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GxP Assessment & Categorization of Computerized System

In Earlier post we understand what steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed. Now in this article we are going to understand GxP Assessment & Categorization of Computerized System. It is first stage of whether a system requires a validation isContinue reading “GxP Assessment & Categorization of Computerized System”

Steps should be executed for performing Computer System Validation

In Earlier post we understand what is Computer System Validation (CSV), Why CSV Required, Purpose of CSV & Benefits of CSV. Now in this article we are going to understand steps which should be executed during computer system Validation activity. These steps will helpful to understand how CSV will be performed. Each & every stepsContinue reading “Steps should be executed for performing Computer System Validation”

What is CSV, Its Need, Purpose & Benefits in pharma Industry.

History of CSV: The concept of validation was derived from engineering principles of validation of mechanical system that has been extended to the software industry. To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug Administration (FDA) officials first proposed the concept of validation in order to improve theContinue reading “What is CSV, Its Need, Purpose & Benefits in pharma Industry.”

What is Whistle-blowing? It will save you or your Company or Public?

Whistle-blowing: The pharmaceutical industry is huge, Worldwide and more closer to home. India is also one of the largest exporters of medicines to the United States. Medicines are highly regulated for expected reasons. Over the last few years, corporate India has seen the rise of a new kind of crusader – the whistle-blower. These championsContinue reading “What is Whistle-blowing? It will save you or your Company or Public?”

Understanding basic difference between Form 483 & Warning Letters

The Form 483 & FDA Warning Letter both serves a similar purpose to inform sponsors & principal investigators of issues requiring corrective action. An FDA 483 observation is a notice that highlights potential regulatory problems, while a warning letter is an escalation of this notice. You need to respond in writing within 15 days ofContinue reading “Understanding basic difference between Form 483 & Warning Letters”

Do’s and Don’ts During FDA Inspection

Do’s: • Answer all questions honestly; • Say “I don’t know” or “I’ll get the answer for you;” • Avoid such phrases as “I think,” “Sometimes/often/usually,” “never” and “next time;” • Avoid qualifiers, such as “typically,” “normally,” “generally” and “usually;” • Stop speaking once the question is answered; • Ask for explanations or interpretations ofContinue reading “Do’s and Don’ts During FDA Inspection”

You must know Inspection Techniques that followed by your next Inspectors

What is QSIT? QSIT provides guidance to the FDA field staff on the inspection process used to assess medical device manufacturer’s compliance with quality system regulations. An FDA quality system inspection technique audit focuses primarily on four major subsystems and their respective documentation samples and is an efficient way to determine systemic weaknesses. When anContinue reading “You must know Inspection Techniques that followed by your next Inspectors”

What FDA will Expect from your Next Inspection?

In Earlier post we understood What is Agenda for your Next Inspection in Pharma Industry? Now in this article we are going to understand What FDA will expect from your Next Inspection. FDA conducts Inspections to Assess compliance with applicable Laws and Regulations Investigators to conduct inspections in a Reasonable manner Industry to welcome the investigator professionally andContinue reading “What FDA will Expect from your Next Inspection?”

Agenda for your Next Inspection

In Earlier post we understood What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry? Now in this article we are going to understand What is Agenda for your Next Inspection in Pharma Industry? Inspection Agenda: Looking at some crucial points that ensure data integrity, it quickly becomes clear that this is notContinue reading “Agenda for your Next Inspection”

What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry?

In Earlier post we understood Preparation of Successful Inspections & Preparation tips which useful in during your next inspection. Now in this article we are going to understand What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry? Mock Inspection: Mock FDA inspection is an essential tool in identifying issues that couldContinue reading “What is Mock Inspection & Is it Really helpful in Actual Inspection in Pharma Industry?”