In mid-April 2016, the FDA published a draft guidance clarifying the role of data integrity in current good manufacturing practice (cGMP) for drug products, as required under 21 CFR parts 210, 211, and 212. The draft guidance, entitled “Data Integrity and Compliance with CGMP,” was published in response to an increasing number of data integrity violations being observed during FDA cGMP inspections.
FDA’s expectation is that all data submitted to the Agency is reliable and accurate. This is of paramount importance because, without accurate data, the Agency’s mission to protect and promote the public health and ensure the safety, efficacy, and quality of drugs through regulatory decisions “based on the best available science” is made very difficult. In the recent past, FDA has seen an increase in the occurrence of data integrity-related cGMP violations. These violations typically lead to a number of regulatory actions, including warning letters, import alerts, and consent decrees.
According to 21 CFR parts 210.1 and 212.2, “CGMP sets forth minimum requirements to assure that drugs meet the standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act) regarding safety, identity, strength, quality, and purity.” Furthermore, the requirements set forth in parts 211 and 212 that involve data integrity, include the following:
In its draft guidance, FDA clarifies the definitions of the following terms as they relate to cGMP records:
Presented in question and answer format, FDA’s recent draft guidance “addresses specific questions about how data integrity relates to compliance with CGMP for drugs, as well as more general data integrity concepts.” Along with the definitions provided above (which are presented as the answer to the first question in the document), the draft guidance contains 17 additional questions and the associated answers. Some of these include:
FDA states that any and all data “created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see §§ 211.22 and 212.70) and maintained for CGMP purposes ((e.g., § 211.180).” Data may only be excluded from the release criteria decision-making process if a valid, documented, and scientific justification is provided.
In short, yes. FDA states that “a workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be checked through validation.” Furthermore, FDA goes on to say that “if you validate the computer system, but you do not validate it for its intended use, you cannot know if your workflow runs correctly.”
FDA explains that “when login credentials are shared, a unique individual cannot be identified through the login and the system would thus not conform to the CGMP requirements in parts 211 and 212.” In order to ensure product quality, FDA mandates that all systems controls be designed in a manner compliant with all cGMP requirements.
According to the draft guidance, “when generated to satisfy a CGMP requirement, all data become a CGMP record. You must document, or save, the data at the time of performance to create a record in compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and 211.160(a). FDA expects processes to be designed so that quality data required to be created and maintained cannot be modified.” Furthermore, FDA states that it is not acceptable to:
For additional information on these or other questions and answers provided in the document, view FDA’s full draft guidance.
Do you need help preparing for an FDA (or another regulatory agency) inspection? Do you want to ensure that you are in compliance with all of FDA’s cGMP requirements? We can help. Contact us today to learn more about our services and how we can help you achieve regulatory compliance.
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