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?”
Category Archives: Data Integrity
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 happens if you not done Software Validation
Software validation is part of computerized system validation (CSV). Computerized system validation defined as a documented evidence with a high degree of assurance that the software/computerized system, functions as per software design and user requirements in a consistent and reproducible manner. Software Validation by Functionality Electronic Record & Signatures Recall/hold functionality Serialization/lot control —Continue reading “What happens if you not done Software Validation”
What is Requirements Traceability Matrix (RTM) & What regulatory say about RTM?
What is Traceability Matrix? (TM) A TM is a document that co-relates any two-baseline documents that require a many-to-many relationship to check the completeness of the relationship. It is used to track the requirements and to check the current project requirements are met. What is RTM? RTM is a method used to establish the relationshipContinue reading “What is Requirements Traceability Matrix (RTM) & What regulatory say about RTM?”
Activities followed during Retirement & Decommissioning of instrument/equipment in pharma industry.
The retirement and decommissioning process is the last stage in application or product life cycle management. Many different factors can trigger this event such as technological advancement, business needs & acquisitions/mergers while the underlying business process can become obsolete, etc. In regulated life science companies, the retirement & decommissioning process should be planned & documented.Continue reading “Activities followed during Retirement & Decommissioning of instrument/equipment in pharma industry.”
One steps ahead from Paper base Logbook to E Logbook Management
Log management is one of the most essential elements of Quality management system. Documenting, maintaining equipment usage & cleaning log with audit trail is mandatory requirement as per regulatory. Proper log management of the equipment in the organization is necessary to ensure accurate, reliable, and timely manufacturing details of products Paper-based equipment use logs comeContinue reading “One steps ahead from Paper base Logbook to E Logbook Management”
Is your instrument is calibrated? Factors which decide calibration frequency?
Calibration is a process that demonstrates a particular instrument or device produces results within specified limits, as compared to those produced by a traceable standard over an appropriate range of measurements. Calibration activities must be performed with qualified instruments by an accredited laboratory. In calibration set of operations are performed under specified conditions & produces instrumentContinue reading “Is your instrument is calibrated? Factors which decide calibration frequency?”
Factors which never missed in Periodic System Review
Periodic System Review /Evaluation Conducting periodic reviews on GxP systems, assets and/or processes that have already been validated is a critical aspect in any validated environment. It is important to review a system or process for changes both physical and procedural in order to verify that a system or process is operating as expected. ForContinue reading “Factors which never missed in Periodic System Review”
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