Raw Materials & Excipients Management – Page 11

Moisture sensitivity overlooked during supplier qualification – regulatory scrutiny of excipient data

Symptoms related to moisture sensitivity can manifest in various ways during the manufacturing and testing stages. Identifying these early signals is crucial for prompt action. Common indicators include:Click to read…

Supplier grade substitution during formulation development – preventing late-stage reformulation

Addressing Supplier Grade Substitution During Formulation Development to Prevent Late-Stage Reformulation The pharmaceutical sector continually faces challenges related to material quality, particularly concerning supplier grade substitutions during formulation development. Such…

Supplier grade substitution during regulatory review – CAPA for formulation failures

The first step in managing supplier grade substitution issues is recognizing the symptoms that may indicate a problem. These signals can originate from various areas, including production floors and lab…

Unjustified excipient choice during supplier qualification – compatibility study expectations

Understanding the symptoms or signals that indicate an issue with excipient selection is critical in the investigation lifecycle. Staff in manufacturing and quality control should be trained to recognize these…

Functional performance failure during scale-up – regulatory scrutiny of excipient data

Functional performance failures can manifest in various ways during scale-up. Some of the most common symptoms to be vigilant for include but are not limited to:Click to read the full…

Functional performance failure during scale-up – preventing late-stage reformulation

Addressing Functional Performance Failures During Scale-Up: An Investigation Guide In the fast-paced world of pharmaceutical manufacturing, functional performance failures during scale-up can pose significant risks, particularly when they necessitate late-stage…

Unjustified excipient choice during formulation development – risk assessment for excipient choice

Identifying the initial signs of problems related to unjustified excipient choices is critical for early intervention. Common symptoms might include:Click to read the full article.

Functional performance failure during supplier qualification – risk assessment for excipient choice

Functional performance failures can manifest through various symptoms during testing, manufacturing, or during the review of batch records. Identifying these signals promptly is essential for initiating a thorough investigation.Click to…

Unjustified excipient choice during supplier qualification – CAPA for formulation failures

The initial signals of a potential formulation failure related to unjustified excipient choice could manifest during various stages of the manufacturing process. Some common symptoms include:Click to read the full…

Supplier grade substitution during formulation development – compatibility study expectations

When supplier grade substitutions occur, various symptoms may manifest, signaling an underlying issue during formulation development. Recognizing these signals early can prevent more significant compliance-related problems down the line. Key…

Moisture sensitivity overlooked during regulatory review – compatibility study expectations

Recognizing early symptoms of moisture sensitivity issues is critical for timely interventions. Symptoms can manifest in various forms, and being vigilant can prevent larger scale complications. Some of the key…

Variability in excipient grade during supplier qualification – compatibility study expectations

Symptoms or signals indicating variability in excipient grade may manifest during various stages of manufacturing, compounding, or analytical testing. Such signals include:Click to read the full article.