FDA Inspection Readiness :-Inspection Readiness (IR) is a process of preparing for an inspection by a regulatory authority such as the FDA.
The FDA conducts official reviews of documents, facilities, records, and any other resources they deem to be related to the clinical trial, manufacturing, and operations.
Every pharma company is responsible for inspection readiness by providing training to employees and ensuring their understanding and application of policies, standards, and procedures. Pharma organizations should allocate the resources to assure that inspection readiness teams are in place to manage activities before, during, and after inspection.
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