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PHA223 > aspetics > Flashcards

aspetics Flashcards

1
Q

What does GMP cover in manufacturing process?

A
  • quality management
  • personnel
  • sanitation
  • building, facilities, equipment
  • documentation
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2
Q

Why is documentation essential to GMP?

A
  • prevents errors associated with verbal communication
  • helps tracing of manufacturing history of pharmaceuticals
  • ensures reproducibility in all aspects of manufacturing
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3
Q

document specificity order (4)

A
  1. quality manual (least specific)
  2. company policies
  3. SOPs
  4. specifications, validation documents, batch records, logbooks
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4
Q

What are quality manuals?

A

a guide to introduce GMP for medicinal products and devices

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5
Q

What are company policies?

A

describe in general terms how specific aspects of GMP will be implemented
eg. how staff will receive training to do their jobs properly

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6
Q

What are SOPs?

A

a series of step by step instructions to help carry out complex routine operations

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7
Q

What are SOPs often based on?

A

specifications/requirements from the Pharmacopoeia and company policy

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8
Q

What is the focus of SOPs?

A

on the repetition of a process with no deviations

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9
Q

What do SOPs allow for?

A
  • consistency
  • allows for errors to be tracked and identified
  • can be used as a reference by employees
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10
Q

Who writes SOPs?

A

QC personnel

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11
Q

What are SOPs based on?

A

Pharmacopeia requirements and company policy

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12
Q

What are specifications?

A

exact requirements for raw materials, packaging materials and final products

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13
Q

What are validation documents?

A

documentation that provides a high degree of assurance that a planned process will perform consistently

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14
Q

What are batch records?

A

records specifically what happens for each batch

who made it, when, which equipment

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15
Q

What are logbooks?

A

forms used to record operations

cleaning, servicing etc.

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16
Q

4 stages of qualifications

A
  1. design qualification DQ
  2. installation qualification IQ
  3. operation qualification OQ
  4. performance qualification PQ
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17
Q

What does DQ demonstrate?

A

that the proposed design will satisfy all the requirements are suitable
eg. facility design

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18
Q

What is IQ?

A

ensuring equipment is installed, operated per manufacturer’s specifications and documentation is in place for continued use

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19
Q

What is OQ?

A

demonstrates that equipment/process works properly

establishes worst case scenarios

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20
Q

What is PQ?

A

demonstrates that process/equipment works properly over time

should maintain data to show performance over time

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21
Q

What is validation?

A

the process of getting evidence that your procedure maintains compliance at all stages

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22
Q

4 types of validation

A
  1. prospective
  2. concurrent
  3. retrospective
  4. revalidation
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23
Q

What is prospective in validation?

A

establishes documented evidence of what a system does based on a plan

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24
Q

What is concurrent in validation?

A

establishes documented evidence of what a system does based on a system that is implemented

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25
Q

What is retrospective in validation?

A

establishes documented evidence of what a system does based on previously acquired data

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26
Q

What is revalidation in validation?

A

process which occurs after a change in the process takes place which could have an impact on efficacy or safety
(when something goes wrong)

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27
Q

2 types of sterilisation?

A

terminally sterilised

aseptically manufactured

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28
Q

What is terminal sterilisation?

A

product is manufactured and packaged then subjected to a sterilisation process

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29
Q

What is aseptic preparation?

A

separate components of a drug subjected to sterilisation prior to packaging

30
Q

Which sterilisation could introduce a contaminant easier?

A

aseptic preparation

31
Q

Which sterilisation minimizes bioburden?

A

terminal sterilisation

32
Q

What sterilisation if preferred?

A

terminal sterilisation

33
Q

Why is terminal sterilisation preferred?

A
  • actually kills microorganisms

- reliable sterility assurance level can be calculated

34
Q

When is aseptic preparation used?

A

not all drugs can be terminally sterilised

  • API may require sterilisation by a different method to containers
  • API may require reconstruction before use due to stability issues
35
Q

3 methods used to assess risk of microbial contamination

A
  1. hazard analysis critical control points (HACCP)
  2. failure mode and effects analysis (FMEA)
  3. fault tree analysis (FTA)
36
Q

Where is hazard analysis critical control points used?

A

food industry

becoming more common in pharmaceutical manufacturing

37
Q

7 principles of HACCP

A
  1. perform hazard analysis and ID preventative measures for each stage
  2. determine critical control points (CCP)
  3. establish target levels and critical limits
  4. establish a monitoring system of CCPs
  5. establish what corrective action occurs when something goes wrong
  6. establish a verification system to make sure its working properly
  7. establish a record keeping system
38
Q

When is each principle of HACCP addressed first?

A

during initial design and IQ

39
Q

When are HACCP principles checked and monitored?

A

during OQ and PQ

40
Q

4 grades for facility design of sterile products (WHO/EU standards)

A

A, B, C, D

41
Q

When are grades C and D used?

A

clean areas for carrying out less critical stages in the manufacture of sterile poducts

42
Q

When is grade B used?

A

aseptic preparation and filling

background environment for grade A zones

43
Q

When is grade A used?

A

local zone for high risk operations

eg. filling zone, stopper bowls, open ampoules and vials, masking aseptic connections

44
Q

ISO standards compared to WHO/EU standards

A

ISO 1-8
A/B = ISO 5
C = ISO 7
D = ISO 8

45
Q

What is a cleanroom?

A

a contained space where airborne particulates are controlled and environmental conditions controlled as needed

46
Q

basic requirements for a cleanroom

A
  • floors, walls, ceilings: coated with chemically resistant materials
  • exposed surfaces: smooth and sealed to minimize accumulation of dirt
  • equipment, fixtures: can be on movable surfaces to facilitate cleaning
47
Q

other considerations for a clean room?

A
  • air locks: buffer zone prevention of contamination entry of all air substances/personnel into a clean room must occur via air-lock systems
  • interlocking system: ensures doors are never open at the same time, mechanical (high risk area) or alarm (low risk area)
  • separate entries/exits: for personnel, raw materials and products (pass thru hatch)
48
Q

When are the considerations for a clean room addressed?

A

during the DQ and IQ phases of setting up a facility

49
Q

How to reduce the risk of people contaminating a clean room?

A
  • ensure staff are properly trained
  • provide specialised equipment
  • minimize personnel in the clean room at one time
50
Q

What to wear at ISO level 8?

A

beard cover
hair cover
lab coat

51
Q

What to wear at ISO level 7?

A

beard cover
hair cover
lab coat

52
Q

What to wear at ISO level 6?

A 
beard cover
face mask
booties
coverall
gloves
hair cover
53
Q

What to wear at ISO level 5?

A 
beard cover
face mask
booties
coverall
gloves
hair cover
hood
54
Q

What to wear at ISO level 4?

A 
beard cover
face mask
booties
coverall
gloves
hair cover
hood
55
Q

What filters do clean rooms use for airflow?

A

HEPA or ULPA

56
Q

How efficient are HEPA filters?

A

remove 99.9% or particles > 0.3 micrometers

57
Q

How efficient are ULPA filters?

A

remove 99.999% of particles > 0.1 micrometers

58
Q

2 airflow principles in HEPA/ULPA filters?

A

laminar

turbulent

59
Q

What is laminar air flow?

A

unidirectional flow, constant velocity

influenced by wall curtains, machinery

60
Q

What is turbulent air flow?

A

random directions

non specific velocities

61
Q

3 types of airlocks?

A

cascade
bubble
sink

62
Q

How do airlocks work?

A

use pressure differences between spaces to stop particles moving between areas
usually 10-15 Pa between areas

63
Q

Where are samples taken for monitoring of clean rooms?

A
  • physical (pressure, particles, temp, RH)
  • microbiological
  • personnel (gloves, nails)
  • surfaces (swabs, contact plates)
64
Q

How often is monitoring done in each classification?

A 
grade A - once per shift
grade B - daily
grade C - weekly
grade D - monthly
UDAF B - once per shift
UDAF C - weekly
UDAF D - monthly
65
Q

How long are settle plates exposed for?

A

4 hrs
if less than 4hrs, limits applied
if process > 4hrs, change plates at 4hrs

66
Q

microbial limits in air samples for each grade A-D

A

A - <1 CFU/m squared (should be 0)
B - 10
C - 100
D - 200

67
Q

When are particulate levels monitored?

A
  1. in use - normal operations with personnel present
    part of routine environmental monitoring
  2. at rest - all equipment, control systems in place but not running, no staff present
    not part of routine environmental monitoring
68
Q

How are particles measured in particulate monitoring?

A

by a light scattering instrument

69
Q

What happens if limits are broken?

A

need to establish how and where problem has come from

70
Q

Why is aseptic preparation relevant to clinical pharmacy?

A

because not all drugs can be ready made

eg. TPN bags, chemotherapy and radiopharmaceuticals, extemporaneous preparations

PHA223 (43 decks)

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