National Technical Reports Library

The National Technical Information Service acquires, indexes, abstracts, and archives the largest collection of U.S. government-sponsored technical reports in existence. The NTRL offers online, free and open access to these authenticated government technical reports. Technical reports and documents in its repository may be available online for free either from the issuing federal agency, the U.S. Government Publishing Office’s Federal Digital System website, or through search engines.

Details

Medical Device Good Manufacturing Practices Manual (5th Edition).

PB92111657

Publication Date	1991
Personal Author	Lowery, A.; Puleo, J.
Page Count	440
Abstract	The manual discusses requirements of the Good Manufacturing Practices (GMP) regulation that firms marketing medical devices must consider when they establish specifications for devices, or when they manufacture, contract manufacture, process, repack, or relabel finished medical devices intended to be commercially distributed. The manual contains articles that explain the various GMP requirements such as calibration, device master records, component control, etc. It also contains examples of forms, procedures, decals, etc. Manufacturers may use these as guidelines when developing their GMP or quality assurance system. The manual includes total quality assurance systems and preproduction quality because of their importance to anyone who manufactures a medical device. The last chapter covers the inspections performed by Food and Drug Administration investigators to determine if medical device firms are in compliance with the GMP requirements.
Keywords	Medical equipment Quality assurance Requirements Manuals Regulations Calibrating Evaluation Labels Packaging Inspection Auditing Quality control Foreign technology GMP(Good Manufacturing Practices) FDA(Food and Drug Administration)
Source Agency	Center for Devices and Radiological Health
NTIS Subject Category	95C - Biomedical Instrumentation & Bioengineering 44H - Health Care Technology 41G - Quality Control & Reliability 94B - Quality Control & Reliability 88E - Reference Materials
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	Supersedes PB88-132139. Also available from Supt. of Docs. Also pub. as ISBN-0-16-035844-2.
Document Type	Technical Report
NTIS Issue Number	199203

Medical Device Good Manufacturing Practices Manual (5th Edition).

Medical Device Good Manufacturing Practices Manual (5th Edition).
PB92111657

Publication Date	1991
Personal Author	Lowery, A.; Puleo, J.
Page Count	440
Abstract	The manual discusses requirements of the Good Manufacturing Practices (GMP) regulation that firms marketing medical devices must consider when they establish specifications for devices, or when they manufacture, contract manufacture, process, repack, or relabel finished medical devices intended to be commercially distributed. The manual contains articles that explain the various GMP requirements such as calibration, device master records, component control, etc. It also contains examples of forms, procedures, decals, etc. Manufacturers may use these as guidelines when developing their GMP or quality assurance system. The manual includes total quality assurance systems and preproduction quality because of their importance to anyone who manufactures a medical device. The last chapter covers the inspections performed by Food and Drug Administration investigators to determine if medical device firms are in compliance with the GMP requirements.
Keywords	Medical equipment Quality assurance Requirements Manuals Regulations Calibrating Evaluation Labels Packaging Inspection Auditing Quality control Foreign technology GMP(Good Manufacturing Practices) FDA(Food and Drug Administration)
Source Agency	Center for Devices and Radiological Health
NTIS Subject Category	95C - Biomedical Instrumentation & Bioengineering 44H - Health Care Technology 41G - Quality Control & Reliability 94B - Quality Control & Reliability 88E - Reference Materials
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Devices and Radiological Health.
Supplemental Notes	Supersedes PB88-132139. Also available from Supt. of Docs. Also pub. as ISBN-0-16-035844-2.
Document Type	Technical Report
NTIS Issue Number	199203