Tag: EU GMP

Do Not Ignore Elevated Noise Levels in GMP Classified Areas

May 22, 2025 digi

Do Not Ignore Elevated Noise Levels in GMP Classified Areas Monitor and Control Noise Levels in GMP Classified Zones Remember: High noise levels can impact operator focus, equipment monitoring, and cleanroom discipline—never ignore them. Why This Matters in GMP In GMP-classified areas, especially cleanrooms and sterile zones, ambient conditions must support operator performance, equipment efficiency,…

GMP Tips

Verify Integrity of Tamper-Evident Seals During Packaging

May 16, 2025 digi

Verify Integrity of Tamper-Evident Seals During Packaging Check Tamper-Evident Seals for Integrity During Packaging Remember: Tamper-evident seals must be visually verified during packaging to ensure they are applied correctly and uncompromised. Why This Matters in GMP Tamper-evident packaging is a vital mechanism for protecting pharmaceutical products against manipulation and counterfeiting. These seals serve as visible…

GMP Tips

Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination

May 15, 2025 digi

Prohibit Forklift Use in Primary Packaging Areas to Prevent Contamination Forklifts Must Not Be Operated in Primary Packaging Zones Remember: Forklift usage in clean or primary packaging areas violates GMP zoning and increases contamination and safety risks. Why This Matters in GMP Forklifts are designed for warehouse and bulk material movement—not for cleanroom or primary…

GMP Tips

Maintain Temperature Logs for Cold Chain Pharmaceutical Products

May 13, 2025 digi

Maintain Temperature Logs for Cold Chain Pharmaceutical Products Temperature Logs Are Mandatory for Cold Chain Product Storage Remember: Maintain real-time, accurate temperature records to protect cold chain product integrity and comply with GMP regulations. Why This Matters in GMP Cold chain pharmaceutical products such as vaccines, biologics, and temperature-sensitive APIs require strict storage conditions to…

GMP Tips

Calibrate Laboratory Balances Regularly Using Certified Weights

May 12, 2025 digi

Calibrate Laboratory Balances Regularly Using Certified Weights Always Calibrate Laboratory Balances with Certified Weights Remember: All lab balances must be calibrated using certified weights to ensure measurement accuracy and GMP compliance. Why This Matters in GMP Balances are among the most critical instruments in a pharmaceutical laboratory. They are used for weighing reference standards, samples,…

GMP Tips

Never Approve Batches Without Complete Analytical Test Reports

May 5, 2025 digi

Never Approve Batches Without Complete Analytical Test Reports Do Not Approve Any Batch Without Full Analytical Reports Remember: Ensure all required analytical test reports are reviewed and approved before batch release. Why This Matters in GMP Approving a batch without all relevant analytical reports compromises product quality assurance and puts patients at risk. Every batch…

GMP Tips

Label In-Process Samples with Date and Initials for Traceability

May 5, 2025 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…

GMP Tips

Verify Batch Yield Calculations Before Finalizing Manufacturing Records

May 3, 2025 digi

Verify Batch Yield Calculations Before Finalizing Manufacturing Records Always Verify Batch Yield Calculations Before BMR Finalization Remember: Confirm all yield values before signing off on the Batch Manufacturing Record (BMR). Why This Matters in GMP Yield reconciliation is a critical component of GMP manufacturing that ensures raw materials are efficiently converted into finished products. Yield…

GMP Tips

Health Products Regulatory Authority – HPRA

April 13, 2024 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…

GMP Guidelines

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

April 13, 2024 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;…

GMP Blog