PRELIMS Flashcards

1
Q

GMP acronym

A

Good Manufacturing Practice

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2
Q

10 golden rules

A
  1. get the facility design right from the start
  2. validate processes
  3. write good procedures and follow them
  4. identify who does what
  5. keep good records
  6. train and develop staff
  7. practice good hygiene
  8. maintain facilities and equipment
  9. build quality into the whole product lifecycle
  10. perform regular audits
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3
Q

‘Sometimes you need to step back and reconsider the whole production area’

A

Golden Rule #1

Get the facility design right form the start

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4
Q

the aim of Lay out the production area

A

educe the chances of cross contamination and to avoid mix-ups and errors

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5
Q

don’t have final product passing through or near areas that contain intermediate products or

A

raw materials

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6
Q

A logical and well-planned layout will improve ____. Do not apply _____.

A

productivity; quick fix solutions

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7
Q

2 aims of facility area

A
  1. remove unnecessary traffic in the production area which could result in a hazardous environment
  2. segregate materials, products, and their components to minimise confusion and potential for mix-ups and errors.
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8
Q

what rule:
A company failed to keep the product manufacturing process linear. As the product moved through the factory, it was zigzagged from one area to another.

A

1

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9
Q

highlights of rule 1

A
  1. facility layout
  2. environment
  3. equipment
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10
Q

whats wrong w the sentence:

  • interior surfaces (walls, floors and ceilings) are rough, free from cracks and do not shed particulate matter
  • drains are sized adequately and have no trapped gullies
A

rough (smooth); remove no

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11
Q

how prove that equipment and processes consistently do what they are supposed to do?

A

testing and documentation is required

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12
Q

he key to maintaining safety and effectiveness of every product and enhances a company’s reputation for quality and reliability.

A

consistent performance

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13
Q

“Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.”

A

validation

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14
Q

All validation activities should be well planned and clearly defined by means of?

A

a Validation Master Plan, or VMP

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15
Q

Once this is complete, define the testing and documentation required.

A

consider all the critical parameters that may be affected and impact product quality

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16
Q

involved in validation

A
  1. Installation Qualification, or IQ,
  2. Operational Qualification, or OQ
  3. Performance Qualification, or PQ
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17
Q

which is testing to verify that the equipment is installed correctly

A

IQ

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18
Q

which is testing to verify that the equipment operates correctly

A

OQ

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19
Q

which is testing to verify that product can be consistently be produced to specification

A

PQ

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20
Q

highlights of golden rule 2

A

validation and change control

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21
Q

what should be prepared to complete the testing and provide a written report

A

A protocol describing each test and the acceptance criteria

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22
Q

Once testing is complete and the equipment or process is known to be controlled, it’s important to maintain its ‘_______’.

A

validated state

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23
Q

If a change to the validated state is required then it must be subject to

A

change control

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24
Q

should be in place to document all changes to facilities, equipment, or processes that may have an impact on product quality. You should evaluate the impact of the change and define the extent of re-validation.

A

a change control system

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25
Q

what rule:
Some years later an auditor discovered that changes had been made to the system. No re-validation work had been performed and the system was no longer in its validated state.

A

2

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26
Q

Procedures should be

A

clear, concise, and logical

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27
Q

whats wrong:

Having a dependent party reviewing your procedures also leads to process improvements.

A

independent

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28
Q

what rule: ‘Procedures should be clear, concise, and logical’

A

3

29
Q

Documentation requirements

The following documents are typical in the food, drug, and medical device industry:

A
  1. specifications
  2. operating instructions
  3. operating procedures
  4. records
30
Q

These detail the requirements with which products and materials have to conform, i.e. they serve as a basis of quality evaluation

A

specifications

31
Q

These detail material and equipment requirements and describe the steps to complete a task

A

Operating Instructions

32
Q

These give direction for performing certain tasks and provide higher-level instruction than operating instructions.

A

Operating Procedures

33
Q

These provide a history of each batch and provide a mechanism to check that you are following operating procedures and instructions.

A

records

34
Q

a useful tool in writing good prcoedures

A

flowchart

35
Q

Writing good procedures

Break the procedure into chunks and use:

A

 headings
 tables
 bullet points
 diagrams.

36
Q

whats wrong:
When writing procedures try to visualise the person that will use it. Use language they will understand and don’t include too much or too little information.

A

none

37
Q

whats wrong:

You can increase the readability of your procedures by using simple sentences and by writing in a formal style.

A

formal (conversational)

38
Q

what’s a usability test

A

Print out two copies of the procedure and ask someone unfamiliar with the task to follow it. Mark up the second copy with notes about where they found the document confusing. This will highlight problems with the document and is a great learning experience for the writer.

39
Q

Most companies have a___-year review cycle for their documents

A

3

40
Q

what rule:

Some operators resist following procedures because they think they have a ‘better’ way of working.

A

3

41
Q

Introduce a “_____” system within the work group where the team meets to discuss procedures that are not followed. Allow operators to suggest how they think a task should be performed and act on it

A

Better Operating Procedures

42
Q

2 reasons not to take a shortcut in following procedures

A

 Many shortcuts may create pitfalls that can be costly in the end.  Each step in a procedure has been included for a purpose.

43
Q

what rule:
Identify who does what
All employees should clearly understand what they have to do each day. It avoids misunderstandings and minimises the risk to product quality. You should create a job description for each role to define:
 job title
 job objective
 duties and responsibilities  skill requirements.

A

4

44
Q

Some areas that are vulnerable to overlap include:

A

 cleaning
 validation
 calibration.

45
Q

what rule
During a validation batch a series of samples were not taken as the operators thought that validation staff would take them, whilst validation thought that the operators would take them. The sampling responsibilities should have been detailed in sampling procedures and the validation documentation.

A

4

46
Q

‘If it’s not written down then it didn’t happen!’

A

golden rule 5

47
Q

enable you to track all activities performed during batch manufacture from the receipt of raw materials, to the final product release; they provide a history of the batch and its distribution.

A

good records

48
Q

what rule:

Companies need people who know how to the job right first time, every time’

A

6

49
Q

highlights of train and develop staff

A

training, demonstrating job competence,

50
Q

what rule:
To convince staff of the importance of washing their hands after toileting, ask the microbiology department to take fingerprint samples from each operator after they have washed their hands. They can then see how much bacteria is present on their ‘clean’ hands.

A

7

51
Q

what rule
Walk around your plant and check all the calibration stickers you can see. If they are out of date then your maintenance process is not being controlled properly

A

8

52
Q

prevents equipment breakdowns, which can be costly. It also reduces the risk of product contamination and maintains the ‘validated state’ of the facility or equipment.

A

regular equipment maintenance

53
Q

highlights of golden rule 9

A

controlling components
controlling the manufacturing process
packaging and labelling controls
holding and distribution controls

54
Q

must be conducted to assess whether you are following the GMP rules.

A

audits

55
Q

who conducts audits

A

External bodies such as the Food and Drug Administration (FDA) or the Therapeutic Goods Association (TGA)

56
Q

system to manage and fix anything found during an audit.

A

Corrective Action Preventative Action (CAPA

57
Q

self audit checklist highlights

A
written procedures
job competence
docu and validation
sanitation and cleanliness
maintenance of the workplace
quality control
58
Q

common but complex practice, process of exchanging messages between people

A

interpersonal communication

59
Q

core characteristics of an empathetic healthcare professional

A

understanding the perspectives of patients, communicating effectively, working from people from other disciplines

60
Q

intercom model

A
  1. sender
  2. message
  3. receiver
  4. feedback
  5. barriers
61
Q

who transmits the message

A

sender

62
Q

selection of words, symbols, etc.

A

encoding

63
Q

element that is transmitted

A

message

64
Q

method mode of comm (phone, email, ftf)

A

channel

65
Q

interpretation of what we just heard

A

decoding

66
Q

interference

A

barriers

67
Q

response of the message

A

feedback (positive and nega)

68
Q

4 types of barriers

A

physical, psychological, physiological, semantic