Month: June 2021

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[…]