Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA INVESTIGATORS WILL ABBREVIATE ROUTINE INSPECTIONS

Executive Summary

FDA INVESTIGATORS WILL ABBREVIATE ROUTINE INSPECTIONS of firms that have good compliance records and have not made significant operational changes. FDA headquarters recently advised its field offices that an "abbreviated" approach should be taken during routine inspections when conditions at the firm do not appear to warrant a full investigation. The abbreviated inspections will satisfy the agency's biennial inspection requirement, the new field guidance states. Procedural differences between an "abbreviated" and a "full" inspection were specified in a new section added to the drug process inspection compliance program. The agency maintains a collection of its programs called the "FDA Compliance Program Guidance Manual." The policy manual is used by field investigators and managers as a reference guide in carrying out their surveillance activities. ]EDITORS' NOTE: The new section of the drug process compliance program on abbreviated vs. full inspections, together with an in-depth analysis, is included in the March issue of "The Gold Sheet." Contact Edward Picken at (301) 657-9830 for further information.[ In an abbreviated inspection, the manual states, the FDA investigator should perform only "a brief inspection of the firm's manufacturing facility including master records and batch records in a representative number of products manufactured by the firm." FDA advises that the products selected for special attention should include those with a history of previous problems. A brief inspection of the laboratory should also be included and a spot-check made of a limited number of test records from at least one NDA/ANDA product "to assure that batches are being subjected to adequate testing for conformance to specifications." If the abbreviated inspection reveals no "significant" objectionable conditions, the new guidance states, it "is adequate for routine coverage and will satisfy the biennial inspection requirement." Reporting requirements in this case are also limited, the manual says, and need only include a brief summary describing the scope of the inspection, the persons interviewed and a description of any changes, together with a listing of any adverse findings.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

ID1122310

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel