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Medical Device Manufacturing Practice > Online Test 2 > Flashcards

Online Test 2 Flashcards

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USMLE® Step 1 flashcards
1
Q

Post Market surveillance relation to QMS

A

Post Market Surveillance is a subset of quality management system

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2
Q

Post Market Period

A

User starts using to end-of-life disposal

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3
Q

After-sales obligations

A
  • Record keeping of supply
  • Monitoring device’s clinical performance
  • Identifying and correction action of any problems
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4
Q

Effective post market surveillance

A

monitors performance of device under actual usage conditions to ensure public and patient safety

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5
Q

Why is post market control important

A

ongoing safety and performance monitoring is important to ensure patient and public safety after device is released on the market

  1. inherent risk throughout the medical device life cycle, even for low risks ones,
  2. limitation of pre-market registration controls, and to
  3. enable timely intervention to safeguard public health.
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6
Q

Responsibility of product risk management

A

lies in management

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7
Q

What is post market surveillance

A

system providing continuous feedback about a device on the market to maintain high standard of product safety and quality
feedback is gathered via collection of processes and activities used to monitor the performance of a medical device after being released on the market

regulatory requirement in EU and ASEAN

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8
Q

Proactive activities

A
  • Customer surveys
  • Post approval clinical studies
  • Expert user focus groups
  • Implant registries
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9
Q

Reactive activities

A
  • Customer complains
  • Maintenance service reports
  • Detection of manufacturing issues
  • Vigilance (EA & FSCA)
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10
Q

Post-market alert system requirements

A
  • Distribution records
  • Complaint records
  • Adverse events (AE) reporting criteria and reporting format
  • Field safety corrective action (FSCA) reporting format
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11
Q

Definition of adverse events

A

By GHTF: malfunction or deterioration in characteristics or performance of a supplied medical device or use error, which has, or could have caused/ contributed to death/ injury of the patient or others

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12
Q

objective of AE reporting and subsequent evaluations

A

improve protection of the health and safety of patients, users and others by disseminating information to reduce the likelihood of/ prevent repetition of AEs, or alleviate consequences of such repetition

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13
Q

AE of IVD

A

consequence of a medical decision/ action taken/ not taken, on the basis of result(s) provided by the IVD medical device

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14
Q

FSCA includes

A
  1. return of a medical device to the product owner or its representative which is recall
  2. Modification – which will be elaborated in the next slide
  3. Device exchange
  4. Destruct – it could be disposed at user’s end, product owner not collecting it back
  5. Advice given by product owner regarding the use of the device
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15
Q

FSCA device modification may include

A
  1. Retrofit in accordance with the product owner’s modification or design change
  2. Permanent or temporary changes to the labelling or instructions for use
  3. Software upgrades including those carried out by remote access
  4. Modification to the clinical management of patients to address a risk of serious injury ordeath related specifically to the characteristics of the device
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16
Q

Why is FSCA important

A

required when manufacturer of the medical device has to take action (including recall of the device) to eliminate/ reduce the risk of identified hazards

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17
Q

Product recall

A

action taken by product owner to remove / retrieve the health product from the market

Product may be:

  • hazardous to health
  • unable to conform to any claim made by its product owner relating to its quality, safety or efficacy
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18
Q

Who can initiate FSCA

A
  • Product Owner

- Regulatory Agency

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19
Q

HSA regulation

A

Health Product Act (HPA): regulate manufacture, import, supply, presentation and advertisement of all health products

Health Products (Medical Devices) Regulations 2010: covers control of medical devices only

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20
Q

Medical Device Regulatory Framework

A

Legal Framework:

  • Premarket registration
  • Post-market
  • Medical device establishment
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21
Q

Pre-market registration

A
  • Medical device definition
  • Medical device classification
  • Medical device registration Z(Class A exempted)
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22
Q

Post-market

A
  • Adverse events (AE) report criteria

- Field safety corrective action (FSCA) monitoring

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23
Q

Medical device establishments

A
  • Establishment license (for manufacturer, importer & wholesaler)
  • QMS certification
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24
Q

Regulatory control points to regulate medical devices

A
  1. Licensing of manufacture, import & supply
  2. Product registration (on Singapore Medical Devices Register SMDR, Class A exempted)
  3. Post-market records of recalls, distribution & advertisements
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25
Q

Types of registration in conformity assessment

A
  • Registration of devices

- Registration of persons

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26
Q

Mandatory requirements in Health Products Act

A
  • Control supply chain via dealers & establishments
    Dealer Licensing
  • Legislation identify and define the joint responsibility of importers, authorised representatives and distributors
  • All of them are governed by the legislation and must comply
  • Responsibility period is for the entire lifetime of the device
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27
Q

Premarket control of medical device regulation (2 prong)

A

Dealer Licensing

  • Manufacturer’s License
  • Importer’s License
  • Wholesaler’s License

Product Registration
- Registered medical device for supply in

28
Q

Dealer’s Control

A

GDPMDS SS620:2016 is a requirement for all licensed local importers and wholesalers (auditable)
* ISO13485 for Manufacturers already covers the scope for GDPMDS

29
Q

Good Distribution Practice for Medical Devices

A
  • mandatory to importers & wholesaler
  • ensures quality distribution system
  • ensure a system to comply with post-market requirements, including AE reporting and FSCA
30
Q

Distributor Activities

A

procurement, storage, distribution of medical devices in large quantities in accordance with legislation

31
Q

Product Registration

A
  • Phased in approach
  • Higher risk C & D registered before A & B
  • Authorised Representative (AR) responsible (does not need GDPMDS and are not top management)
32
Q

How to register product

A

Singapore uses the CSDT – common submission dossier template for submission

33
Q

Pharmaceutical Manufacturing

A
  • Milling
  • Drying
  • Compresison
  • Coating
34
Q

Drug features

A
  • Consists of therapeutics and excipients combined in a delivery system
  • deliver drugs at certain rate determines drug success
  • Active Pharmaceutical Ingredients (API): active ingredients in medicine
35
Q

Good Manufacturing Processes (GMP) of drugs

A
  • record keeping
  • personnel qualifications
  • sanitation
  • cleanliness
  • equipment verification
  • process validation
  • complaint handling
36
Q

Sources of risks from drug products

A
  • Avoidable & unavoidable known side effects
  • Medication errors
  • Product quality defects
37
Q

Product/ Process development paradigm

A
  • Manufacturing
  • Process development & scale up
  • Formulation
  • Drug synthesis
38
Q

Dosage Forms

A
  • Tablet/ Capsules
  • Injectables
  • Inhalants
  • Transdermal implants and products
39
Q

Oral dosage forms

A

Tablets

  • Lozenges
  • Chewable tablets
  • Effervescent tablets
  • Multi-layer tablets
  • Modified release

Capsule

  • Hard gelatin
  • Soft gelatin

Powder

40
Q

Inhaled dosage forms

A

Aerosols

  • Metered-dose inhalers
  • Dry powder inhalers
41
Q

Stages of pharmaceutical manufacturing

A
  1. Starting materials (chemicals)
  2. API
  3. Finished product (includes exepients)
  4. Primary packaging
  5. Secondary packaging
42
Q

What are excipients

A
  • an inert substance added to the drug to give suitable consistency or definite form to the drug
  • pharmaceutical necessity/ aid
43
Q

Types of excipients

A
  • Antioxidants
  • Ointment base

*for compounding of the pharmaceutical dosage forms

44
Q

Antioxidant

A
  • inhibits oxidation
  • added to prevent deterioration via oxidation
    etc.
  • the development of rancidity in oils and fats
  • inactivation of some medicinal in the environment of their dosage form

Provides H+ electron to free radical to terminate chain reaction

45
Q

Excipient list

A

Fillers:
increases weight and size of final dosage form

Binders:
promote particle aggregation

Disintegrants:
promote breakdown of aggregates

Flow aids:
reduce interaction between particles

Lubricants:
reduces interaction between particles and surfaces of processing equipment

Surfactants:
promotes wetting

Modified release agents:
influences the release of active

46
Q

Solid Dosage Processing

A

Dosage forms
- Quality factors

Excipients
Particle properties
Processing routes
Unit operations

47
Q

Quality factors for solid dosage forms

A

Functional quality factors

  • Disintegrates to desired size quickly
  • Dissolve and absorbed in the GI tract at a pre-determined rate

Physical quality factors

  • withstand processing, packaging, transportation, dispensing or handling
  • Surface must be free of defects
  • Must be stable under anticipated environmental conditions
  • consistent weight & composition for each pill

Sensorial quality factors
- Easy and pleasant to swallow

48
Q

Product Functions

A 
Product property
• Content uniformity
• Dissolution
• Flow-ability
• Dust formation

Particle Properties
• Particle size
• Particle shape
• Surface characteristics

49
Q

Processing Routes

A
  1. Wet granulation
  2. Dry granulation
  3. Direct compression
50
Q

Unit Operations

A

Process function
– Process parameters: Type of unit operation, operational parameters

Type of unit operation
Size reduction (Milling)
– Blending
– Dry granulation (Roll compaction)
– Wet granulation
– Drying
– Tablet compression
– Coating
51
Q

Who discovers drugs?

A

Identify biological target - biology
Prioritise/ validate target – pharmacology and chemistry
Identify and optimise lead molecules – chemistry/pharmacology
Preclinical studies – chemistry/pharmacology/ toxicology
Formulation - pharmaceutical sciences
Clinical evaluation – medicine
Manufacture - chemical engineering

52
Q

Good Laboratory Practices (GLP)

A

quality system concerned with the organisational process & conditions under which nonclinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported

53
Q

Objectives of GLP

A
  • True reflection
  • Ensure Honesty
  • International acceptance
54
Q

Scope of GLP (OECD)

A 
applies to all non-clinical health and environmental safety studies required by regulations for the purpose of registering or
licensing
• Pharmaceuticals
• Pesticides
• Food and feed additives
• Cosmetic products
• Veterinary drug products and similar products
• Industrial chemicals
55
Q

Organisation and Personnel

A
  • Management’s Responsibilities
  • Ensure sufficient number of qualified personnel, appropriate facilities, equipment, and materials
  • Ensure the maintenance of a record of the qualifications, training, experience
  • Proper training of personnel to assigned functions
  • Job description for each professional and technical
  • To establish and follow SOP
  • Quality assurance program with designated personnel
56
Q

Organisation and Personnel Study Director

A

responsible for the overall conduct of the non-clinical health and environmental safety

  • Approval of protocols & the study plan including amendments
  • Ensure QA personnel and study personnel are updated with study plans & SOP
  • Ensure the follow up of SOPs periodically and take appropriate corrective action
  • Archiving Raw data, supporting materials and final report
57
Q

Organisation and Personnel Principal Investigator

A

• Ensures the study is conducted in accordance with GLP

58
Q

Organisation and Personnel Study Personnel

A
  • Recording of all raw data in compliance with the principles of GLP
  • Deviations from the instructions to be reported the PI or SD
  • Takes health precautions and personal safety
59
Q

Quality Assurance Program

A

individual or a group designated by management to assure studies comply with GLP Principles

• Maintains copies of protocols & SOPs
• Inspects each laboratory and man at work
– Study-based inspections
– Facility-based inspections
– Process-based inspections
• Determines any deviation from approved protocol and report to SD, PI & management
• Prepare statements to be included in final report containing dates & types of inspection

60
Q

Facilities

A

Test System Facilities

Archive Facilities

Waste Disposal

61
Q

Test System Facility

A
  • Sufficient amount of rooms and areas to assure isolation of test systems
  • Adequately protected storage area separate from test systems
  • Areas available for the diagnosis, treatment and control of diseases
62
Q

Archive Facilities

A

• Secure storage and retrieval of study plans, raw data, final reports & specimens to prevent untimely deterioration

63
Q

Waste Disposal

A

• Appropriate collection, storage & disposal facilities and decontamination procedures

64
Q

Apparatus, Materials & Reagents

A

Apparatus:

  • validated computerised systems should be of appropriate design & adequate capacity
  • periodically inspected, cleaned, maintained and calibrated according to standard operating procedures

Materials & Reagents:
labelled to indicate identity, Conc, DOE & storage instructions

*Should not affect adversely with the test systems

65
Q

Test Systems

A

Physical/Chemical
• appropriately designed apparatus
• Integrity of test systems to be ensured

Biological
• Proper storage, housing and handling conditions
• Isolation of newly received animals/plants for evaluation and acclimatisation
• Information regarding identity at the containers
• Records of source, date of arrival and arrival condition
• Interference & Contamination free test system

Medical Device Manufacturing Practice (4 decks)

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