HACCP

Question 1

Which areas do the HACCP covered?

Answer 1

Critical operations and proceses in the manufacture and the safety of the personnel engaged in manufacture

Question 2

application of the HACCP in the pharmaceutical sector

Answer 2

patient risks to medication
water generation
medical device manfucture
quite often for environmental monitoring

Question 3

what is the objective of the HACCP?

Answer 3

is to prevent known hazards and to reduce the risks that they will case at specific points in the product

Question 4

Hazard is defind as?

Answer 4

any circumstance in the production, control and distribution of a pharmaceutical, which can cause an adverse health effects

Question 5

how are Hazard classified?

Answer 5

biological, chemical pr physical agnets or operations

Question 6

Hazard anaylsis is?

Answer 6

the process of colleting and evaluating information on hazards which should be addressed in the HACCP plan

Question 7

Critcial control Point is?

Answer 7

A step at which control can be applied and is essential to prevent or eliminate a phemaceutical quality hazard or reduce it to an acceptable level

Question 8

What are the 5 preliminary tasks of the HACCP?

Answer 8

1. Assesmble the HACCP team and define the scope
2. Describe the product and process
3. Identify the intended use of the resulting products
4. construct a process flow diagram
5. Verfication of the flow diagram

Question 9

Assesmble HACCP team should?

Answer 9

conduct a hazard anaylsis
identify potential hazrads
identify hazards which should be controlled
recommend controls and critical limits
devise procedures for monitoring and verification
verify the HACCP plan

Question 10

what is important when describing the product?

Answer 10

all products are defined through physical, chemical and biological characcteristics

Question 11

the process should depict?

Answer 11

process steps and equipment
Direct process control elemnets
indirect process control including cleaning and stoarage
Quality controls supporting rwa material and finished product release

Question 12

how many principle do the HAACP has?

Answer 12

7 principle

Question 13

Principle 1

Answer 13

List all potential hazards associated with each step, conduct a hazard analysis and consider any measures to control identified hazards

Question 14

Principle 2

Answer 14

Identity critical control points

Question 15

Principle 3

Answer 15

Establish critical limits for each CCP

Question 16

Principle 4

Answer 16

Establish a monitoring system for each CCP

Question 17

Principle 5

Answer 17

Establish an appropriate Corrective Action plan for each CCP

Question 18

Principle 6

Answer 18

Establish verification procedures

Question 19

Principle 7

Answer 19

Establish documentation and record keeping

Question 20

HACCP-FMEA : Specification unit

Answer 20

can be applied to each step of a planned process

Question 21

HACCP-FMEA : Hazard analysis

Answer 21

HACCP: only those( biological, chemical and physical hazards) that can cause harm to humans

FMEA: Hazards related to process capability of plants and machines
-Determination of product and process defects

Question 22

HACCP-FMEA : Risk assessment

Answer 22

HACCP: is carried out at the beginning of the method
FMEA: is the result of the method probability, impact and discovery of the defect are taken into account

Question 23

HACCP-FMEA : Risk assessment (2)

Answer 23

HACCP: RA results in highlighting required actions; it is differentiated between control points and critical control points

FMEA: Rs results are directly followed by concrete actions
Dependent on the defect, a graduated processding is possible