General

Question 1

What is the link between QMS and GMP?

Answer 1

2004.94.EC - Art 6: MFG shall establisha and implement and effective QMS + management particpation

Question 2

What are the essential elements of an effective QMS?

Answer 2

People:
Adequate number
Clear structure 
Sufficient training
Personnel hygeine
Plant/Equipment:
Design + locate + construct with operation in mind
Layout min risk
Secure
Qualified + PPM
Premises + equipment - cleaning
Poilcies and procedures:
Change controls
Customer complaints
Recall
Deviation Reporting Procedure
Risk management and Rx Ax
Audit and self inspection
Vendor assurance
MFG processes:
Tech transfer 
Define: Master formular + Spec + SOP + work instructions
Validated
Monitored - IPC
Maintained
Recorded, reviewed and approved
QC:
Suitable premises and people
Sampling procedure
Ref samples 
Validated test methods
Results reporting
Stability testing 
Warehouse + distribution
Product secure + protected
Controlled storage conditions
Traceability maintained throughout

Question 3

What are the eight quality management principles defined in ISO 9000:2000?

Answer 3

1. Customer focus: understand customers’ need
2. Leadership: establish unity of purpose and direction of the organisation
3. invovlvement of people: of all level
4. Process approach: manage activities as process
5. System approach to management: interrelated processes as system
6. Continual improvement:
7. Factual approach to decision making: data and information driven
8. Mutually beneficial supplier relationships

Question 4

What is meant by the Product Lifecycle?

Answer 4

Complete life of a medicinal product through the various stages of design, development, manufacture and distribution from the day of its conception

Question 5

What are the parts of a QMS?

Answer 5

Management support system: 
People management: organogram + training
Documentation management: SOP
Validation and Qualification: euquipment + process
Control of contrators and suppliers
Systme managing complaints and recall
Monitoring and feedback mechanisms
Self inspection

Question 6

Batch release system or final approval system

Answer 6

The design and development of the product and process
MFG syste and production controls
Packaging system and controls
Maintenance and monitroing of the facilities, utilities and equipment
Lab and analytical testing system
Control fo materials and suppliers
Distribution controls

Question 7

What are the two main principles of ICH Q9 QRM?

Answer 7

The evaluation of risk to quality should be based on sci knowledge and ultimately link to the protection of the pt
The level of effort, formality and documentation of QRM process hsoudl be commensurate with the level of risk

Question 8

What are the steps of QRM?

Answer 8

Rx ID
Rx analysis
Rx evaluation

Question 9

What are the product types that require dedicated facilites?

Answer 9

Penicillin and cephalosporins

Question 10

What are the product types that require clear separation?

Answer 10

Other antibiotics
Cytotoxics
Steroids and hormones
Raio isotopes
Narcotics - i.e. CDs
Other potent or sensitising drugs

Question 11

How can the products be separated?

Answer 11

Campaign working
Procedural controls
Use of validated cleaning procedures - can’t validate manual cleaning - need verification everytime

Question 12

Identify the key MFG stages that require separate segregated facilities?

Answer 12

Receipt, sampling and quarantine of RM
Quarantine and sampling of intermediates and finished products
Holding of rejected goods
Storage of released materials
Storage of packaging materials
Equipment washing
Ingredient weighing
MFG and processing operations
Packaging operations
Lab testing

Question 13

What does the term “design space” mean?

Answer 13

Established range of process parameters that has been demonstrated to provide assurance of quality
Working within the design space is not regarded as change

Question 14

What are the main considerations during Tech Transfer?

Answer 14

Clearly define responsibilities of development group and other - who is responsible for what
Communication: - how is the key information transferred
What criteria to use to meausre effectiveness of the transfer

Question 15

Describe a framework of validation management?

Answer 15

Overall corporate validation policy
VMP for each site, owned and managed by the validation steering committee on that site
A validation project must have a validation plan - could be part of another doc if small projects / more than one if big projects
Process / Equipment / Systems list - “to do” list

Question 16

What should a validation policy include?

Answer 16

Corporate wide scope
Commitment to validate
Responsibilities
Maintaining the validated states
Periodic review
Documentation
Processes/equipment out of scope

Question 17

What should a VMP include?

Answer 17

Site specific scope
Describe what to validate (how to validate is in SOPs)
Defines validation lifecycle
Roles and responsibilities i.e. steering committee
Change management during a validation project
Define vlidation review processand frequency

Question 18

What are the roles of a Validation Steering Committee?

Answer 18

Site wide responsibilities - local management team ensure vlaidtaion is done
Should include: PM, QC, Engineering, IT and validation
develop and maintain VMP
define local validation methodology
Set validation priorities
review progress
provide resources and resolve resource conflicts
approve changes to the methodology to be used
provide training
meet monthly
provide minutes of meetings for interested parties

Question 19

What should a VP contain?

Answer 19

define the scope of the validation project
ID the validation team and its role - who does what
Validation strategy: why do it this way
Roles and responsibilities
Timeline optional

Question 20

What are the EU classifications of recall?

Answer 20

Class 1: potentially life threatening or could cause a serious risk to health
Class 2: could cause illness or mistretment but not Class I
Class 3: may not pose a significant hazard to health
Class 4: The MHRA also issues “Caution in Use” Notices which are called a Class 4 Drug Alerts,
where there is no threat to patients or no serious defect likely to impair product use or
efficacy.These are generally used for minor defects in packaging or other printed materials

Question 21

What does ICHQ8 aim to deliver?

Answer 21

Q8 Pharm development
Product quality and performance achieved and assured by design of effective MFG process
Product spec based on mechanistic understanding of how formulation and process factors impact product performance
An ability to affect cont improvement and continous real tiem assurance of quality

Question 22

What is ICH Q10?

Answer 22

Q10: QMS
describe one approach to developing an effective pharmaceutical quality sys - based on GMP and iso
facilitate innovationg and cont improvement throughout the product lifecycle
embraces both Q8 and Q9 and seeks to promote knowledge managmeent and continual improvement of products, processes

Question 23

Things to remember

Answer 23

Water for irrigation sterile but 0.5 iu for endotoxins

When sterile question ask re parametric release

Question 24

List for audit

Answer 24

Qms- cc deviation 
Personnel- training and competence
Premises and equipment
Documentation
Production
Quality Control
Batch release and QP training 
Material handling returns and Shipping
Complaints, recalls