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a PR3145 > LEC 6 > Flashcards

LEC 6 Flashcards

1
Q

Onsite inspection

A
  • inspectors are physically present at manufacturing site
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2
Q

Remote inspection

A
  • mimics onsite inspection in terms of format, time-frame & overall rigor
  • desktop inspection is a type of remote inspection
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3
Q

Desktop inspection

A
  • a form of remote inspection based on review of documentary evidence
  • paper-based remote inspection
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4
Q

Challenges of remote inspection (4)

A
  1. poor internet connectivity
  2. limited resources at manufacturing sites due to split teams
  3. overall slower response time to complete remote inspection
  4. difficult to inspect utilities and manufacturing operations

Hence, now adopt hybrid inspection + mutual reliance program

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5
Q

Benefits of ASEAN MRA on GMP inspection (6)

A
  1. avoid duplication of inspection within ASEAN
  2. save time, resources and costs for manufacturers and regulators
  3. facilitate trade in medicinal products across ASEAN
  4. quicker access of medicinal products by ASEAN patients
  5. harmonisation of ASEAN inspection system to that of PIC/S
  6. increase attractiveness of ASEAN to regulators & investors
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6
Q

MRA

A

Mutual Recognition Agreement

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7
Q

MRA vs mra

A

MRA

  • Mutual Recognition Agreement
  • legally binding
  • can take relatively long time to negotiate and conclude

mra

  • mutual reliance approach
  • not legally binding
  • only involve regulators and inspectors only
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8
Q

Framework for PIC/S GMP inspection reliance (3)

A
  1. have MRA on GMP inspection
  2. recognition of GMP compliance status by a facility within the territory of PIC/S participating authority
  3. recognition of inspection outcome by a hosting inspectorate which has been assessed under a robust framework
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9
Q

NRA reliance by WHO Good Reliance Practices

A
  • an act whereby an NRA takes into account an assessment performed by another NRA (or a trusted institution) in reaching its own decision
  • the relying NRA remains independent, responsible and accountable for his decision
  • doesnt mean less stringent regulation
  • mutual reliance is a hallmark of a modern and efficient regulatory authority and smart regulation
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10
Q

Limitations of conventional product testing (3)

A
  1. req “representative” sample
  2. can only test if you know the analyte and have a test method
  3. test method must be accurate, reliable and specific (validated)
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11
Q

Advantages of QbD/PAT (4)

A
  1. non-destructive
  2. deeper process understanding, better control and higher QA
  3. real time release of product
  4. cost saving
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12
Q

Challenges of QbD/PAT (4)

A
  1. limited understanding of QbD/PAT
  2. high financial investment in PAT
  3. old habits
  4. not ready for QbD/PAT submissions
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13
Q

Disadvantages of traditional manufacturing (4)

A
  1. need to collect intermediate product for testing
  2. need to collect end-product for testing
  3. need to quarantine products in the meantime of testing (cost of storage space)
  4. increased total batch processing time (costly)
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14
Q

Advantages of continuous manufacturing (4)

A
  1. fewer steps, fewer contamination
  2. shorter batch processing time
  3. smaller equipment and facilities
  4. online monitoring and QC (higher quality and real time release)
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15
Q

mra

A

mutual reliance approach

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16
Q

PIC/S GMP Inspection Reliance

A
  • with “complexity of global supply chains”, demands for inspections far exceed what any one inspectorate can accomplish alone
  • hence, PIC/S published a guidance on GMP Inspection Reliance on 1 June 2018
17
Q

Advantages of Post-Covid increasing trend towards (2) :

  • remote inspection
  • reliance (MRA/mra)
A
  • decrease travel times (both domestic and local)

- accord flexibilities to inspectors and inspectees regarding timeframes and inspection pace

18
Q

Impact of 5 LIS on ASEAN MRA

A
  • can now expand the scope of MRA to include API and biopharmaceuticals
19
Q

5 LIS (ASEAN)

A
  1. Singapore
  2. Malaysia
  3. Indonesia
  4. Thailand
  5. Philippines
20
Q

Nanotechnology and Nanomedicines

A
  • nanoparticles can interact with biomolecules to treat pathologic problems even before the expression of the disease symptoms
21
Q

Advantages of Nanomedicines (3)

A
  1. Effective in targeting difficult-to-reach site (tumors)
  2. Improved solubility, bioavailability and reduced side effects
  3. Achievement of same therapeutic effect with smaller doses
22
Q

Disadvantage of Nanomedicines

A
  • shown to accumulate in organs
  • haemolyze erythrocytes
  • safety concerns

Hence, a clear, globally acceptable framework is needed to facilitate the development and public acceptance of nanomedicines

23
Q

QbT

A
  • Product/batch tested only at the end of manufacturing process
  • If product passes the test, it was deemed to be of good quality
24
Q

Batch definition

A

Refers to a specific quantity of product with uniform quality regardless of mode of manufacture

25
Q

Advantage of GMP/GDP compliance and vigilance in the industry

A
  1. Assure quality of API/pharmaceutical products
  2. Detect manipulation by unscrupulous supply chain players
  3. Detect adulterated products, counterfeit and falsified medicines

a PR3145 (14 decks)

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