Category: Pharma 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[…]

How to Organize the Quality Agreement for Drug Products Manufacturing

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A quality agreement is a crucial document that defines the responsibilities and expectations of the parties involved in the manufacturing of pharmaceutical products. The quality agreement helps in ensuring that the product is produced in compliance with the regulatory requirements and also meets the quality standards. One of the essential aspects of the quality agreement is Read more about How to Organize the Quality Agreement for Drug Products Manufacturing[…]

ICH Q9 – Quality Risk Management

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The purpose of Q9 is to serve as a foundational or resource document that is independent yet supports other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines. Different from other ICH guidelines and Provides a process and tools, not requirements. Risk as per ICH Q9 – The combination of the probability Read more about ICH Q9 – Quality Risk Management[…]

Best Practices of CSV & 21 CFR Part 11 Compliance

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The cost of compliant CSV can be as much, if not more than the remaining tasks required for system development and implementation. A balance must be reached in order to achieve compliance while minimizing cost of CSV. There are specific industry best practices for effectively controlling the cost of system validation. The cost of longer-term Read more about Best Practices of CSV & 21 CFR Part 11 Compliance[…]

Data Integrity & 21 CFR Part 11 Compliance Requirements

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21 CFR Part 11 is a section in the Code of Federal Regulations (CFR) that sets forth the United States Food and Drug Administration’s (FDA) guidelines on using: Electronic records (ER), and electronic signatures (ES). Each title of the CFR addresses a different regulated area: 21 CFR relates to Pharmaceuticals and Medical Devices. Part 11 Read more about Data Integrity & 21 CFR Part 11 Compliance Requirements[…]

Supplier Management Key elements & Guidance

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A Supplier Management Program should have below elements : Definition of the product’s quality requirements Evaluation of alternative suppliers Selection of the most appropriate suppliers Conduct joint quality planning Co-operation during relationship period Validation of conformance to requirements Certification of qualified suppliers Conduct quality improvement plans Creation and use of supplier rating Guidance for Supplier Read more about Supplier Management Key elements & Guidance[…]