PRELIMS

Question 1

GMP acronym

Answer 1

Good Manufacturing Practice

Question 2

10 golden rules

Answer 2

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

Question 3

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

Answer 3

Golden Rule #1

Get the facility design right form the start

Question 4

the aim of Lay out the production area

Answer 4

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

Question 5

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

Answer 5

raw materials

Question 6

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

Answer 6

productivity; quick fix solutions

Question 7

2 aims of facility area

Answer 7

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.

Question 8

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.

Answer 8

1

Question 9

highlights of rule 1

Answer 9

1. facility layout
2. environment
3. equipment

Question 10

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

Answer 10

rough (smooth); remove no

Question 11

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

Answer 11

testing and documentation is required

Question 12

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

Answer 12

consistent performance

Question 13

“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.”

Answer 13

validation

Question 14

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

Answer 14

a Validation Master Plan, or VMP

Question 15

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

Answer 15

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

Question 16

involved in validation

Answer 16

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

Question 17

which is testing to verify that the equipment is installed correctly

Answer 17

IQ

Question 18

which is testing to verify that the equipment operates correctly

Answer 18

OQ

Question 19

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

Answer 19

PQ

Question 20

highlights of golden rule 2

Answer 20

validation and change control

Question 21

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

Answer 21

A protocol describing each test and the acceptance criteria

Question 22

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

Answer 22

validated state

Question 23

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

Answer 23

change control

Question 24

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.

Answer 24

a change control system

Question 25

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.

Answer 25

2

Question 26

Procedures should be

Answer 26

clear, concise, and logical

Question 27

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

Answer 27

independent

Question 28

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

Answer 28

3

Question 29

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

Answer 29

1. specifications 2. operating instructions 3. operating procedures 4. records

Question 30

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

Answer 30

specifications

Question 31

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

Answer 31

Operating Instructions

Question 32

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

Answer 32

Operating Procedures

Question 33

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

Answer 33

records

Question 34

a useful tool in writing good prcoedures

Answer 34

flowchart

Question 35

Writing good procedures | Break the procedure into chunks and use:

Answer 35

 headings  tables  bullet points  diagrams.

Question 36

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.

Answer 36

none

Question 37

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

Answer 37

formal (conversational)

Question 38

what's a usability test

Answer 38

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.

Question 39

Most companies have a___-year review cycle for their documents

Answer 39

3

Question 40

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

Answer 40

3

Question 41

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

Answer 41

Better Operating Procedures

Question 42

2 reasons not to take a shortcut in following procedures

Answer 42

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

Question 43

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.

Answer 43

4

Question 44

Some areas that are vulnerable to overlap include:

Answer 44

 cleaning  validation  calibration.

Question 45

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.

Answer 45

4

Question 46

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

Answer 46

golden rule 5

Question 47

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.

Answer 47

good records

Question 48

what rule: | Companies need people who know how to the job right first time, every time’

Answer 48

6

Question 49

highlights of train and develop staff

Answer 49

training, demonstrating job competence,

Question 50

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.

Answer 50

7

Question 51

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

Answer 51

8

Question 52

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.

Answer 52

regular equipment maintenance

Question 53

highlights of golden rule 9

Answer 53

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

Question 54

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

Answer 54

audits

Question 55

who conducts audits

Answer 55

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

Question 56

system to manage and fix anything found during an audit.

Answer 56

Corrective Action Preventative Action (CAPA

Question 57

self audit checklist highlights

Answer 57

``` written procedures job competence docu and validation sanitation and cleanliness maintenance of the workplace quality control ```

Question 58

common but complex practice, process of exchanging messages between people

Answer 58

interpersonal communication

Question 59

core characteristics of an empathetic healthcare professional

Answer 59

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

Question 60

intercom model

Answer 60

1. sender 2. message 3. receiver 4. feedback 5. barriers

Question 61

who transmits the message

Answer 61

sender

Question 62

selection of words, symbols, etc.

Answer 62

encoding

Question 63

element that is transmitted

Answer 63

message

Question 64

method mode of comm (phone, email, ftf)

Answer 64

channel

Question 65

interpretation of what we just heard

Answer 65

decoding

Question 66

interference

Answer 66

barriers

Question 67

response of the message

Answer 67

feedback (positive and nega)

Question 68

4 types of barriers

Answer 68

physical, psychological, physiological, semantic