Through our network of over 42,000 people in 1,000 laboratories gmp compliance audit pdf offices in 100 countries, Intertek provides quality and safety solutions to a wide range of industries around the world. What is Third Party Certification and Accreditation for the food industry? Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Anchored in Intertek’s extensive social compliance expertise, WCA has emerged as a powerful tool for evaluating, benchmarking and continuously improving supplier workplace conditions. The program is supported by a web-based platform that automates and streamlines the audit process, increasing efficiencies for all supply chain partners. Need help or have a question? Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections. Our internal audit procedure is due for revision. It currently states that internal audit reports will not be made available to inspectors from regulatory agencies and that the reports can be destroyed once all corrective actions have been completed. Internal audits, or self-inspections as they are called in the EU, help assess a pharmaceutical company’s quality system and compliance status.
When a company performs internal audits, it is essential to have a procedure in place, which your company does have. The US and the EU have different regulations regarding internal audit records. In short, if you destroy your internal reports, you would be compliant with US regulations, but not with EU regulations. Considering this, your procedure would be compliant. Reports should contain all the observations made during the inspections and, where applicable, proposals for corrective measures.
Statements on the actions subsequently taken should also be recorded. Therefore, self-inspection reports must be prepared, retained in accordance with documentation retention requirements, and most importantly, be provided to the regulators when requested. In fact, refusal to provide the internal audit report in an inspection can be considered a critical observation. EU inspectors are known to have terminated inspections because of critical observations. The manufacturer shall conduct regular internal audits and follow-up on the findings. To recap, you are still compliant with US regulations, but as detailed above, this is not the case for EU regulations. It is good practice to design your quality system so that it complies with even the most stringent regulations that apply to your business.
FDA, CFR Title 21, Part 820. FDA, CFR Title 21 Part 211, www. When referring to this article, please cite it as, S. MHRA Inspectorate Blog on cGMP Topics Recently, the UK’s MHRA has run a series of blog postings on data integrity – what it is and what it ain’t from the regulators perspective. The last one is of particular importance because so often cGCP compliance gets the short end of the stick when it comes to public data integrity enforcement.
Responsible Conduct of Research at Northern Illinois University This collection of webpages includes a nice summary of data integrity control points around data collection for scientists and researchers. It includes elements of both quality control and quality assurance, and provides additional reference documents. 4 Security Standards: Technical Safeguards newsletter from 2007 is well worth your time. FDA’s Application Integrity Policy – Points to Consider Primarily used for submission-related data integrity concerns, parts of FDA’s Application Integrity Policy are important to review regardless of where you sit on the cGXP continuum. Of course, this all presumes you haven’t already bookmarked Cerulean’s resource library for data integrity-related articles, case studies, interviews, and so on. Just these four terms have caused a great deal of consternation and confusion in the industry, and MHRA sets out to provide a framework within which to consider controlling the conversation and the data integrity expectations.
The extent to which all data are complete, consistent and accurate throughout the data lifecycle. In order to ensure data accuracy, legibility, consistency, originality, attributability, completeness, etc. Computerized system validation is only going to go so far. All four stages of the data lifecycle need to be controlled, especially if the firm has a supplier create, manage, use, store, transmit, et al regulated data on its behalf. Raw data must be contemporaneously and accurately recorded by permanent means. Conversely, for data that are used to generate chromatographs, spectrographs, and other visual analyses, the raw data will likely need to be retained in its original, digital form. In other words, there is no getting around the need for data integrity controls in the 21st century.
True Copy is an exact verified copy of an original record. While digital data integrity has been an established legal and regulatory principle for several decades now, the controls around data integrity are constantly evolving as technology, businesses processes, and organizations evolve. Data integrity is an issue of trust. Either all the regulated day your organization generates, obtains from suppliers, uses, relies upon, and archives is trustworthy or it isn’t. You can’t have a little bit of data integrity just as you can’t be a little bit pregnant.
Your data is either trustworthy or it isn’t. If you need help with regulated data integrity chain-of-custody controls on any or all of the four stages of the data lifecycle, contact a data integrity expert through my firm’s website, Ceruleanllc. Why does FDA object to using actual samples to perform system suitability testing? Why is FDA concerned with the use of shared login accounts for computerized systems?
The answer to the latter should be obvious. You can’t prove the authenticity of the data or hold the data owner accountable if you cannot identify who actually created or modified the data. Shared logins blur the lines and hide clarity around who created, or modified, or destroyed data. In some situations, the use of actual samples to perform system suitability testing can be a means of testing into compliance.
All data should be included in the data set that is retained and subject to review unless there is documented scientific justification for its exclusion. One way to read this is to state that the use of actual samples can be too tempting for some firms. This is FDA’s logic and aside from some unique, one-off situations, it’s difficult to disagree. What are some specific trigger events that should cause us to re-evaluate – or at least take a quick review of – our progress on data integrity and Part 11 compliance? Part 11 or data integrity, even if it may not appear – at first blush – that the guidance applies to your business.