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Tag: WHO GMP

Conduct Periodic Pest Control Audits in GMP Storage Areas

Posted on May 6, 2025 By digi

Conduct Periodic Pest Control Audits in GMP Storage Areas Schedule Regular Pest Control Audits in GMP Warehouses Remember: Routine pest control audits are crucial to preventing contamination and ensuring compliance in pharmaceutical storage areas. Why This Matters in GMP Pests pose a significant risk to pharmaceutical products. Rodents, insects, and birds can damage packaging, introduce…

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GMP Tips

Clean Sampling Tools After Each Use to Prevent Cross-Contamination

Posted on May 6, 2025 By digi

Clean Sampling Tools After Each Use to Prevent Cross-Contamination Always Clean Sampling Tools After Every Use Remember: Clean and sanitize all sampling tools after each use to avoid cross-contamination and maintain product integrity. Why This Matters in GMP Sampling tools come into direct contact with raw materials, APIs, and intermediate products. If not properly cleaned…

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GMP Tips

Label In-Process Samples with Date and Initials for Traceability

Posted on May 5, 2025 By digi

Label In-Process Samples with Date and Initials for Traceability Always Label In-Process Samples with Date and Initials Remember: In-process samples must be clearly labeled with the sampling date and initials of the person who collected them. Why This Matters in GMP In-process samples provide real-time insight into product quality at different stages of manufacturing. Without…

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GMP Tips

Health Products Regulatory Authority – HPRA

Posted on April 13, 2024 By digi

  Exploring the Health Products Regulatory Authority (HPRA) – Ireland Introduction Welcome to a detailed exploration of the Health Products Regulatory Authority (HPRA) in Ireland. As Ireland’s national regulatory agency for medicines, medical devices, and healthcare products, the HPRA plays a critical role in protecting public health and ensuring the quality and safety of healthcare…

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GMP Guidelines

Explain the role of GMP in preventing contamination and cross-contamination

Posted on April 13, 2024 By digi

Role of GMP in Preventing Contamination and Cross-Contamination Good Manufacturing Practice (GMP) plays in safeguarding product quality and patient safety. GMP is the cornerstone of our industry, setting the standard for the meticulous processes and protocols that ensure contamination and cross-contamination are effectively minimized. The Essence of GMP GMP isn’t just a set of guidelines;…

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GMP Blog

Explain the role of GMP in preventing contamination and cross-contamination.

Posted on April 13, 2024 By digi

Role of GMP in Preventing Contamination and Cross-Contamination in Pharmaceutical Manufacturing Good Manufacturing Practice (GMP) plays a crucial role in preventing contamination and cross-contamination in pharmaceutical manufacturing. Contamination refers to the unintended presence of harmful substances or impurities, while cross-contamination refers to the transfer of contaminants between different materials, equipment, or products. GMP guidelines provide…

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GMP Blog

GMP Guidelines to Ensure Product Quality and Safety

Posted on April 13, 2024 By digi

How GMP Guidelines Ensure Product Quality and Safety in Pharmaceutical Manufacturing Good Manufacturing Practice (GMP) guidelines play a critical role in ensuring the quality and safety of pharmaceutical products throughout their manufacturing process. These guidelines are designed to establish a standardized approach that pharmaceutical companies must follow to maintain the highest level of quality and…

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GMP Blog

Principles of GMP

Posted on April 13, 2024 By digi

Key Principles of Good Manufacturing Practice (GMP) in Pharmaceutical Manufacturing In pharmaceutical manufacturing, adhering to Good Manufacturing Practice (GMP) is crucial to ensure the quality, safety, and efficacy of medicinal products. GMP provides a set of guidelines and standards that pharmaceutical companies must follow during the manufacturing process. Here are the key principles of GMP:…

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GMP Blog

Pharmaceuticals – Process Validation

Posted on March 13, 2024 By digi

  Process Validation in Pharmaceuticals Process validation is a critical aspect of pharmaceutical manufacturing, ensuring that production processes consistently produce products that meet quality standards and regulatory requirements. In this article, we’ll delve into the importance of process validation in pharmaceuticals and outline the procedure for conducting process validation. Importance of Process Validation Process validation…

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Validation and Qualification Processes in GMP

About Validation

Posted on March 12, 2024March 13, 2024 By digi

Validation in Pharmaceuticals Validation is a critical process in the pharmaceutical industry, ensuring that products meet quality standards and regulatory requirements. It involves systematic evaluation and documentation of processes, equipment, and systems to demonstrate their suitability for intended use. In this article, we’ll explore the various components of validation in the context of pharmaceuticals. Components…

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Validation and Qualification Processes in GMP

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  • Never Obstruct Sensors or Alarms with Materials in GMP Areas

    Never Obstruct Sensors or Alarms… Read more

WHO GMP

  • Never Obstruct Sensors or Alarms with Materials in GMP Areas
  • Qualify HVAC Systems in Warehouses to Maintain GMP Storage Conditions
  • Never Handle Rejected Goods During Active GMP Production
  • Ensure QA Oversight in Destruction of GMP Rejected Products
  • Never Use Fiber-Shedding Materials for Machine Cleaning in GMP Areas
  • Review Environmental Monitoring Data Trends to Ensure GMP Compliance
  • Avoid Water Stagnation in GMP Drains and Sinks to Prevent Contamination
  • Test Compressed Air for Microbial Contamination in GMP Utilities
  • Always Perform Swab Sampling After Cleaning Validation
  • Verify Integrity of Double-Door Pass Boxes to Prevent Cross Contamination

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