manufacturing controls – Pharma GMP

Maintain Clear Segregation Between Different Product Families in GMP

digi — Mon, 02 Jun 2025 13:53:45 +0000

Maintain Clear Segregation Between Different Product Families in GMP Ensure Proper Segregation of Different Product Families in GMP Facilities Remember: Different product families must be physically and procedurally segregated during manufacturing and storage to prevent mix-ups and cross-contamination. Why This Matters in GMP Pharmaceutical facilities often produce multiple product types, such as tablets, injectables, or...

Follow Hold Time Studies to Ensure Product Stability and Safety

digi — Wed, 14 May 2025 04:19:46 +0000

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...

Avoid Operating Equipment Without Completing Logbook Entries

digi — Fri, 02 May 2025 12:29:43 +0000

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...

Conduct Risk Assessments Before Implementing Process Changes

digi — Thu, 01 May 2025 23:15:52 +0000

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...

Conduct Risk Assessments Before Implementing Process Changes

digi — Thu, 01 May 2025 10:09:00 +0000