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aspetics Flashcards

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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
What is retrospective in validation?
establishes documented evidence of what a system does based on previously acquired data
26
What is revalidation in validation?
process which occurs after a change in the process takes place which could have an impact on efficacy or safety (when something goes wrong)
27
2 types of sterilisation?
terminally sterilised | aseptically manufactured
28
What is terminal sterilisation?
product is manufactured and packaged then subjected to a sterilisation process
29
What is aseptic preparation?
separate components of a drug subjected to sterilisation prior to packaging
30
Which sterilisation could introduce a contaminant easier?
aseptic preparation
31
Which sterilisation minimizes bioburden?
terminal sterilisation
32
What sterilisation if preferred?
terminal sterilisation
33
Why is terminal sterilisation preferred?
- actually kills microorganisms | - reliable sterility assurance level can be calculated
34
When is aseptic preparation used?
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
3 methods used to assess risk of microbial contamination
1. hazard analysis critical control points (HACCP) 2. failure mode and effects analysis (FMEA) 3. fault tree analysis (FTA)
36
Where is hazard analysis critical control points used?
food industry | becoming more common in pharmaceutical manufacturing
37
7 principles of HACCP
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
When is each principle of HACCP addressed first?
during initial design and IQ
39
When are HACCP principles checked and monitored?
during OQ and PQ
40
4 grades for facility design of sterile products (WHO/EU standards)
A, B, C, D
41
When are grades C and D used?
clean areas for carrying out less critical stages in the manufacture of sterile poducts
42
When is grade B used?
aseptic preparation and filling | background environment for grade A zones
43
When is grade A used?
local zone for high risk operations | eg. filling zone, stopper bowls, open ampoules and vials, masking aseptic connections
44
ISO standards compared to WHO/EU standards
ISO 1-8 A/B = ISO 5 C = ISO 7 D = ISO 8
45
What is a cleanroom?
a contained space where airborne particulates are controlled and environmental conditions controlled as needed
46
basic requirements for a cleanroom
- 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
other considerations for a clean room?
- 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
When are the considerations for a clean room addressed?
during the DQ and IQ phases of setting up a facility
49
How to reduce the risk of people contaminating a clean room?
- ensure staff are properly trained - provide specialised equipment - minimize personnel in the clean room at one time
50
What to wear at ISO level 8?
beard cover hair cover lab coat
51
What to wear at ISO level 7?
beard cover hair cover lab coat
52
What to wear at ISO level 6?
``` beard cover face mask booties coverall gloves hair cover ```
53
What to wear at ISO level 5?
``` beard cover face mask booties coverall gloves hair cover hood ```
54
What to wear at ISO level 4?
``` beard cover face mask booties coverall gloves hair cover hood ```
55
What filters do clean rooms use for airflow?
HEPA or ULPA
56
How efficient are HEPA filters?
remove 99.9% or particles > 0.3 micrometers
57
How efficient are ULPA filters?
remove 99.999% of particles > 0.1 micrometers
58
2 airflow principles in HEPA/ULPA filters?
laminar | turbulent
59
What is laminar air flow?
unidirectional flow, constant velocity | influenced by wall curtains, machinery
60
What is turbulent air flow?
random directions | non specific velocities
61
3 types of airlocks?
cascade bubble sink
62
How do airlocks work?
use pressure differences between spaces to stop particles moving between areas usually 10-15 Pa between areas
63
Where are samples taken for monitoring of clean rooms?
- physical (pressure, particles, temp, RH) - microbiological - personnel (gloves, nails) - surfaces (swabs, contact plates)
64
How often is monitoring done in each classification?
``` 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
How long are settle plates exposed for?
4 hrs if less than 4hrs, limits applied if process > 4hrs, change plates at 4hrs
66
microbial limits in air samples for each grade A-D
A - <1 CFU/m squared (should be 0) B - 10 C - 100 D - 200
67
When are particulate levels monitored?
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
How are particles measured in particulate monitoring?
by a light scattering instrument
69
What happens if limits are broken?
need to establish how and where problem has come from
70
Why is aseptic preparation relevant to clinical pharmacy?
because not all drugs can be ready made | eg. TPN bags, chemotherapy and radiopharmaceuticals, extemporaneous preparations
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