Tag: manufacturing controls

Follow Hold Time Studies to Ensure Product Stability and Safety

May 14, 2025 digi

Follow Hold Time Studies to Ensure Product Stability and Safety Always Follow Hold Time Studies to Preserve Product Stability Remember: In-process materials must not exceed validated hold times—doing so risks microbial growth and product degradation. Why This Matters in GMP Hold time studies define how long a product or intermediate can be held between manufacturing…

GMP Tips

Avoid Operating Equipment Without Completing Logbook Entries

May 2, 2025 digi

Avoid Operating Equipment Without Completing Logbook Entries Never Use Equipment Without Properly Completing Its Logbook Remember: Equipment must not be operated unless logbook entries for prior and current usage are accurately recorded. Why This Matters in GMP In GMP-compliant environments, every piece of equipment has its own identity and operational history. Equipment logbooks serve as…

GMP Tips

Conduct Risk Assessments Before Implementing Process Changes

May 1, 2025 digi

Conduct Risk Assessments Before Implementing Process Changes Ensure Risk Assessment Precedes Any Change in Manufacturing Process Remember: Never initiate process changes without first conducting a documented risk assessment. Why This Matters in GMP In the pharmaceutical industry, even minor changes to a manufacturing process can have significant consequences. A change that appears harmless may introduce…

GMP Tips

Conduct Risk Assessments Before Implementing Process Changes

May 1, 2025 digi

GMP Tips