In Earlier post we understood Types of Inspection carried out in Pharma Industry. Now in this article we are going to understand Preparation of Successful Inspections & Preparation tips which useful in during your next inspection. Being inspection ready means that pharmaceutical leaders are committed to managing compliance as part of their company culture. Will you know when FDAContinue reading “Preparing for Successful Inspections is not a one-time Task”
Author Archives: Innovative Appz
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?”
Types of Inspections in Pharma Industry
In Earlier post we understood Overview of Inspection, Purpose, How to Inspection Team, what are the Inspection Steps & Inspection Strategy, Now in this article we are going to understand Types of Inspection carried out in pharma industry. Types of Inspection: The four different types of inspections conducted by FDA are pre-approval inspection, routine inspection,Continue reading “Types of Inspections in Pharma Industry”
Overview of Pharma Inspection from Ground Level
What is Inspection? All Records required under CGMP are subject to FDA inspection. This applies to records generated & maintained on computerized systems, including electronic communications that support CGMP activities. For example, an email to authorize batch release is a CGMP record that FDA may review. You must allow authorized inspection, review, and copying ofContinue reading “Overview of Pharma Inspection from Ground Level”
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”
Is Qualification is necessary & when Re-Qualification performed?
Qualification is defined as an action of providing that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances. Need of Qualification To manufactured a quality product ProofContinue reading “Is Qualification is necessary & when Re-Qualification performed?”
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