Spreadsheets such as Excel used in FDA regulated environments should be verified for accuracy and calculations used in the spreadsheet program should be documented. This became clear during a recent inspection of a prescription drug manufacturer which resulted in a warning letter. For example, the letter reads: "You continued to release products based on assay results generated by the spreadsheet that have not been verified for accuracy.". Furthermore the FDA noted that: "Your laboratory records did not include a record of all calculations performed in connection with laboratory tests as required by 21 CFR §211.194(a). For example, the notebook does not document reference to the spreadsheet calculation used to generate the results. Your SOP omits instructions to include in the notebook the reference to the spreadsheet calculation used to generate the results, as well as the raw data and calculations." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-237. To learn how to validate Excel Spreadsheets for FDA regulated environments attend the audio seminar "Validation of Excel Spreadsheets in Regulated Environments".

Do all EU GMP Inspections Cover the Quality Risk Management Process?

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) published a set of Q&As related to the GMPs and Quality Risk Management. The first question was "Do all EU GMP Inspections Cover the Quality Risk Management Process". The answer is a clear yes. Quality risk management is part of the Quality system that is included in all GMP inspections. "Inspectors will review the QRM system as part of the Quality Systems section of the inspection (along with complaints, recalls, deviations, and product quality reviews etc).". The Q&As are published on the MHRA website.

Again and Again, Part 11 Related Deviations Cited in FDA Warning Letter

During an inspection of pharmaceutical manufacturing facility the FDA found several deviations related to Part 11. Multiple persons had access to one user account. The letter states "Your firm has not exercised appropriate controls over computer or related systems to assure that changes in control records or other records are instituted only by authorized personnel. For example, one user account is established for two analysts to access the laboratory instrument's software on the computer system attached to HPLC systems" In addition, the user accounts provided full system administrative rights. Furthermore, there were no data security protocols that describe the user's roles and responsibilities in terms of privileges to access, change, modify, create, and delete projects and data. The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-242. To learn everything about FDA' new inspection practices attend the audio seminar " How to Prepare Yourself for FDA's New Part 11 Inspection Program".

FDA Issued Final Rule on Safety Information During Clinical Trials

On September 28, 2010, the Food and Drug Administration issued final regulations addressing the safety reporting requirements for investigational new drug applications (INDs) found in 21 CFR part 312 and for bioavailability and bioequivalence studies found in 21 CFR part 320. This final rule is expected to improve the quality of safety reports submitted to FDA, thereby enhancing the safety of patients in clinical trials. The final rule lays out clear, internationally harmonized definitions and standards so that critical safety information about investigational new drugs will be accurately and rapidly reported to the agency, minimizing uninformative reports and enhancing reporting of meaningful, interpretable information. Along with this final rule, the FDA also issued a draft guidance for industry and investigators that provides information and advice about the new requirements and other information. In addition, FDA published Q&As related to the new rule.

New Part 11 Compliance Package Available as Download

The popular Labcompliance Part 11 Package is now available as download version, in addition to traditional CD/Binder Version. The content has also been updated with new 9 SOPs, two new audio seminars, 8 new forms and 4 new case studies for trouble free implementation. The new package is ideally suited to prepare companies for upcoming FDA Part 11 inspections with focus on security, integrity and availability of e-records. For example, checklists, the step-by-step implementation plan and procedures have been updated accordingly. For details on content and ordering, click here.

FDA 'Advice' on Validation and Use of Excel®

Excel is frequently used in laboratories, offices and manufacturing as sophisticated calculator. Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. The new Annex 11 for EU GMP's and GAMP®5 also include chapters on Spreadsheets. To learn everything about FDA's and other regulatory expectations and enforcement practices for using Excel click here.

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the SOP "Handling of Laboratory Test Samples". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on October 4, 2010). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.