Pharmaceutical Packaging Systems – Page 23

Temperature Logger Placement in Cold Chain Shipments

Temperature excursions can manifest in various ways during cold chain operations. Below are common symptoms and signals that indicate a potential failure in maintaining required temperature ranges:Click to read the…

E&L Data Integrity: Raw Data, Unknowns, and Toxicology Traceability

Symptoms indicating potential E&L-related issues may vary from unusual lab results to customer complaints. Common symptoms include:Click to read the full article.

Cold Chain Packaging CAPA After Temperature Excursions

In the realm of cold chain logistics, early detection of temperature excursions can prevent loss of product quality and ensure compliance with regulatory standards. Symptoms that indicate a potential failure…

How to Investigate Patient Complaints Linked to Taste or Odor Leachables

Identifying the symptoms or signals related to taste or odor complaints is the first step in addressing the issue. Here are common observations that may indicate a problem with E&L:Click…

How to Define Acceptance Criteria for Thermal Shipper Qualification

Defining Acceptance Criteria for Qualification of Thermal Shippers in Cold Chain Systems In the pharmaceutical industry, the integrity of cold chain packaging systems is crucial to maintaining the quality of…

Extractables and Leachables for Veterinary and Nutraceutical Products

Identifying symptoms related to extractables and leachables issues is crucial for initiating an appropriate response plan.Click to read the full article.

Cold Chain Packaging for Last-Mile Pharmaceutical Distribution

Recognizing the symptoms of a compromised cold chain is the first step in effective temperature excursion management. The following indicators can signal a potential issue:Click to read the full article.

How to Handle E&L Deviations During Stability Studies

The first step in managing E&L deviations is to be vigilant for symptoms or signals that indicate potential issues. These may manifest as unexpected compound levels in stability samples, alterations…

Reuse and Requalification of Cold Chain Shipping Containers

Professionals in pharmaceutical manufacturing and quality should remain vigilant for specific signals that could indicate issues with cold chain packaging systems. Symptoms may include:Click to read the full article.

Risk-Based E&L Strategy for US, EU, and UK Regulatory Expectations

In this case study, a routine quality control check revealed elevated levels of leachables in a batch of injectable solution, significantly above acceptable limits. Initial tests indicated a higher count…

Cold Chain Packaging Documentation for Regulatory Inspections

Identifying symptoms or signals is the first step in managing potential issues with cold chain packaging systems. Look for the following indicators:Click to read the full article.

How to Qualify Alternative Packaging Materials Using E&L Data

The need for E&L studies often arises from specific signals observed during product development, batch release, or routine quality assurance checks. Symptoms that indicate potential problems include:Click to read the…