FDA Guidelines

Top 10 Common Audit Findings in Pharmaceutical Manufacturing

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Common Audit Findings in Pharmaceutical Manufacturing

Below is a summary of the 10 most frequently observed audit findings in pharmaceutical manufacturing plants, followed by detailed descriptions, examples, preventive strategies, and relevant industry keywords. Each issue is based on industry reports and regulatory inspection data. Common Audit Finding: 1. Documentation and Record-Keeping Deficiencies: Deficiencies in documentation and records, such as missing or … Read more

FDA Form 483 | Warning Letters: How to Handle, Form, Example

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FDA Form 483 | Warning Letters

Understand and Differentiate them FDA Form 483 and Warning Letters: FDA Form 483 is like a detailed report card that talks about what people saw when they visited the manufacturing site. These people work for the FDA, and they write down everything they notice in a special order based on how important it is. Each … Read more

Handling of Laboratory Incident in Pharma

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laboratory incident

Laboratory Incident Definition: Any unintentional or unexpected event occurring during, discovered within, or arising after analysis that may adversely impact the quality of data and the resulting outcomes. Types of Common Laboratory Incidents: Below are the different common types of lab incidents in the pharmaceutical field that often occur. Type of Lab incident: Laboratory incidents … Read more

ALCOA to ALCOA Plus and Data integrity

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ALCOA to ALCOA plus

Data integrity is a key approach in the pharmaceutical quality control system. ALCOA stands for (Attributable, Legible, Contemporaneous, Original, and Accurate). It was introduced in the 1990s to ensure the framework for data integrity and good documentation practice (GDP). Then further introduced another term called ALCOA+. ALCO+ stands for (Complete, Consistent, Enduring, and Available) currently used by the … Read more