GMP

Question 0

GMP protects customers from

Answer 0

Purchasing a product that is not effective or is even dangerous.

Question 1

What is GMP

Answer 1

Quality assurance at ensures products are consistency manufactured and controlled to the quality standards appropriate for their intended use.

Warrants inplementation if set of privileges and procedures which when followed by manufacturers ensure product has required quality.

Eliminates insentces of contamination, mix ups, error.

Question 2

cGMP

Answer 2

Current good manufacturing practice.
Requires companies to use technologies and systems that are up to date.
Flexibility allows use of modern technologies and innovative approaches.

Question 3

Relevance of GMP

Answer 3

Manufacturing sites for MPs must have a manufacturing license.
Being GMP competent is a prerequisite.

Question 4

GMP ensure the …. 3 …. Of MPs

Answer 4

Safey
Quality
Efficacy

Question 5

QA

Answer 5

Organised arrangements ensuring products will be the quality required for their intended use

Question 6

GMP

In relation to QA QC

Answer 6

Ensuring products are consistently manufactured to appropriate quality

QC is part of GMP which is part of QA

Question 7

QC

Answer 7

Sampling, specification and testing of
Documentation and release procedures which ensure
Relevant tests are performed and the products is released only after ascertaining quality .

Question 8

What is essential for any process that can affect quality?

Answer 8

Detailed written procedures.

Question 9

The five ps

Answer 9

Premises
Primary materials
People
Procedures
Processes defined and recorded

Question 10

QA is a … Tool

Answer 10

Management

Question 11

Te total arrangements that ensure drug is continently of right quality …

Answer 11

Is QA

Question 12

GMP GCP and GLP are part of

Answer 12

QA

Question 13

GMP is part of QA that ensures …

Answer 13

Products are constantly produced and controlled ( diminishing risks that cannon be controlled by testing of the product - mixup, contamination)

Question 14

GMP includes system of complaints and recalls?

Answer 14

Yes

Question 15

Quality is measured as….

Answer 15

Fitness for purpose… GMP ensures this is built in

Question 16

Does self assessment play a role

Answer 16

Not at the moment - mistrust is assumed. But it is part of the ideal quality by design idea

Question 21

Roles of head of QC

Answer 21

Maintenance of his department, premises and equip

Approve starting materials, packaging, intermediates...
Approve contract analysts 
Evaluate batch record
Testing is carried out
Validations a done

Question 22

Qualified persons role

Answer 22

Ensure imported batch has undergone specified testing
Ensure UK batch has been produced in accordance with MA
Certify operations are carried out before any release
Must have qualification requirements laid down in article 23

Question 29

Guidelines regarding key personnel

Answer 29

Posts must be occupied full time
No gaps/up overlaps in responsibilities
Organisational chart of people responsible for specific duties in job descriptions & authority to carry them out.

Question 30

role of head of production

Answer 30

Maintenance of his department, premises and equip

Monitor storage and production according to documents
Approve prod instructions
Ensure followed
Evaluate and sign prod records before they are sent to QC
Validation

Question 31

Shared responsibilities of heads

Answer 31

Monitoring GMP compliance environment/plant hygeine/suppliers/contract manufacters
Testing samples, investigation, inspection
Authorisation of written procedures
Process validation
Training

Question 39

Ten principles of GMP

Answer 39

Document work
Validate "
Write step by stem written procedures
Follow """"
Design facilities and equip properly
Monitor facilities and equipment
Monitor components and processes
Monitor contamination
Design, develop, demo job competence
Audit