Pharmaceutical Guidance Complete Pharma Solution
USFDA 483 Warning Letter Dated MARCH 30, 2022 This warning letter summarizes significant violations of …
Read More »Quality Metrics in pharmaceutical industry
Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor …
Read More »REMEDIATION OF DATA INTEGRITY FAILURES
Classification of data integrity deficiencies
Out of Specification & Out of Trend Investigations as per MHRA
TOOLS FOR QUALITY IMPROVEMENT PART – I
Human Errors
What are the different types of Quality Management systems (QMS)?
What is future mapping?
OUT OF SPECIFICATIONS (OOS)
Microbiological Efficacy of the Cycle
Microbiological Efficacy of the Cycle Validation studies that demonstrate the efficacy (lethality) of the production …
Read More »Microbiological Monitoring of the Environment
Operation, cleaning and maintenance of Static Pass Box.
STERILITY ASSURANCE
Functioning, cleaning and maintenance of Dynamic Pass Box
Quality Metrics in pharmaceutical industry
Quality Metrics in pharmaceutical industry Quality metrics are used throughout the pharmaceutical industry to monitor …
Read More »Bung Processor / Autoclave
VIAL WASHING MACHINE
Sterilization and depyrogenation tunnel
ASEPTIC PROCESSES VALIDATION AS PER PIC/S
Reference-Standard and Working Standards
Reference-Standard and Working Standards The US Food and Drug Administration defines a reference-standard material as …
Read More »HPLC Interview Questions
SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA
Quality Risk Management in Analytical Laboratory
IMPURITIES IN NEW DRUG SUBSTANCES