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PR3145 > Lecture 6 GMP Topics in Industry 4.0 > Flashcards

Lecture 6 GMP Topics in Industry 4.0 Flashcards

1
Q

What are the Pharmaceutical Inspection Trends in industry 4.0?

A
  1. Regulating/Inspecting Products derived from Newer Technologies
  2. Migrating from QbT to QbD via PAT
  3. Continuous Manufacturing
  4. Managing API, Excipient Quality and Supply Chain Integrity
  5. Single Use Technologies (SUT)
  6. Data Integrity Assurance and Fighting Falsified Medicines
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2
Q

What are GMP and Safety Concerns relating to Nanoparticles?

A

• Free Nanoparticles Released into the Environment during Manufacture are a Potential Health and Cross Contamination Hazard
- A clear and globally acceptable regulatory framework is needed to facilitate development and public acceptance of nanomedicines

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3
Q

What are some limitations of conventional QC testing?

A
  • representative sample size
  • -> conventional QC tests are destructive
  • -> poor quality unit not picked up due to statistical limits
  • The Defects are picked up only at the end of manufacturing process and cannot be rectified/reworked
  • QC test not conducted/released in real time (expensive cost of storage space during quarantine of bulky products e.g. LVP)
  • can test only if you know the analyte & you have a test method
  • test method is specific, accurate, reliable
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4
Q

What does PAT stand for?

A

Process Analytical Technology

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5
Q

What are the benefits of QbD/PAT?

A
  • Non-destructive
  • Deeper process understanding, better control and higher quality assurance (due to ability to scan/image entire batch of material/product)
  • Real time release (soon after manufacture)
  • Cost savings
  • Reduction in post-approval submissions (not in notes)
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6
Q

What are the challenges of QbD/PAT implementation?

A
  • Limited understanding
  • High financial investment in PAT (initial capital outlay and long term savings)
  • Old Habits Die Hard: Industry accustomed to not reviewing a validated process based on QbT.
    fear that PAT/QbD tools may reveal inadequacies of product, and may cause voluntary recalls
  • Regulators not ready for QbD/PAT submissions: Regulators used to old paradigm QbT
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7
Q

What is/are the advantage(s) of continuous manufacturing?

A
  • Higher QA through At-line testing using non-destructive PAT/Other tech
  • Real-Time Release of finished product (save warehouse space)
  • Shorter Batch processing time (Days) - increase efficiency -cost saving
  • Integrated Processes - fewer steps (less manual handling and contamination)
  • Smaller equipment and facilities (more flexible operation, reduced inventory, lower capital cost)
  • on-line monitoring: higher level QA, real time release, more consistent quality

(overall cost reduction!)

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8
Q

What is/are the regulatory hurdle(s) for continuous manufacturing?

A

There are no regulatory hurdles

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9
Q

What is limiting the implementation of continuous manufacturing?

A
  • manufacturers need to understand integration amongst unit operations and manage continuous manufacturing data from all at line measurement systems e.g. PAT and other tech
  • Regulators/Inspectors need to have deeper understanding on how to implement/facilitate/support continuous manufacturing which is science and risk based
  • Experience is still lacking from manufacturers and regulators
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10
Q

Where are the bulk of APIs produced globally?

A

Asia, especially China and India (neither of which are PICS members)

EU and US import ~80% of APIs from china and india

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11
Q

What is the effect of increased number of players in API/product supply chain?

A
  1. Many potential points for interference of API/Product

2. Falsified medicines

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12
Q

How can GMP/GDP compliance and vigilance help assure API supply chain Integrity?

A
  • Assure quality
  • Deter manipulation
  • Detect adulterated products, counterfeits and falsified medicines
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13
Q

Are excipients regarded as inactive or inert ingredients?

A

No

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14
Q

What is driving the growth of Single Use Technologies (SUT) ? (not tested)

A
  • Enhanced levels of containment and cross contamination control
  • More flexible manufacturing
  • Requires less space
  • Multiple applications in biotechnology manufacturing industry
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15
Q

What are the test considerations of SUTs? (not tested)

A
  • Material compatibility (chemical resistance)
  • Extractables
  • Biocompatibility
  • Animal origins
  • Particulate control
  • Bioburden/endotoxins
  • Adsorption
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16
Q

What is the ASTM D543-06 standard testing for? (not tested)

A

Material compatibility

- ASTM (American standard for testing materials)

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17
Q

What are some reference standards and guides for SUT testing? (not tested)

A

US/EU: ISO, ASTM, USP, EMA
International: ISPE, PDA, BPSA, BPOG
- slide 29

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18
Q

When was the ASEAN sectoral MRA on GMP inspection signed?

MRA: mutual recognition agreement

A

Signed by Economic Ministers of all 10 ASEAN Member States on 10 April 2009, Pattaya, THAILAND

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19
Q

What products does the ASEAN sectoral MRA cover?

MRA: mutual recognition agreement

A

Covers Medicinal Products in Finished Dosage Forms
- both prescription and OTC pdts

(does not cover biopharm pdts & APIs)

20
Q

Which regulatory framework forms the basis of the ASEAN sectoral MRA?

A

PICS framework

21
Q

Who implements the ASEAN sectoral MRA?

A

ASEAN Joint Sectoral Committee (JSC)

22
Q

What are Listed Inspection Services (LIS)?

A
  • Inspectorates or regulatory agencies which meet the PICS inspection framework
  • Either the regulatory agency is a member of PICS or an ASEAN panel of experts (POE) has been formed to assess the particular regulatory authority in ASEAN and determined it is operating a PICS inspection framework
23
Q

What are some benefits of the ASEAN MRA on GMP inspection?

A

(1) Avoiding duplication of pharmaceutical inspections within ASEAN
(2) Saving time, resources and costs for regulators and manufacturers

(3) Facilitating Trade in Medicinal Products across ASEAN
(4) Quicker Access of Medicinal Products by ASEAN Patients

(5) Harmonizing ASEAN Inspection System to that of PIC/S
(6) Increased Attractiveness of ASEAN to investors from Asia and rest of the world

24
Q

Who are the current members of the Listed Inspection Services (LIS)?

A

Singapore HSA (PIC/S member since 1 Jan 2000)

Malaysia NPRA (PIC/S member since 1 Jan 2002)

Indonesia NADFC (PIC/S member since 1 Jul 2012)

Thailand FDA (PIC/S member since 1 Aug 2016)

Philippines FDA (not a PIC/S member)

25
Q

What are some key components of the Audit checklist for ASEAN PoE?

A
  • Legislative, Regulatory Requirements and scope
  • Regulatory directives and policies
  • GMP standards
  • Inspection resources, procedures and performance standard
  • Analytical capability
  • Quality Management System (QMS)
26
Q

What is the scope of the ASEAN sectoral MRA expanding to include?

A
  • Manufacture of APIs

- Manufacture of Biologicals/ Biopharmaceuticals

27
Q

What are some soft skills that are useful for the industry?

A
  1. Be a Paranoid Optimist
  2. Think of Yourself as a Software
  3. Think like an Immigrant
  4. Think like an Artist
  5. Be a Life long Learner
28
Q

what is on-site inspection vs remote inspection?

A

on-site inspection: inspectors physically present

remote inspection

  • e-technology
  • e.g. desktop inspection: a remote inspection based on review of documentary evidence by the company; ‘paper-based’ remote inspection
29
Q

what are diff types of inspection?

A

on-site
remote
hybrid

30
Q

what are the arrangements for remote inspection

A
  • virtual inspection platform (zoom)
  • internet, audio-visual resolution
  • parties involved & their roles
  • time and duration, time zones
  • file sharing platforms to be confidential, secure and accessible
  • safety: use of handphones/video camera –> potential cross-contamination
  • document system e.g. scanners, printers, technical support staff on standby
31
Q

challenges of remote inspection

A
  • limitation of e-tech (e.g. unstable connection, poor audio-visual)
  • limited resources at M site (due to split team)
  • slow response time to complete remote inspection
  • lack of body language
  • difficult to inspect utilities and manufacturing operation (whether ‘live’ or ‘pre-recorded’)
32
Q

how do we make sure remote inspection can be better

A

use of mutual reliance programme (esp for overseas manufacturer; and overseas inspection

33
Q

benefits of PIC/S Membership

A
  • reduce duplication of GMP inspection

- increase opportunity for collaboration

34
Q

why was the PIC/S GMP Inspection Reliance published?

A

due to the complexity of global supply chains, where the demands for inspections far exceed what an inspectorate can accomplish alone

35
Q

what does the PIC/S GMP Inspection Reliance encompass?

A
  • having a mutual recognition agreement (MRA) on GMP inspection
  • GMP Compliance status of the PIC/S Participating Authority
  • recognition of inspection outcome by a hosting inspectorate
36
Q

What does the WHO Good Reliance Practices encompass?

A
  • covers reliance activities in the regulation of medical products
  • inspects the entire product life cycle
  • -> market authorisation
  • -> GMP inspections
  • -> clinical trials
  • -> lab testing
  • -> lot release
  • guideline for all national regulatory authorities
  • WHO recommends various approaches to reliance
37
Q

does reliance on the assessment performed by another National Regulatory Authorities (NRA) mean that the regulation is less stringent?

A

No, mutual reliance is the hallmark of modern and efficient regulatory authority and smart regulation

38
Q

GMP compliance and process control can affect ___________

A

quality of APIs (e.g. particle size) and affect purity

e. g. if particles produced are too big, reduce solubility and efficacy - drug resistance (Rifampicin) in TB treatment
e. g. Undesirable isomer of Thalidomide caused phocomelia (there was lack of compliance)

39
Q

What are some spin-offs from Singapore’s PIC/S membership?

A

SG-Australia MRA on GMP inspection in 2001
Legal recognition of Singapore’s Pharmaceutical Inspection System by Australia and vice versa

Work-sharing program - NZ Medsafe, Health Canada, Swissmedic, Singapore HSA

40
Q

What are the further spin-offs for ‘work sharing’ program?

A
  • Australia-Canada-Switzerland-SG (ACSS) Consortium in 2007
  • Australia-Canada-UK-Switzerland-SG (Access) Consortium on 2021
  • SG-New Zealand MRA on GMP inspection in 2020
41
Q

why mra is better than MRA?

A

MRA (mutual recognition agreement)
mra (mutual reliance approach)

  • MRA relatively takes a longer time to negotiate/conclude.
  • Often, MRAs are negotiated under larger platform of Free Trade Agreements (FTAs)
  • MRA negotiations involve regulators, lawyers/AGC, trade and industry representatives, etc.
  • Considerations are given to Pharmaceutical Import/Export Volumes, and other impacts

thus, mra will be a good 1st step forward

42
Q

The definition of a batch is different for batch and continuous manufacturing. True or False

A

False, definition of batch is the same

Batch - specific quantity of product with uniform quality regardless of mode of manufacture

43
Q

What is API reponsible for in a drug product?

A

API - therapeutic effect of drug product

without API, product is basically a placebo

44
Q

What are the disadvantages of traditional batch manufacturing of products?

A
  • intermediate products collected after each unit operation
  • finished product collected at end of batch manufacturing
  • QC tests performed at off-line laboratories and finished products quarantined at warehouse

Total Batch Processing time - WEEKS –> inc cost

45
Q

what are the benefits of remote inspections and reliance in this century?

A

under takeaway message:

  • remote inspection have enabled business continuity during covid-19
  • decrease travel time for cosmetic & overseas inspection
  • accord flexibilities regarding time frame and inspection pace
  • during pandemic, remote inspections & reliance are the ONLY 2 options available for overseas manufacturing

(most national laws have on-site, remote, or hybrid inspection or use of reliance for M making pharmaceuticals, biopharms, finished pdts and API)

PR3145 (10 decks)

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