PQS

Question 1

What would be in a technical agreement

Answer 1

Legal name and address, responsibilities, technical information, change controls, specifications and procedures, inspections, responsible personnel and contacts, complaints handling, defects, recalls, samples, deviations, records, release for use - signatures of agreement

Question 2

What is the structure of the PQS

Answer 2

As per chapter 1 and ICH Q10 quality system ensures quality, safety, efficacy and product is fit for purpose throughout its lifecycle, it should be documented in policies, sops and work instructions. It includes self inspections, change controls, outsourced activities, complaints, investigations, CAPA etc.
An effective PQS should be monitored and its effectiveness documented (management review, self inspection, KPIs)

Question 3

How do you know if it is an effective system?

Answer 3

Quality management reviews, KPIs, self inspections

Question 4

List the top 3 PQS KPIs

Answer 4

Repeat deviations, timeliness, action completion e.g capa, self inspection, pqrs etc

Question 5

How do you measure CAPA effectiveness?

Answer 5

Repeat deviation rate

Question 6

Any guidance on reference and retains samples?

Answer 6

Annex 19

Question 7

What tools would you expect to use in QRM?

Answer 7

Proactive FMEA and TORA. Reactive timelines, fishbones and 5 whys.

Applicable risks should be document in the site quality register

Question 8

What do you understand by Data Integrity, ALCOA and why is this important?

Answer 8

Its about clearly documenting the facts at the time, on recoverable media and being accountable - Attributable, legible, contemporaneous, original and accurate

Question 9

When would you expect to revalidate computerised systems?

Answer 9

I would look to Annex 11, annex 15 qualification and validation and GAMP5 for guidance and carry out a risk assessment, particularly following any changes to computerised systems hardware or software

Question 10

What is the first principle of GMP?

Answer 10

Documentation - if its not written down it did not happen

Question 11

How would you approve a raw material supplier?

Answer 11

Start with a supplier questionnaire. Carry out on onsite audit and supplier risk assessment. Receipt testing

Question 12

What do I need to consider if I have a new supplier for glass vials?

Answer 12

What needs to be done etc Start with a supplier questionnaire. Carry out on onsite audit and supplier risk assessment. Receipt testing. Specification for glass (whats it used for - glass type) Review of packaging requirement for safe shipping

Question 13

Why is glass thickness important?

Answer 13

For vial strength and product protection

Question 14

Sampling, AQLs - what types etc

Answer 14

Follow ISO2859 to develop sampling plan and confirm defect types and number accept / reject.

Question 15

For what product is thickness at base important

Answer 15

freeze dried

Question 16

You mentioned that during development there shall be changes as you optimise your formulation and process, where would you expect to find details on such changes?

Answer 16

IMP Dossier and PDF

Question 17

What are the key features of a deviation system

Answer 17

unplanned change - Timebound, QRA - levelling etc, RCA, CAPA, E Check, repeat trending

Question 18

What are your views on the use of Product Specification Files, do these assist the QP in their release decision?

Answer 18

One of the legal duties of an IMP QP is the ensure each batch is manufactured and assembled in line with the PSF prior to release for clinical evaluation

Question 19

What are the key attributes of a change control system / how would you design one?

Answer 19

Raise Change Control
Understand AS is and To be
Assess the impact of change
Document a high level plan and associated change actions
Requirement to append and review evidence of completed actions
Effectiveness checked
All changes should be reviewed and have input of multidisciplinary team and pre pre approved before any changes made and post approved following action completed and implementation by technical and QA

Question 20

You come to a new company which hasn’t got a quality management system – what would you introduce?

Answer 20

I would start with a quality policy and change control process which I would then use to raise a change control and work through chapter 1. I would risk assess the gaps and prioritise policies and procedures from there

Question 21

How are adverse drug reactions recorded / monitored?

Answer 21

Any notification to the company will be logged and investigated through the complaints process. The PVQP will monitor the internal complaints system but also surveillance of the UK yellow card system of anything logged externally from the market

Question 22

What do you look for when auditing an API facility?

Answer 22

I would start with the PQS to make sure this is under controls - PQR, Deviation, Change control, supplier management etc. I would complete a facility tour and walk the process. I would look at the part of the facility used to manufacture our API. I would be interested in how certain processing steps are completed such as crystallisation, rework and reprocessing

Question 23

What if the facility is heavily automated with microprocessors?

Answer 23

Then computer validation and data integrity would be a focus

Question 24

As a QP how would you reassure yourself that a PQS is effective and fit for purpose?

Answer 24

Management Review Meetings to review KPI’s, Overdues
Audit record (Internal / External) – number of observations raised
Deviations – Repeats / Critical / Unexpected
Complaints – Critical , associated KPI’s

Question 25

What would you expect to see in a good deviation system?

Answer 25

Closed on Time
No repeats
Categorisation – Minor / Major / Critical
Unexpected Deviations should be Clear
Risk Assessment, Scope & Containment, Root Cause Analysis Tools, Clear Batch Disposition, CAPA,
Clear KPI’s to demonstrate performance and control

Question 26

How do you monitor/measure that a QMS is working effectively?

Answer 26

Management Review
KPIs – Examples (Deviations, CAPA, Complaints, Rejects)
PQRs
Risk Management Techniques

Question 27

Whats is a standard complaints process

Answer 27

Log
Acknowledge
assess falsified - is this my product
risk assess from EMEA guidance
Sample
investigate (batch record, retain)
CAPA
feed back
trend

Question 28

What are the main steps of a deviation process

Answer 28

Timebound
QRA - levelling etc
RCA
CAPA
E Check
repeat trending