Category: Articles & Best Practices

SOP – Standard Operating Procedure best practice

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International Conference on Harmonization (ICH) defines a Standard Operating Procedure (SOP) as “detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55). It is Founded in Federal regulations (GXP) guidelines SOP – Common Characteristics Lists general information that is to be utilized throughout any process (not too detailed) Describes Read more about SOP – Standard Operating Procedure best practice[…]

Basel II Operational risk – best practices

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What is Operational Risk ? The Basel II accord on banking supervision defined operational risk as the risk of loss resulting from inadequate or failed internal processes, people and systems or from external events. Legal risk would be included in this definition according to the Basel committee, but not strategic or reputational risk Operational Risk Read more about Basel II Operational risk – best practices[…]

Pet Food Labeling Guidelines in USA & Canada

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Enforcement Authority in USA Pet food labeling is regulated at two levels.  National Level : The federal regulations, enforced by the United States Food and Drug Administration (FDA), establish standards applicable for all animal feeds: proper identification of product net quantity statement manufacturer’s name and address and proper listing of ingredients. State Level : Some Read more about Pet Food Labeling Guidelines in USA & Canada[…]

When do we need 510(K) ?

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510(K) is required under following conditions. Introducing a device into commercial distribution for the first time Different intended use for a device already in commercial distribution Indicated by claims made for a device in labeling/advertising Note: Prescription use to over-the-counter use is a major change in intended use Change to a device that could significantly Read more about When do we need 510(K) ?[…]

Food Recall steps and recall plan components

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Steps of food recall: Notification of complaint —>Initial risk assessment —-> Assemble recall team –>Gathering of information –> Determine risk level —> Regulatory body communication —>customer notification —>Retrieve products —>Store faulty products —>Investigate the root cause –>Dispose the product     Recall team comprise of :  Plant Manager Production manager Quality manager Warehouse manager Sales Read more about Food Recall steps and recall plan components[…]

Document control as per ISO 13485

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Why it is Required to have Document Control ? It is required by both FDA (in Federal, Food, Drug, and Cosmetic Act) and European Community (in ISO 13485) Has always been a requirement, from 1976 (GMPs) and 1996 (ISO) Cited regularly by both FDA inspectors and notified body auditors as deficient Often ignored by upper Read more about Document control as per ISO 13485[…]

Cleaning validation and Labelling Requirement for reusable medical devices

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FDA regulatory requirements as follows Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval) 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user: Detailed cleaning instructions, including disassembly. Detailed disinfection & sterilization instructions with specific sterilization parameters. Expected end of life & how Read more about Cleaning validation and Labelling Requirement for reusable medical devices[…]

USE error and medical device recall

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Though the word USE error is not used officially. The definition of USE error is “Act or omission of an act that results in a different outcome than intended by the manufacturer or expected by the USER, which may result from a mismatch situation between USER, man-machine interface, task and/or environment.” AAMI HE74:2001 Many research Read more about USE error and medical device recall[…]

Cleaning validation and Labelling Requirements for reusable medical devices

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FDA regulatory requirements Most of the complex medical device instruments require premarket notification [510(k) or even a PMA (premarket approval) 510(k) and PMA Guidance Documents include requirements for reprocessing instructions for the user: Detailed cleaning instructions, including disassembly. Detailed disinfection & sterilization instructions with specific sterilization parameters. Expected end of life & how this can Read more about Cleaning validation and Labelling Requirements for reusable medical devices[…]

How to Create a Data Governance Framework for Data Integrity

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Data Governance provides a framework for dealing with the challenges around data compliance and regulation which aids in the management of the availability, usability, integrity, quality, consistency, and security of the data employed in an enterprise and helps organizations meet compliancy with legislative laws, regulations, and mandates. Data Governance Framework Organization : It requires representative participation Read more about How to Create a Data Governance Framework for Data Integrity[…]