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US Medical Device Regulations > cGMP and Quality System Design (Ch. 4) > Flashcards

cGMP and Quality System Design (Ch. 4) Flashcards

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1
Q

What does cGMP stand for?

A

cGMP: Current Good Manufacturing Practices

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2
Q

What does QSR stand for?

A

Quality System Regulation

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3
Q

What is the cGMP / QSR regulation for medical devices?

A

21 CFR 820 = medical device cGMP = QSR (Quality System Regulation)

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4
Q

What is the purpose of cGMP requirements?

A

To ensure that healthcare products in the US are manufactured according to a quality standard that ensures their safety and effectiveness

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5
Q

MED DEV: What is the quality-by-design (QbD) principle?

A

Quality-by-design (QbD): an approach where the product is designed and manufactured to conform to its specifications consistently following the manufacturing process - applies throughout the product’s lifecycle

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6
Q

MED DEV: What does QMS stand for?

A

QMS: Quality Management System

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7
Q

MED DEV: What is a QMS?

A

A framework or organizational structure that maximizes conformity with policies and procedures, promotes process efficiency and accuracy, and ensures product safety and efficacy

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8
Q

MED DEV: Who is responsible for the QMS?

A

Top management must be actively involved with the QMS - can delegate authority, but must take responsibility (est. quality policy, lead management reviews, and make compliance a company priority)

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9
Q

MED DEV: What are the 4 elements of Quality System Documentation?

A
  1. Quality Manual
  2. Policies / SOP’s
  3. Work Instructions / Process Documents
  4. Quality System Records (forms, templates, evidence of compliance)
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10
Q

MED DEV: What is change control?

A

Change control ensures that any revisions to QMS-related documents is reviewed and approved prior to implementation

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11
Q

MED DEV: What is design control?

A

Design Control: Required activities for medical device design and development - how the FDA expects manufacturers to implement the QbD principle during the design phase of a product

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12
Q

MED DEV: Where are design control activities documented and recorded?

A

In the DHF: Design History File

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13
Q

MED DEV: What class of products does design control apply to?

A

Design control regulations typically apply to all Class II and III devices. Most Class I devices are exempt, although there are some exceptions

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14
Q

MED DEV: What are the main elements of design control?

A
  1. Design and development plan
  2. Design inputs
  3. Design outputs
  4. Verification
  5. Validation
  6. Design transfer
  7. Design change
  8. Design review
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15
Q

MED DEV: What is a design and development plan?

A

Design and development plan:

  • Must be established for each product
  • Specifies the development process, compliance with design control, and assigns responsibility for each activity
  • A living document that should be maintained throughout the design process
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16
Q

MED DEV: What are design inputs?

A

Design Inputs:

  • device requirements that encompass end-user/patient wants and needs, regulatory requirements, PMS feedback, etc.
  • includes specific performance characteristics, device specifications, handling/storage requirements, clinical constraints, reliability requirements, etc. (All requirements that the device must meet)
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17
Q

MED DEV: What are design outputs?

A

Design outputs:

  • device characteristics that manifest the design inputs confirming that the device requirements/specifications are met
  • Must be measurable through verification/validation
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18
Q

MED DEV: What is design verification?

A

Design verification:
- the process of determining whether the design outputs match the design inputs for detailed requirements related to the finished device

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19
Q

MED DEV: What is design validation?

A

Design validation:

- the process of determining whether the device meets its intended use and function

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20
Q

MED DEV: What is design transfer?

A

Design transfer:
- the process by which final device specifications are transferred to manufacturing, and documented in the DMR (Device Master Record)

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21
Q

MED DEV: What are design changes?

A

Design changes:

  • changes to product
  • Design changes after a product launch must be managed/controlled to determine how the change impacts the finished device
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22
Q

MED DEV: What is a design review?

A

Design review:

  • pre-planned and documented design reviews must occur at regular intervals during D&D
  • should include 1 individual not responsible for the project
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23
Q

MED DEV: What is included in the DMR?

A

DMR: Device Master Record

- production, testing, labeling, packaging, and other product realization activities

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24
Q

MED DEV: What does IQ/OQ/PQ stand for?

A

IQ/OQ/PQ
IQ: Installation Qualification
OQ: Operational Qualification
PQ: Process Qualification

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25
Q

MED DEV: What is an IQ?

A

IQ: Installation Qualification

- each piece of equipment must be qualified and calibrated when it’s installed

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26
Q

MED DEV: What is an OQ?

A

OQ: Operational Qualification

- verify the ability of the equipment to perform its designated function(s)

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27
Q

MED DEV: What is a PQ?

A

PQ: Process Qualification

- Validate the manufacturing process related to equipment performance

28
Q

MED DEV: True/False: Equipment software also must be validated

A

TRUE! SOFTWARE VALIDATION WOOHOO!

29
Q

MED DEV: What is included in the DHR?

A

DHR: Device History Record
- all activities related to production, testing, and inspection are documented, including serial number and other device info
(aka a traveler)

30
Q

MED DEV: What does the QSR say about labeling and packaging?

A
  • Labeling must be controlled
  • Labeling must include info on manufacturer, product description, UDI, lot or S/N, expiration date, etc.
  • Packaging/shipping containers must be able to protect the device during storage/transport
31
Q

MED DEV: What does the QSR say about resource management?

A

Resources, needs, and company requirements must be identified and managed appropriately

32
Q

MED DEV: What is CA and PA?

A

CA: Corrective Action - initiates a process to address a nonconformity that has occurred to prevent the failure from happening again
PA: Preventive Action - initiates a process to address a trend or potential issue to prevent the failure from occurring

33
Q

MED DEV: What does the QSR say about complaint handling?

A
  • device manufacturers are required to establish procedures on handling product complaints
  • each complaint must be reviewed to determine whether it must be reported to the FDA
34
Q

MED DEV: What is the regulation for adverse events?

A

21 CFR 803: Medical Device Reporting (MDR)

35
Q

MED DEV: Per the QSR, how long must quality system documents be maintained?

A

Must be maintained for a period of time equivalent to the device’s expected life, but no less than two years

36
Q

MED DEV: What is a DHF?

A

DHF: Design History File

- includes documents detailing a specific device’s entire design and development process

37
Q

MED DEV: True/False: A device designed prior to QSR implementation (before 1997) does not need a DHF.

A

FALSE: A retrospective DHF should be in place to document, to the best of the manufacturer’s ability, each device’s design and development history

38
Q

MED DEV: What is a DMR?

A

DMR: Device Master Record

- contains all the necessary info to manufacture a particular device (aka the “recipe”)

39
Q

MED DEV: What is the DHR?

A

DHR: Device History Record (aka lot or batch record)

  • a record of a specific device or device lot’s production history
  • must contain UDI info
40
Q

What is the ~de facto~ standard for regulatory MED DEV: compliance that would be interpreted as meeting cGMP requirements?

A

ISO 13485:2016: Medical Devices - Quality Management Systems - Requirements for regulatory purposes

41
Q

DRUG: What is the cGMP regulation for pharmaceuticals?

A

21 CFR 210: Current Good Manufacturing Practice in Manufacturing Processing, packing, or Holding of Drugs
21 CFR 211: Current Good Manufacturing Practice for Finished Pharmaceuticals
21 CFR 212: Current Good Manufacturing Practice for Positron Emission Tomography Drugs

42
Q

What is a drug product?

A

Drug Product:
- a finished dosage form (i.e. tablet, capsule, solution, etc.) that generally contains an active drug ingredient (although not necessarily) in association with inactive ingredients

43
Q

What is a (drug) component?

A

Component:

- any ingredient intended for use in drug product manufacture

44
Q

What is an active ingredient (AI)?

A

Active Ingredient (AI):

  • any component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body
  • includes components that may undergo chemical change in the drug product’s production and be present in the drug product in a modified form intended to furnish the specified activity or effect
45
Q

What is an inactive ingredient?

A

Inactive ingredient:

- any drug product component that is not the active ingredient

46
Q

What is a batch?

A

Batch:
- a specific quantity of a drug or other material intended to have uniform character and quality, within specified limits, and produced according to a single manufacturing order during the same manufacturing cycle

47
Q

What is a lot?

A

Lot:

- A batch, or a specified identified portion, having uniform character and quality within specified limits

48
Q

What is a lot, control, or batch number?

A

Lot, control, or batch number:
- Any distinctive combination of letters, numbers, or symbols, from which a drug product batch or lot or other material’s complete manufacture, processing, packing, holding, and distribution history can be determined

49
Q

What is (drug) strength?

A

Strength:

- the drug substance’s concentration and/or the drug product’s potency as indicated by appropriate lab tests

50
Q

What is acceptance criteria?

A

Acceptance criteria:
- the product specifications and acceptance or rejection criteria, such as acceptable quality level, along with an associated sampling plan

51
Q

DRUG: What is QA?

A

QA: Quality Assurance

  • the group responsible for overseeing the administration and adherence to CGMPs
  • responsibilities: documents, internal audits, self-inspections, validations, maintenance, batch record reviews, supplier audits, complaint investigations
52
Q

DRUG: What is QC?

A

QC: Quality Control
- the group responsible for approving/rejecting all components, including drug products, containers, in-process materials, packaging/labeling

53
Q

DRUG: What are some considerations that need to be controlled for facilities and equipment?

A
  • Buildings/facilities
  • adequate space / lighting
  • adequate cleaning
  • defined areas for different activities / functions
  • adequate equipment that’s cleaned and maintained
  • water (drinking, bulk, sterile)
  • adequate air ventilation, air filtration, exhaust systems, etc.
  • proper sanitation and cleaning
54
Q

DRUGS: What are the types of controls required for drug production?

A
  • drug components and drug product containers
  • production process
  • packaging and labeling
  • laboratory testing
  • method validation
  • stability testing
55
Q

DRUGS: What types of records are required?

A
  • Master production and control records (to ensure batch-to-catch uniformity)
  • Batch records (complete info relating to a batch’s production/control)
  • Distribution records
  • Complaint files - reviewed by the QC unit and investigated as necessary
56
Q

DRUGS: How long should records be retained?

A

For at least 1 year after the batch expiration date, or for OTC drugs without an expiration date: 3 years after batch distribution

57
Q

DRUGS: What does IUO stand for?

A

IUO: Investigational Use Only

58
Q

DRUGS: What does CMC stand for?

A

CMC: chemistry, manufacturing and controls

59
Q

BIOLOGICS: What is the definition of a biological product?

A

Biological product:
- a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings

60
Q

BIOLOGICS: What additional CGMP requirements apply to biologics?

A
  • additional personnel cleanliness/safety requirements
  • plant / facility requirements
  • laboratory and bleeding rooms
  • animal quarters and stables
  • spore-forming microorganisms
  • live vaccine processing
61
Q

What is the definition of blood?

A

Blood: a fluid containing dissolved and suspended elements collected from a human’s vascular system

62
Q

What is the definition of a blood component?

A

Blood component: a product containing a part of human blood separated by physical or mechanical means

63
Q

What additional CGMP requirements apply to blood / blood components?

A
  • Personnel, facility, equipment, supplies and reagents,
64
Q

What is a combination product?

A

Combination products:

Therapeutic and diagnostic products that combine drugs, devices, and/or biological products

65
Q

What is the FDA’s Final Rule on CGMP requirements for combination products?

A

21 CFR Part 4: REGULATION OF COMBINATION PRODUCTS

66
Q

How do CGMP’s apply to combination products?

A

CGMP requirements must be applied to the constituent parts, regardless of the final combination product
Option 1: Demonstrate full compliance for drug CGMP and device QSR
Option 2: “streamlined approach” - demonstrate compliance for the applicable parts of the drug CGMP and device QSR

US Medical Device Regulations (11 decks)

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