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Labcompliance News, October 2006

October 15, 2006

 

FDA Releases Final Industry Guidance on Handling OOS Test Results

On October 12, 2006, the FDA announced the release of the final Guidance Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production. The draft version has been published in 1998 and although it was in draft form it was one of the most important FDA guidance documents. Many deviations cited in FDA warning letters have been related to OOS test results. With the right tools in place such as SOPs and forms the new guidance is expected to provide more clarification.
In a new Audio Seminar you can learn about the basics of OOS and what’s new in this guidance. And you receive 10+ up-to-date best practices for easy implementation. The guidance can be downloaded from the FDA website.

October 15, 2006

Obsolete Documents should be Promptly Removed from all Points of Use

Deviations related to procedures and other documents are frequently cited in FDA warning letters. Typical deviations are: procedures missing, procedures are not adequate or procedures are not followed. Most recently the FDA cited a company for not promptly removing documents from all points of use. Furthermore, the company was cited for failing to conduct, document, and maintain the results of the verification testing of each change of equipment to determine whether or not each change affect operations and performance specifications. In addition the FDA said the firm lacked adequate production and process controls, adequate change control, and documentation of training. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

October 15, 2006

Service Records not Maintained, FDA Warning Letter Says

GxP regulations require equipment maintenance and repair records to be maintained as long as data generated by the equipment, e.g., by automated systems. The FDA made this very clear in a warning letter from August 2006. According to the warning letter, the company failed to maintain service reports for serviced devices, as required by 21 CFR § 820.200(d). The letter also gave recommendations on what type of information should be included in the service records: "For example, your firm failed to maintain service reports for each device returned to your firm for servicing or repair (e.g. the name of the device, the date of service, the individual(s) servicing the device, the service performed, and the test and inspection data)." The company also failed to adequately identify and document all possible risks associated with your device and to document the results of your firm's risk analysis. Furthermore, the company was cited for inadequate handling of complaints, e.g., thy company failed to document the results of its analysis or evaluation of emails of complaints and service reports in order to identify existing and potential causes of nonconforming product. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

October 15, 2006

"Calibration of Instruments not always Conducted at Suitable Intervals" draws FDA warning letter

The Warning Letter was issued based on conditions found during an inspection conducted between January 23 and February 8, 2006. In addition to problems with instrument calibration, the firm failed to always clean, maintain and sanitize equipment at appropriate intervals. The company was also cited for missing review of laboratory records by a second person. "There were not always the initials or signature of second person showing that the original records have been adequately reviewed by a second person". Other violations included the fact that "Laboratory records did not always include a description and identification of the sample received for testing, the date the sample was taken, the date the sample was received for testing and the data derived from testing." Other deviations were related to inadequate buildings and to inadequate failure investigations. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

October 15, 2006

New Article on Automated Dissolution Method Validation

David Fortunato of Pharmaceutical Technology has published a Compliance Perspective on Dissolution Method Validation for Immediate-Release Solid Oral Dosage Forms on Automated Instrumentation. Automation can speed up the validation process and will allow to use dissolution more efficiently through all phases or drug development. The author also points out that when going from manual to automated method validation, dissolution scientists must have a good understanding on the potential effects from filtration, system interferences, carry over, cleaning parameters, and media replacement. The article with all technical details has been published in Pharmaceutical Technology and as of September 2006 is available on the publishers website.

October 15, 2006

FDA Expects a Procedure for Evaluation of Suppliers, Contractors, and Consultants.

The FDA made this clear in a recent Warning Latter. "Your firm failed to establish procedures for the evaluation of suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). For example, there is no documentation to demonstrate that your firm has evaluated the importer or is aware of the manufacturer from Asia supplying the reagents used to produce the Hemoglobin Alc Reagent", the letter said. The letter furtherer stated that there are no clear agreements from the suppliers to notify you of changes". The firm also failed to validate computer software used to control automated production and quality system operations. The letter specifically mentioned that firm has not validated the software used to produce labels and manage complaints. Other deviations were related to: No or inadequate procedures for design control, inadequate review of complaints, inadequate procedures for implementing corrective and preventative action operations and no validation of the manufacturing processes. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts.

October 15, 2006

"Missing HPLC Peak not Investigated" Cited in FDA Warning Letter

FDA regulators inspected the facilities of a drug manufacturer between February 23 and March 22, 2006, and found practices that did not conform with U.S. CGMP requirements. For example, the company failed to investigate a missing HPLC peak. The letter reads: "The reference standard injection following assay and content uniformity testing of xxx, failed to show any peaks due to a leaking column. There was no documented investigation of this deviation, there was no assessment of the impact of the leaking column on the xxx analysis or any other analysis conducted with the same column, and the observation was made during the previous inspection, yet no investigation was conducted." The FDA also noted that there was no documented investigation regarding HPLC malfunctions requiring external repair. "Both HPLC xxx and xxx required repair in June 2005; however there is no documentation regarding whether the malfunctions impacted any analyses, and if so, what the corrective actions were regarding those analyses." In addition, the firm failed to adequately qualify a contract laboratory, to investigate the impact of a power failure, to identify analysts in records of test results and to ensure changes of methods by authorized persons. The Warning Letter can be downloaded from the Labcompliance Users Club. Non members can preview excerpts

October 15, 2006

FDA Announces Electronic Submissions Gateway

The Food and Drug Administration (FDA) is announced the availability of the FDA Electronic Submissions Gateway (ESG) for the receipt and processing of electronic submissions provided so that the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) can receive regulatory submissions electronically. The FDA ESG enables applicants to send applications and other submissions for review using the Internet, provides a single point of entry for these submissions, and fulfills goals identified in the Prescription Drug User Fee Act . Use of the FDA ESG is voluntary. Electronic format submissions may be made through the gateway or may continue to be made on physical media. Information on the FDA ESG is available on the FDA website.