CHANGE CONTROL REPORT REPLACEMENT OF RAPID MIXER GRANULATOR (RMG)
CHANGE CONTROL REPORT
1. SECTION-I : REQUEST FOR CHANGE
Change Control Number
CC/PROD/2026/RMG/001
Initiating…
Browsing Tag
PHARMAGUIDELINE
337 posts
CHANGE CONTROL REPORT FOR INSTALLATION OF NEW FLUID BED DRYER (FBD)
CHANGE CONTROL REPORT
AABBCC PHARMACEUTICALS
QUALITY ASSURANCE DEPARTMENT
INSTALLATION OF NEW FLUID BED DRYER…
AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
AUDIT COMPLIANCE REPORT FOR SOPs NOT REVISED PERIODICALLY
1. Context of Observation
During the WHO GMP…
AUDIT COMPLIANCE REPORT INCORRECT SIEVE SIZE USED DURING MILLING
CONTEXT OF OBSERVATION
Product Details
• Product Name: XXXXX Tablets
• Batch Number: XXXXX
• Batch Size: XXXXX…
SOP FOR RAW MATERIAL EXPIRY CONTROL AND FEFO MANAGEMENT SYSTEM
1. Receiving Raw Materials
Inspection at Receipt: Upon arrival, trained personnel must inspect and document each…
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
AUDIT COMPLIANCE REPORT FOR MISSING RAW MATERIAL IDENTIFICATION LABELS
1. Context of Observation
During the WHO…
AUDIT COMPLIANCE REPORT FOR CROSS-CONTAMINATION DURING DISPENSING
AUDIT COMPLIANCE REPORT FOR CROSS-CONTAMINATION DURING DISPENSING
1. Context of Observation
During the WHO GMP…
AUDIT COMPLIANCE REPORT FOR FAILURE TO FOLLOW APPROVED BATCH MANUFACTURING RECORD (BMR)
AUDIT COMPLIANCE REPORT FOR FAILURE TO FOLLOW APPROVED BATCH MANUFACTURING RECORD (BMR)
1. Context of…
AUDIT COMPLIANCE REPORT FOR INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
AUDIT COMPLIANCE REPORT FOR INADEQUATE LINE CLEARANCE BEFORE BATCH START IN GRANULATION AREA
1. Context of…
AUDIT COMPLIANCE REPORT FOR LACK OF MANAGEMENT REVIEW OF QUALITY MANAGEMENT SYSTEM (QMS)
Response to WHO GMP Observation
Observation
Observation: Lack of Management Review of Quality Management System…