adhesive change is recognizing the observable symptoms. Manufacturing, quality control, and quality assurance professionals should be vigilant for the following signals:Click…

Cleaning Validation Failure during bulk hold: how to document deviations for FDA/EMA

Identifying symptoms or signals of a cleaning validation failure is the first step in an effective investigation. Symptoms may manifest as:Click to read the full article.

Pet Failure during method transfer: FDA-ready investigation report and batch disposition

Understanding the symptoms observed during the incident is paramount. In recent occurrences of pet failure, the following were noted:Click to read the full article.

E&L Failure during lamination: inspection-ready documentation pack

Before commencing an investigation, it is essential to recognize the symptoms indicative of E&L failures during lamination. These can manifest in various forms, including:Click to read the full article.

Assay Oos in cream manufacturing: GMP investigation and CAPA strategy

Identifying symptoms or signals of an assay OOS is critical for timely intervention. Common indicators might include:Click to read the full article.

Drug Crystallization during EU/UK market supply: process parameter review and validation impact

Recognizing early symptoms of drug crystallization can significantly mitigate risks associated with batch quality. Key signals include:Click to read the full article.