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PR3145 > L1 > Flashcards

L1 Flashcards

1
Q

Slim10

A

adulterated chinese proprietary medicine

  • appears good, sleak and elegant: health risks not obvious
  • adulterated with nitro-enfluramine, caused deaths and liver toxicity in many patients (2003, SG and Asia)
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2
Q

Adulterated products

A

Slim10 (CPM), heparin injection (medicinal product)

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3
Q

Heparin injections

A

adulterated medicinal product, by baxter healthcare

  • adulteration occured at uninspected premises
  • appears good, health risks not obvious
  • adulterated with oversulphated chondroitin sulphate (OSCS), mimics chemistry and pharmacology of heparin
  • caused more than 100 deaths and hundreds of serious allergic reactions
  • 2008, US and 10 other countries
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4
Q

Counterfeit medicinal product

A

appears good and IDENTICAL, health risks not obvious

  • serious quality, health risks and patient violation issues
  • often made by backyard manufacturers
  • authentic lot: A052788
  • counterfeit lot: A041410
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5
Q

What is the difference between manufacturers of counterfeit medicinal products and contaminated medicinal products?

A

Contaminated medicinal products are made by licensed manufacturers
- a problem with manufacturers producing multiple products using multi-purpose equipment in facilities lacking cross-contamination control program

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6
Q

Falsified medicines

A

medicinal products/API with false representation

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7
Q

What are the types of information that may be falsified? (6)

A
  1. name of manufacturer
  2. name of market authorisation holder
  3. batch number
  4. packaging/labelling
  5. identity/composiition
  6. manufacturing records/certificates of analysis
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8
Q

Regulators (inspectors, reviewers and analysts)

A
  • weed out adulterated, counterfeits and contaminated products
  • ensure safe, efficacious and quality products
  • oversee drug/API manufacturing and supply chain
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9
Q

What is the pre-requisite for issuance and retention of manufacturer’s license?

A

Compliance with PIC/S GMP standard

- GMP compliance assessed through 18-36 months periodic audits by inspectors from HSA

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10
Q

Role of pharmaceutical inspector

A

Inspecting manufacturer’s compliance to PICS GMP standard

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11
Q

How many members are there in PIC/S, as of 1st Jan 2020?

A

53

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12
Q

When did Singapore join PIC/S?

A

1 jan 2000, first asian member

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13
Q

What is PIC/S goal?

A

lead the international development, implementation and maintenance of harmonised GMP standard (for manufacturers) and quality system(for inspectors) in the field of medicinal products
- include herbal, API, biological, clinical trial products

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14
Q

Where was PIC/S based in?

A

Switzerland

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15
Q

When was the latest PIC/S GMP standard revision?

A

2018

- dynamic, undergoes revision from time to time

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16
Q

When was HSA formed?

A

April 2001

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17
Q

What is GMP?

A

A quality system standard implemented by pharmaceutical manufacturers to help ensure that:

  • a medicinal product is consistently manufactured and controlled
  • to the quality appropriate for its intended use(s), and
  • as required by its market authorisation (aka product license)
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18
Q

How many chapters are there in the PIC/S GMP standard? And what are they?

A
  1. pharmaceutical quality system
  2. personnel
  3. premises and equipment
  4. documentation
  5. production, including packaging
  6. quality control
  7. outsourced activities (contract manufacture and analysis)
  8. complaints and product recall
  9. self-inspection (IQA)
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19
Q

Conventional manufacturing flow (places)

A
  1. warehouse
  2. weighing room, production areas, packaging
  3. QC laboratories: chemistry lab, microbiology lab
  4. document audit: SOP, records, reports, etc
20
Q

Which chapters in the PICS guide refer to ‘warehouse’?

A

chapter 3 (premises: storage areas), chapter 5 (production: starting materials)

21
Q

Objective of warehouse inspection

A

assess that:

  • all starting materials ie. APIs, packaging materials and finished products have approved specifications and materials are purchased from approved suppliers
  • procedures (SOP) are in place for handling receipt, quarantine, sampling (including availability of sampling room), release of materials and for handling rejected materials and products
  • environment of warehouse eg temp and RH monitoring and pest control programs, preserves quality of materials and products stored
22
Q

Objective of weighing room inspection

A
  • calibrated, accurate and reliable weighing balances are used
  • weighed materials are of correct identity, quantity and quality
  • authorised personnel wear appropriate PPE and environment of weighing room controlled to prevent cross contamination
23
Q

Which chapters in the PICS guide refer to ‘weighing room’?

A

Chapter 5 (production: dispensing)

24
Q

What are the items covered during audit of weighing room?

A
  • calibration of weighing balances
  • labelling of starting materials
  • personnel wear proper gowns and ppe
  • SOP for weighing method (and records of weighing)
  • dust extraction system and housekeeping of weighing room
25
Q

Which chapters in the PICS guide refer to ‘production department’?

A

Chapter 5 (production: paragraphs 5.1 to 5.71)

26
Q

objectives of inspecting production department

A

assess that:

  • premises are designed to prevent corss-contamination
  • equipment are effectively cleaned and regularly maintained
  • personnel control programs are in place: restricted access only to authorised personnel, authorised personnel wear appropriate gowns and ppe
  • materials of correct identity, quantity and quality are used for production
  • process controls are in place eg. critical processes are validated/re-validated, in-process quality controls are in place, comprehensive batch processing records are kept
27
Q

items/areas covered during inspection of production department

A

Production Rooms (premises), equipment (machine), process (method), personnel (manpower)

28
Q

inspection of production department: premises

A
  • design/construction
  • partition/segregation, air-handling and containment
  • connecting pipe-work (stainless steel) and drainage (no back flow)
  • change room (appropriate class and air shower)
  • cleaning/maintenance and records
  • environmental and micrbiological monitoring
29
Q

inspection of production department: machine

A
  • design and construction
  • cleaning/maintenance, calibration and usage records
  • status labelling of equipment
30
Q

inspection of production department: method

A
  • labelling/control of weighed starting materials
  • gowning of production personnel
  • batch production records
  • process deviation and investigation
  • process validaiton, revalidation and change controls
31
Q

inspection of production department: manpower

A
  • wear appropriate ppe and do not wear cosmetics/jewelry
32
Q

inspection of packaging room: premises

A
  • design and construction
  • cleaning/maintenance and calibration
  • environmental and microbiological monitoring
33
Q

inspection of packaging room: machine

A
  • cleaning/maintenance, calibration and usage records

- status labeling of equipment

34
Q

inspection of packaging room: method

A
  • control of labels and packaging materials, bulk and finished products
  • batch packaging records
  • validation/revalidation and change controls
35
Q

inspection of packaging room: manpower

A
  • gowns and ppe of operators
36
Q

Which chapters in the PICS guide refer to ‘QC department’?

A

chapter 6 (quality control: paragraphs 6.1 to 6.41)

37
Q

objectives of inspecting qc department/labs

A

assess that:

  • properly trained analysts are available and there is independent authority for head of qc
  • qc test methods are approved by HSA and are robust, sensitive, accurate and reliable for testing as evident from records of analytical method validation and routine qc test results
  • procedures are in place for maintenance, calibration, status labeling and assuring integrity of qc test equipment, eg. hplc, gc, dissolution tester
  • procedures are in place for receipt, storage, security, record-keeping of test samples, reagents and reference standards
38
Q

areas/items covered under inspection of qc laboratories

A

chemistry testing laboratory

  • test samples (api, finished products, water, swabs, etc)
  • prepared reagents
  • reference standards (chemical): pri, sec
  • retention samples (for stability or regulatory testing)
  • test methods: types (eg ID, assay, DT), calibration of equipment, validation, raw data records and print-outs
  • failure (OOS) investigation
  • stability studies
39
Q

objectives of documentation audit (SOPs, records, reports, etc)

A

assess that:

  • legal requirements under medicines and hpa are complied by manufacturer
  • regulatory commitments to HSA are complied by manufacturer: eg. composition of finished products and specifications of starting materials, test methods used, process valisation/stabiltiy study reports-protocols and acceptance criteria
  • manufacturing SOPs, incl those on product quality reviews, handling of complaints and recalls and self-inspection, are followed
  • manufacturing records are authentic: no falsification of data

manufacturer conforms to legal and regulatory requirements and PIC/S GMP standard

40
Q

PQR

A

chapter 1: PQR should be conducted annnually on all authorised products:

  • quality of starting materials
  • quality of finished products and critical in-process controls
  • failed batches of products
  • manufacturing process/qc deviations
  • changes to manufacturing processes and analysis methods
  • changes to market authorisations (product licenses)
  • stability testing program
  • complaints and product recalls: investigations and closed out
  • adequacy of previous CAPAs carried out
  • qualification status of key equipment and utilities ef water, HVAC, steam
41
Q

complaints

A

chapter 8

  • a designated person should be responsible for handling complaints and deciding on actions to be taken
  • a written procedure (SOP) on handling complaints should be in place
  • all complaints shall be recorded, investigated and closed out with decisions taken documented
  • all complaint records should be reviewed regularly for any recurring trend
  • the Competent Authority (Regulatory Authority) should be notified if manufacturer is considering product recall following serious quality defects, faulty manufacture and evidence of counterfeit products
42
Q

recalls

A

chapter 8

  • a designated person, independent of Sales and Marketing, should be responsible for coordinating and executing recalls
  • a written procedure (SOP) should be in place for product recalls
  • distribution reocords should be readily available to the designated person
  • the Competent Authorities (Regulatory Authorities) where the product is distributed, should be notified if manufacturer is considering product recall
  • recalled product should be stored securely while awaiting decision on its fate
  • progress of recall process should be recorded and final report issued, including a reconciliation between delivered and recovered products
  • effectiveness of recall procedure should be evaluated regularly
43
Q

self-inspection

A

chapter 9

  • should be carried out at periodic intervals in accordance with pre-arranged program
  • areas covered during self-inspection should include production, QC, premises, equipment, personnel, documentation, etc. (all 9 chapters and relevant annexes of PICS GMP standard)
  • conducted in an independent and detailed way by designated competent persons from company
  • independent audits by external experts are also useful
  • should be recorded, covering observations made during inspections and proposed CAPAs
  • statement(s) of eventual action(s) taken should also be recorded
44
Q

Are all annexes mandatory?

A

No!

45
Q

What are the annexes for?

A

stipulates additional requirements for various types of medicinal products and gmp-related matter

46
Q

PICS GMP standard - 20 annexes

A
  1. manufacture of sterile products: sterilisation and clean rooms
  2. manufacture of biological products: proteins susceptible to heat and low pH
  3. manufacture of radiopharmaceuticals: short shelf lives
  4. manufacture of (non-immunological) veterinary products - not regulated in sg
  5. manufacture of (immunological) veterinary products - not regulated in sg
  6. manufacture of medicinal gases eg. nitrous oxide for anaesthesia
  7. manufacture of herbal medicinal products: prone to microbial growth
  8. sampling of starting and packaging materials
  9. manufacture of liquids, creams and ointments
  10. manufacture of inhalations
  11. computerised systems: electronic records and data integrity awareness (GDocP and data integrity)
  12. use of ionising radiation in manufacturing
  13. manufacture of investigational medicinal products (clinical trial pdts)
  14. manufacture of blood products: screening of plasma/blood donors
  15. qualification and process validation: assuming product homogenity
  16. qualified person (QP) and batch release: applicable to EU only - not applicable in SG
  17. parametric release (batch release based on critical parameters)
  18. empty (previously GMP standard for APIs - renamed PICS guide to GMP part 2)
  19. reference and retention samples: ongoing stability testing and disputes
  20. quality risk management: voluntary

PR3145 (6 decks)

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