GMP Tips

Never Discard Rejected Materials in General Trash Bins

May 13, 2025 digi

Never Discard Rejected Materials in General Trash Bins Rejected Materials Must Not Be Thrown into General Waste Bins Remember: Discarding rejected materials in general trash is a serious GMP violation—use designated, controlled disposal procedures. Why This Matters in GMP Rejected pharmaceutical materials, whether due to contamination, deviation, or quality failure, must be handled with utmost…

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

Do Not Wear Jewelry or Cosmetics Inside Cleanroom Areas

May 12, 2025 digi

Do Not Wear Jewelry or Cosmetics Inside Cleanroom Areas Jewelry and Cosmetics Are Strictly Prohibited in Cleanrooms Remember: Personnel must not wear jewelry, makeup, or skin creams inside GMP cleanrooms due to contamination risk. Why This Matters in GMP Cleanrooms are designed to minimize contamination and maintain strict environmental controls. Wearing jewelry or cosmetics defeats…

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

Do Not Record Test Results Before Completing the Analysis

May 11, 2025 digi

Do Not Record Test Results Before Completing the Analysis Record Test Results Only After Full Completion of Analysis Remember: Entering test results before completing the entire analysis violates data integrity and can mislead quality decisions. Why This Matters in GMP Premature documentation of test results is a critical GMP violation. Such entries misrepresent the actual…

GMP Tips

Verify Reagent Expiry Dates Before Use in QC Laboratories

May 11, 2025 digi

Verify Reagent Expiry Dates Before Use in QC Laboratories Check Reagent Expiry Dates Before Use in QC Testing Remember: Never use reagents in QC labs without verifying their expiry dates — expired reagents compromise test accuracy and compliance. Why This Matters in GMP Reagents play a critical role in analytical testing and product release decisions….

GMP Tips

Never Skip Microbial Monitoring in Critical GMP Zones

May 10, 2025 digi

Never Skip Microbial Monitoring in Critical GMP Zones Never Skip Microbial Monitoring in Classified Areas Remember: Microbial monitoring in critical GMP areas must be consistent and documented — skipping it compromises product sterility and compliance. Why This Matters in GMP In sterile manufacturing, microbial monitoring is a frontline defense against contamination. Skipping or reducing sampling…

GMP Tips

Maintain Access Logs for Electronic GMP Systems to Ensure Accountability

May 10, 2025 digi

Maintain Access Logs for Electronic GMP Systems to Ensure Accountability Keep Detailed Access Logs for Electronic GMP Systems Remember: Every login, action, or change in GMP electronic systems must be logged and traceable to ensure accountability. Why This Matters in GMP Electronic systems are integral to data collection, analysis, and product release decisions in pharmaceutical…

GMP Tips

Avoid Manual Data Corrections Without Proper Justification

May 9, 2025 digi

Avoid Manual Data Corrections Without Proper Justification Never Perform Manual Data Corrections Without Justification Remember: All corrections to GMP data must be explained, signed, dated, and reviewed — never make undocumented changes. Why This Matters in GMP In regulated environments, every data entry is subject to traceability and verification. Manual corrections without justification raise serious…

GMP Tips

Requalify HVAC Systems on Schedule to Maintain Environmental Control

May 9, 2025 digi

Requalify HVAC Systems on Schedule to Maintain Environmental Control Perform Scheduled Requalification of HVAC Systems in GMP Areas Remember: HVAC systems in cleanrooms must be requalified periodically to maintain airflow, pressure differentials, and contamination control. Why This Matters in GMP HVAC systems play a pivotal role in maintaining the cleanliness, temperature, humidity, and pressure gradients…

GMP Tips