December 20, 2018 | FDA Release New Data Integrity Guidance

News : 20 Dec 2018

Data Integrity remains a key focus for the FDA in 2018, now five years on since the subject was first officially addressed by FDA Guidance.  In a new 17-page Guidance, ‘Data Integrity and Compliance with Drug CGMP’, released December 12, 2018, the FDA aims to ‘clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs (including Biologics)’ with responses to 18 important questions pertaining to Data Integrity in Drug and Biologics manufacturing.

Data Integrity and Compliance with Drug CGMP’ responds to questions such as ‘Can electronic signatures be used instead of handwritten signatures for master production and control records?’ and ‘How should blank [electronic] forms be controlled?’ as well as providing clarification around audit trail best practices, including ‘Who should review audit trails?’ and ‘How often should audit trails be reviewed?’


8. How often should audit trails be reviewed? 

If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review. For example, § 211.188(b) requires review after each significant step in manufacture, processing, packing, or holding, and § 211.22 requires data review before batch release. In these cases, you would apply the same review frequency for the audit trail. If the review frequency for the data is not specified in CGMP regulations, you should determine the review frequency for the audit trail using knowledge of your processes and risk assessment tools. The risk assessment should include evaluation of data criticality, control mechanisms, and impact on product quality.  Your approach to audit trail review and the frequency with which you conduct it should ensure that CGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven.”

– Data Integrity and Compliance with Drug CGMP | December 12, 2018

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