FDA inspection

A manufacturer of dmg chemicals is required to register with the FDA, and is subject to FDA inspection at least once every two years. Some manufacturers who make chemicals that incidentally are dmgs are impelled to drop the dmg designation from their labeling in order to avoid the exposure to inspection that registration entails. 

Aiken J. Panel criticizes FDA inspections of imported drugs. (CNN Online report, 9 June 2000.1 http //www.cnn.eom/2000/HEALTH/06/09/tainted.drugs/index.html. 

FDA regulations states that subjects must be informed about FDA inspections. 

Regulatory authorities play an important and active role to ensure regulatory compliance in the conduct of a clinical trial. Agencies such as the FDA inspect clinical studies. An inspection of a trial may reveal that the protocol is not being followed strictly, the Investigator may not be involved with the project as much as is expected, there may be a lack of patient care, changes to the protocol may not have been relayed to the IRB, and so on. In such cases, corrective actions have to be implemented immediately and the FDA must be satished before the trial can continue. Deficiencies found are reported on Form 583. 

Describe the system-based approach of FDA inspections, with reference to the surveillance and compliance inspection program. 

FDAnews. Surviving an FDA inspection, Washington Business Information, Virginia, 2001. 

If a testing facility refuses to permit an FDA inspection, none of the nonclinical laboratory studies or parts of studies conducted by that laboratory will be considered in support of an application for a research or marketing permit. The re-... 

Quality assurance unit records are exempt from routine FDA inspection and copying authority on the theory that such records are more likely to be complete and candid if they are exempt from review by the FDA. This exemption extends only to records of QA inspection and audit findings and records of corrective actions recommended and taken. All other QA records are subject to inspection and cop5dng by FDA. 

The historical file of SOPs documents what SOPs were in effect at any time during a laboratory s history. Because FDA inspection of a study often occurs years after the completion of that study, the historical file of SOPs will be of special use to an FDA inspector. Including the effective date on the SOP itself will aid in maintenance of the historical file and will also make it easier to ascertain if any one SOP manual contains the current version of any individual SOP. Accessory documentation of effective dates (e.g., in the transmittal memo for the distribution of SOPs) is permissible but not recommended. 

Methods of synthesis, fabrication, or derivation as well as identity (if estabhshed), strength, and purity characteristics of the material must be documented. Copies of this documentation must be included with study records and must be available for FDA inspection. In the case of contract testing facilities in which for proprietary reasons the sponsor may not wish to release such information to the contract lab, the contract facility should have written assurance from the sponsor that such documentation exists. 

However, a November 15-23, 1999, preapproval FDA inspection of BioPort s manufacturing renovations, which was more focused in scope and purpose than the 1998 surveillance inspections, resulted in BioPort receiving a FDA form 483 report with observations and possible deviations in some of the following areas validation, failure... 

FDA inspects manufacturers of drugs, biologies, and medical devices in relation to the submission of an NDA or BLA application. But independent of application reviews, it also inspects manufacturers periodically for compliance with such agency regulations as cGMPs. Some manufacturers are also inspected because they have a record of being out of compliance with FDA regulations. On some occasions, periodic compliance inspections coincide with inspections for NDA or BLA new product applications. 

Good Clinical Practices, Audits and Surviving an FDA Inspection... 

Principles and Practices of US Regulatory Affairs RA/QA 101 A Regulatory Compliance Workshop IND Training Workshop FDA Inspections... 

Compliance to FDA regulations by the health care industry over the last decade has been a major goal, including those companies intending to export their product to the U.S. market. As a result, the FDA inspects several companies around the world every year for their GMP and GLP... 

Quality assurance personnel must have the appropriate training, experience, familiarization with the manufacturing facility and products, enforced independence from the production chain of command, and the ability to review adherence to procedures, policies, and agreed-upon approaches to manufacturing quality pharmaceuticals. This helps to provide both an environment and a manufactured product that can withstand Food and Drug Administration (FDA) inspection and support a firm s reputation for quality products. 

Potentially result in shorter and fewer FDA inspections by lowering the risk of manufacturing problems... 

Corrective and preventive action (CAPA) is the term commonly used to describe the subsystem of a comprehensive quality system that deals with the systematic investigation, understanding, and response to quality issues including nonconformities. A corrective or preventive action may be initiated based on review and analysis of quality data from a variety of sources including adverse experiences, product complaints, quality audits, FDA inspections, third-party inspections, nonconforming materials reports, process control information, trend analyses, and other sources. 

The FDA inspects the facilities where the drug will be manufactured as part of the approval process. 

As discussed, the manufacture of suspensions presents additional problems, particularly in the area of uniformity. The development data should address the key compounding and filling steps that ensure uniformity. The protocol should provide for the key in-process and finished product tests, along with their specifications. For oral solutions, bioequivalency studies may not always be needed. However, oral suspensions, with the possible exception of some of the over-the-counter antacids, usually require a bioequivalency or clinical study to demonstrate their effectiveness. Comparison of product batches with the biobatch is an important part of the validation process. Make sure there are properly written protocol and process validation reports and, if appropriate, data for comparing full-scale batches with biobatch available during FDA inspection. 

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