Dosage Forms & Drug Delivery Systems – Page 39

Microbial Limits Failure in dental gel manufacturing: packaging compatibility and shelf-life justification

Microbial limits failures often manifest through various signals in both laboratory testing and production environments. These may include:Click to read the full article.

Hold Time Bioburden Rise after supplier change: investigation steps with CAPA evidence

Investigating Hold Time Bioburden Increase Following a Supplier Change: Effective Steps for CAPA In the fast-paced world of pharmaceutical manufacturing, changes in suppliers can lead to unforeseen challenges, including Quality…

Texture Grittiness Complaint after supplier change: QMS trending and complaint handling expectations

The first step in addressing complaints related to texture grittiness involves identifying and documenting the symptoms observed either on the manufacturing floor or within laboratory analysis. Common symptoms may include:Click…

Microbial Limits Failure during method transfer: QMS trending and complaint handling expectations

Recognizing the symptoms of microbial limits failure is critical for initiating an effective response. Observations may include:Click to read the full article.

Assay Oos after supplier change: GMP documentation for FDA/EMA/MHRA review

Recognizing symptoms early in both manufacturing and laboratory settings is vital in addressing OOS results. Some common signals include:Click to read the full article.

E&L Failure after supplier change: sampling and mixing controls for QA review

Identifying the initial symptoms of an E&L failure is essential to initiate timely investigations. Common signals that may arise include:Click to read the full article.

Tube Leakage Complaint during method transfer: packaging compatibility and shelf-life justification

Identifying the symptoms or signals associated with tube leakage is critical for prompt investigation. Common signals may include:Click to read the full article.

Texture Grittiness Complaint after packaging change: sampling and mixing controls for QA review

The first step in any investigation is to clearly define the symptoms associated with the texture grittiness complaint. Often, these may be reported by end-users, quality control (QC) laboratories, or…

Viscosity Drift during inspection readiness: GMP documentation for FDA/EMA/MHRA review

Identifying symptoms associated with viscosity drift is the first step in an effective investigation. Symptoms can manifest during various processes, from formulation through to quality control testing. Typical signals include:Click…

Phase Separation during method transfer: sampling and mixing controls for QA review

The first step in identifying issues related to phase separation during method transfer is recognizing the signals present on the manufacturing floor or in the laboratory environment. Symptoms may manifest…

Ph Drift after packaging change: packaging compatibility and shelf-life justification

Recognizing symptoms of pH drift is crucial for initiating an effective investigation. Common indicators include:Click to read the full article.

Assay Oos in ear drop manufacturing: manufacturing vs lab root cause decision tree

In any manufacturing setting, the detection of an OOS result is typically the first clear signal that something has deviated from the expected performance standards. In ear drop manufacturing, possible…