Another of drug and medical device industries is called
Good Manufacturing Practices (GMP)
. These regulations describe the minimum requirements that governments consider necessary for the production of drugs and medical device products. Although there are many types of GMP regulations, they are common in that they address the manufacturing methods, facilities, testing, packaging, storage, distribution, installation,and servicing for medical device and drug operations. They have, however, not been common in their inclusion of standards that address the development (design control) requirements for products.This has recently become a signifcant issue. It has resulted in countries and independent standard organizations updating the requirements to include preproduction requirements. The new replace-ment regulations for the United States Medical Device GMPs, now called the Quality System Regulation (QSReg.), were revised in format to match ISO 9001, but more importantly, were revised to include design-control requirements.The concern for conformance to quality standards is not unique to the healthcare industry. The issuance of the ISO 9000 series by the International Organization for Standardization (ISO) was an attempt to solidify and standardize quality requirements for all types of suppliers regardless of the industries they serve. The ISO guidelines have been utilized by healthcare manufacturers to upgrade their quality proles to a recognizable “certified” level. ISO 9000 certification has become not only a recognized voluntary standard, but also a requirement for a company to market in the European Community (EC).
global acceptanceof the European standards 46001 and 46002, ISO developed its own global counterparts (ISO 13845and 13488) to the EN series. ISO 13845 and 13488 have now been accepted as global replacementsfor EN 46001 and 46002.Additional regulations and standards have evolved for bulk-chemical sources; one for active-ingredient manufacturers and one for excipient manufacturers. Both have been included in the bulk-chemical supplier audit checklist.To assure compliance with all requirements, quality auditing has become very complex. Auditsfor quality assurance have been substantially increased in number and diversi
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ed in scope. To operatein violation or noncompliance with regulations, standards, and guidelines could place an entirecompany in jeopardy. This vulnerability demands an effective system for monitoring compliance toassure that nonconforming areas will be recognized and addressed. Even the regulations and stan-dards strongly emphasize the management responsibility of monitoring its own quality systemthrough internal audits.In addition to previously mentioned regulations, standards, and guidelines, companies need toconcern themselves with product-speci
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c registration requirements. This particular product-speci
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cregistration
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eld is commonly referred to as “Regulatory Affairs.” Depending upon the organizationalstructure of the company, the compliance function may or may not be part of the regulatory-affairsdepartment. The compliance function is focused more on systems of control, whereas the regulatory-affairs function is focused more on particular individual product-registration requirements. It wouldrequire an encyclopedia to address all of the different product-registration requirements, especiallyon an international basis. Consequently, the subject matter in this manual is limited in scope to the
quality-system
aspects of compliance and not the
regulatory-affairs
aspects.The negative publicity that can arise from a
field-quality problem has always been a concern for drug and medical device companies. But in some countries, there are additional product liabilitie seven if no field-quality problems have occurred. If you market in the United States, the Food and Drug Administration (FDA) performs inspections on all drug and medical-device manufacturing operations. These inspections result in a formal inspection report that is completed by the FDA inspector or inspection team. If an inspector makes an observation about something that in his or her opinion could be considered as being in noncompliance with a regulation, this information is formally documented. The information gained from the inspection can be used as a basis for further regulatory actions, including product recalls. This can occur even if there are no known field quality problems. In the United States and for foreign
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rms shipping products to the United States, an inspector’sobservation is formally documented on a form FD483. When the inspector completes the inspection,a copy of the form FD483 may be left with the company or sent to it later. In addition to the noticeof adverse
findings (form FD483), an associated detailed report of the inspector’s surveillance activities is completed. This report is known as the Establishment Inspection Report (EIR). The EIR and form FD483 are available to the general public. The United States Freedom of Information Act(FOI) provides that the public may obtain copies of this inspection information. All of the observations and comments, except those that may reveal proprietary information, are available to the competition as well as the general public.
INTERNAL DEVICE MANUFACTURER/DEVELOPER AUDIT CHECKLIST
Scope:This checklist should be utilized to audit the internal facilities of a device manufacturer or developer. Internal operations that perform their own supply functions, such as electronic components, printing of materials, and so on, should utilize the appropriate “Supplier” audit checklist as an adjunct to the internal evaluation process.This checklist covers the following areas:A.Development and Design ControlB. Contract Review C.Purchasing D.Receiving/In-Process-Material Handling and StorageE. Production/Packaging/In-Process Control F.Final Inspection G. Final-Product Handling, Storage, Distribution, Installation, and Servicing H.Laboratories and CalibrationI. Computer Systems, Documentation Controls, and Quality RecordsJ.Internal AuditsK.TrainingL.Validation M.Facility Engineering and Maintenance N.Complaint Handling O.Medical Device Tracking, Reporting, and Recalls P.Quality Systems Management and Responsibility The questions in this checklist include references to:1.The United States Code of Federal Regulations 21 CFR, Part 820 — Quality System Regulation (QSReg.), Current Good Manufacturing Practice (CGMP) Requirements for Medical Devices.2.The United States Code of Federal Regulations 21 CFR, Sections 803.17 and 803.18 for Medical Device Reporting3.The United States Code of Federal Regulations 21 CFR, Section 806.10 for Corrections and Removals (Recalls)4.The United States Code of Federal Regulations 21 CFR, Section 821.25 for Medical Device Tracking.
5.The United States Code of Federal Regulations 21 CFR Part 11 — Electronic Records;Electronic Signatures. These questions are located in the Computer Systems, Documentation Controls, and Quality Records section of the checklist.
Note: References in the checklist column is indicated with squared brackets [ ].
6.International Organization for Standardization (ISO) documents, ISO 9001:1994, Quality Systems — Model for Quality Assurance in Design, Development, Production, Installation and Servicing, and ISO 9001:2000, Quality Management System — Requirements
7.International Organization for Standardization (ISO) documents ISO 13485:1996, Quality systems — Medical Devices — Particular Requirements for the Application of ISO 9001,and ISO 13488:1996, Quality Systems — Medical Devices — Particular Requirements forthe Application of ISO 9002
Note: References to ISO 13488 are indicated in the checklist by parenthesis ( ).
8.International Organization for Standardization (ISO) 10011–1:1990, 2:1991, and 3:1991;Guidelines for Auditing Quality Systems: Auditing; Quali
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cation Criteria for Quality System;and Management of Audit Programmes (American ISO equivalent: ANSI/ASQC Q10011–1,2, and 3)
Note: References to this standard are indicated under each appropriate question in thechecklist.
9.International Organization for Standardization (ISO) document 17025:1999, GeneralRequirements for the Competence of Testing and Calibration Laboratories
Note: References to ISO 17025 are indicated in the checklist by arrow brackets < >.
Because internal facility audits may be performed by more than one person, signature spaces are provided at the end of each section to provide a record of each individual auditor’s activities.
Date(s) of Audit___________________________________________Facility Location Name___________________________________________Address___________________________________________Audit Leader Name___________________________________________Title___________________________________________Audit Team Members Name___________________________________________Function on Team___________________________________________Name___________________________________________Function on Team___________________________________________Name___________________________________________Function on Team___________________________________________Name___________________________________________Function on Team___________________________________________Scope of Audit___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Applicable Regulations/Standards____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Opening Meeting Date_________________________________________________Attendees
Closing (Wrap-up) MeetingDate_______________________________________________Attendees_________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________Audit ReportDate Issued__________________________Date Response Received__________________________Date Response and Action Plan Approved__________________________Date Actions Completed__________________________Date Completed Actions Verified as Completed__________________________Date Completed Actions Verifed as Effective__________________________Date Closed Out__________________________Future Follow-up Items_______________________________________________________
QUALITY RATING SYSTEM
Rating Meaning Interpretation
3Excellent Item/area/system/knowledge is superior 2 Adequate Item/area/system/knowledge meets basic minimum requirements. 1Deficient Item/area/system/knowledge is weak and not up to acceptable standards.0Unsatisfactory Item/area/system/knowledge is missing or of a nature to warrant serious quality/compliance concerns.NA Not Applicable Question is not applicable to type of operation, or item unable to be addressed during the audit.
Comment:Some users of the checklist may find the responses to some questions difficult to quantify on a 0–3 scale and may prefer to use a simple “yes” or “no” approach. In such cases,a “yes” should be assigned a “2” value, and a “no” should be assigned a “0” value.
CHECKLIST RESULTS AND RATING
Audit Findings Summary
Number of questions rated excellent( )Times 3 = ( )Number of questions rated adequate( )Times 2 = ( )Number of questions rated deficient( )Times 1 = ( )Number of questions rated unsatisfactory( )Times 0 = ( )Total Number of Questions Answered =( )Rating Total = ( )“Rating Total” divided by “Number of Questions Answered” = _______ Audit Rating
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