Lawrence Hall Consultants Limited

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GMP MANAGEMENT SYSTEMS

Lawrence-Hall Consultants Ltd
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• QUALITY SYSTEMS
• FDA QS/GMP
• DAMAS
• PRESENTED BY
• DAVID G LAWRENCE

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GMP MANAGEMENT SYSTEMS

• WHY DO DENTAL LABORATORIES REQUIRE A GMP SYSTEM ?
• FDA REQUIREMENT
• All Dental Laboratories are required to operate a
  GMP System to include the applicable sections of
  FDA document 21CFR 820

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GMP MANAGEMENT SYSTEMS

• FDA QS/GMP is based upon tried and tested quality
  management system procedures. The format of the
  FDA QS/GMP requirement is similar to the now
  obsolete ISO90001994 Quality Management System
  requirements with additional elements
  specifically related to medical devices
• The GMP system elements ensure that
• All activities from the receipt of the doctors
  prescription through to despatch of the final
  product are carried out in a planned and
  controlled manner by personnel proven to be
  competent for the assigned task
• The materials used are FDA approved.
• Product recall may be achieved (if and when
  applicable)
• Compliance to regulatory requirements is
  demonstrated

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GMP MANAGEMENT SYSTEMS

• HOW DOES A LABORATORY ENSURE COMPLIANCE?
• In order to achieve and demonstrate compliance
  to FDA QS/GMP requirements, various essential
  functions must be documented in the form of
  written procedures or work instructions.
• The average dental laboratory requires 9 10
  written procedures
• Certain elements of the FDA QS/GMP are not
  applicable to class 1 devices. These elements may
  be excluded from the system

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GMP MANAGEMENT SYSTEMS

• HOW COMPLICATED DOES A PROCEDURE NEED TO BE?
• Each procedure should describe how the
  particular activities are undertaken, who is
  responsible for them and cross reference to
  associated activities, records, documentation
  etc.
• Procedures must include all of the requirements
  of the relevant section of FDA QS/GMP yet be
  comprehensive and uncomplicated. In many cases a
  procedure can be reduced to the form of a flow
  chart
• Work instructions are in the form of step by
  step instructions
• Most laboratories do not require detailed work
  instructions as dental technicians are trained
  persons

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• HISTORY OF GMP SYSTEMS
• ISO9001 was introduced in 1994 as a general
  purpose quality system enabling companies to
  demonstrate to customers that all processes were
  carried out in a planned and controlled manner.
  The emphasis of the system was placed on the
  activities occurring within the manufacturing
  area
• ISO13485 was introduced in 1996 using
  ISO90011994 as its foundation in order to ensure
  that all aspects necessary for the control of
  manufacture of medical devices were covered,
  these included product recall, labeling etc.

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GMP MANAGEMENT SYSTEMS

• Both ISO 9001 and ISO13485 are full blown QA
  systems with ISO 9001 being a general standard
  for all industries and ISO13485 being an extended
  version of ISO 9000 aimed at medical device
  manufacturing in a mass production environment.
• Both of these standards have now been revised
  with the emphasis now placed upon the measurement
  and monitoring of processes and the subsequent
  analysis of the results.
• The independent audit of these systems
  concentrates on evidence of the analysis of data
  and the subsequent follow up actions
• DAMAS was introduced in 1997

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GMP MANAGEMENT SYSTEMS

• WHERE DOES DAMAS FIT INTO THIS ?
• Like the FDA QS/GMP, DAMAS is based upon
  the original ISO90011994
• DAMAS was written by Dental Laboratory
  Owners and Technicians as an industry specific
  standard for the benefit of dental laboratories.
  It is less prescriptive than ISO90012000 and
  ISO134852003 and less costly in all aspects of
  implementation.
• DAMAS satisfies the majority of the FDA
  QS/GMP requirements that are applicable to dental
  laboratories and concentrates on the hands on
  activities occurring within the manufacturing and
  process areas
• The independent audit of the system concentrates
  on the manufacturing and process areas as
  detailed in FDA QS/ GMP

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GMP MANAGEMENT SYSTEMS

• Myths.
• Contrary to popular belief DAMAS does not
• Create monumental amounts of paperwork
• Involve hours of management time
• Require interference from outside bodies
• Tell you how to run your business
• It can, however, be of great assistance!

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GMP MANAGEMENT SYSTEMS

• The following comparison chart compares the FDA
  QS/GMP and DAMAS elements
• FDA QUALITY SYSTEM REGULATION
  DAMAS SPECIFICATION
• SUBPART A GENERAL PROVISIONS
• 820.1 Scope Part 1
• 820.2 Normative Reference Part 2
• 820.3 Definitions Part 3
• SUBPART B - QUALITY SYSTEM REQUIREMENTS
• 820.20 Management Responsibility Part 4.1
• 820.22 Quality Audit Part 4.15
• 820.25 Personnel Part 4.6
• SUBPART C DESIGN CONTROLS
• 820 30 Design Control Not applicable to Custom
  Made Devices
• SUBPART D DOCUMENT CONTROLS
• 820.40 Document Controls ------
• SUBPART E PURCHASING CONTROLS
• 820.50 Purchasing Controls Part 4.4

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GMP MANAGEMENT SYSTEMS

• SUBPART G PRODUCTION PROCESS CONTROLS
• 820.70 Production Process Controls Parts 4.5,
  4.7 4.8
• 820.72 Inspection, Measuring Test
  Equipment Part 4.7
• 820.75 Process Validation Part 4.9
• SUBPART H ACCEPTANCE ACTIVITIES
• 820.80 Receiving, In-process Parts 4.4, 4.5
  4.9
• finished Device Acceptance
• 820.86 Acceptance Status
  Part 4.4, , 4.5 4.9
• SUBPART I NONCONFORMING PRODUCT
• 820.90 Nonconforming Product Parts 4.9, 4.14
• SUBPART J CORRECTIVE PREVENTIVE ACTION
• 820.100 Corrective Preventive Action
  Parts 4.9 4.14
• SUBPART K LABELLING PACKAGING CONTROLS
• 820.120 Device Labeling Part 4.13
• 820.130 Device Packaging Part 4.10
• SUBPART L HANDLING, STORAGE, DISTRIBUTION
  INSTALLATION
• 820.140 Handling Part 4.10

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GMP MANAGEMENT SYSTEMS

• SUBPART M RECORDS
• 820.180 General Requirements Part 4.11
• 820.181 Device Master Record 820.181 (a)
  Parts 4.3
• Process Specifications 820.181 (b) Part 4.5
• QC procedures Specs 820.181 (c) Part 4.5
• Packaging Labeling 820.181 (d)) Parts
  4.10, 4.13
• Installation/servicing 820.181 (e) not
  applicable
• 820.184 Device History Record Part 4.5
• 820.186 Quality System Record Part 4.2
• 820.198 Complaint Files Part 4.14
• SUBPART N SERVICING
• 820.200 Servicing Not applicable to Custom Made
  Devices
• SUBPART O STATISTICAL TECHNIQUES
• 820.250 Statistical Techniques Not applicable

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GMP MANAGEMENT SYSTEMS

• Certain elements within the FDA QS/ GMP
  requirements are more in depth than those in
  DAMAS, Sections 820.40 (Document Control) and
  820.150 (Storage) are examples
• However, DAMAS being a guidance document
  allows for the emphasis within the documentation
  to be enhanced on defined subjects
• The alternative standards (ISO 90012000
  ISO 134852003) are far more formalized
  international standards and do not allow the
  emphasis within any element to be enhanced to
  such an extent
• The ISO standards and DAMAS are subject to
  certification by an independent certification
  authority.
• Within the USA, via NADL, Anglo Japanese
  American Registrars Ltd (AJA) are the recognised
  certification body for DAMAS

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GMP MANAGEMENT SYSTEMS

• CLASS 2 DEVICES
• Laboratories manufacturing class 2 devices
  (sleep apnea / snoring devices) must register
  with the FDA and also be able to demonstrate that
  their system considers the full requirements of
  FDA QS/GMP for class 2 devices. This includes
  Section 820.30 (Design Controls)
• Once again, DAMAS can be adapted to include
  the full FDA QS/GMP requirements for Class 2
  Medical Devices

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GMP MANAGEMENT SYSTEMS

• MAJOR BENEFITS OF DAMAS
• Improved efficiency and productivity
• Application of good management disciplines
• Ensuring customer needs are understood and
  satisfied
• Provides competitive edge
• Increased customer confidence (use of DAMAS logo)
  
• Potential for increased profitability
• Reduced waste of materials and manpower
• Reduced risk and liability
• Appropriate for extension to accommodate Sleep
  Apnea and all similar class 2 devices
• FDA GMP approval