Category: Healthcare Best Practices

How to Do Risk Assessment of IT Networks for FDA compliance

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With the complexity of today’s IT infrastructure and the applications running on networks there is always a risk that something goes wrong. Consequences can be a significant loss of revenue because of production stops, potential safety or health problems if inaccurate data transfer led to inaccurate reporting of laboratory results with consequent inadequate releases of Read more about How to Do Risk Assessment of IT Networks for FDA compliance[…]

Risk management of existing(Legacy) systems for FDA Compliance

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Risk management of existing systems is just as important as for new systems. The question is not: how old is the system? But rather: what is it being used for? You may also ask yourself what happens if something goes wrong and what is the likelihood that something does go wrong.  The main difference for Read more about Risk management of existing(Legacy) systems for FDA Compliance[…]

How to do risk assessment of Spreadsheet and Macros

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Spreadsheet calculations are popular in all kinds of businesses. Macro programs are used to add functionality to standard programs and to automated processes. Results generated by Macro and Spreadsheet (M&S) calculations are frequently used to make business decisions. M&S are also frequently used in regulated environments, for example batch releases in pharmaceutical manufacturing can be Read more about How to do risk assessment of Spreadsheet and Macros[…]

How to do Risk Management of Computer Systems Used for FDA Compliance

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Computers are used throughout pharmaceutical research, development, clinical trials and manufacturing. They are used to control equipment and acquire and evaluate data. Data generated by computer systems are used to make decisions whether or not to release drugs into the market and to release batches of finished products for shipment. Not being able to ship Read more about How to do Risk Management of Computer Systems Used for FDA Compliance[…]

How to create Risk Management Master Plan For FDA Regulated Companies

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The Risk Management Master Plan aims to ensure efficient and uniform execution of risk assessment and control procedures throughout the organization, aligning with regulatory standards, customer expectations, quality benchmarks, and business objectives. It also emphasizes the importance of comprehension and adherence to the company’s risk management protocols across all levels of the organization. This comprehensive Read more about How to create Risk Management Master Plan For FDA Regulated Companies[…]

Common issues related to data integrity

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Data integrity is “The maintenance of, and the assurance of the accuracy and consistency of, data over its entire life cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data integrity is the opposite of data corruption, which is a form of data Read more about Common issues related to data integrity[…]

FDA’s Dec 2018 Guidance on Data Integrity

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What is Data Integrity ? The definition of Data integrity is that a data need to be complete, consistent, and accurate . The concept applies to CGMP and Good Clinical Practice (ICH E6). Data should be “ALCOA” ( Attributable, Legible , Contemporaneous, Original or true copy, Accurate ) Key Concepts of Data Integrity: Metadata : Read more about FDA’s Dec 2018 Guidance on Data Integrity[…]

CGMP guidance for Phase I Investigational Drugs

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This guideline is intended to help in applying current good manufacturing practice (CGMP) required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in the manufacture of most investigational new drugs (IND) used in phase I clinical trials. This guidance describes an approach to •Implementation of manufacturing controls that are appropriate Read more about CGMP guidance for Phase I Investigational Drugs[…]

Basics of Japanese Medical Device GCP (JGCP)

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JPAL Laws, Ordinances and Notifications (relevant to GCP audits & the foreign manufacturer) The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005)MHLW Ministerial Ordinance No. 36 Clinical Tests for Medical Devices (hereinafter referred to as “Medical Device GCP” or “JGCP”)YAKUSHOKUKIHATSU No. 0720005 Read more about Basics of Japanese Medical Device GCP (JGCP)[…]

FDA inspection – Effective SOP for participants duty

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Following are key points need to be followed to have a successful FDA inspection. following people play major role in FDA inspections and hence the roles and responsibilities must be defined well and informed. -Receptionist Maintains a Current Inspection Contact List Actively in Contacting Key Personnel Trained on FDA Inspection SOP Does notReview – FDA Read more about FDA inspection – Effective SOP for participants duty[…]