PQS Flashcards
What would be in a technical agreement
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
What is the structure of the PQS
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)
How do you know if it is an effective system?
Quality management reviews, KPIs, self inspections
List the top 3 PQS KPIs
Repeat deviations, timeliness, action completion e.g capa, self inspection, pqrs etc
How do you measure CAPA effectiveness?
Repeat deviation rate
Any guidance on reference and retains samples?
Annex 19
What tools would you expect to use in QRM?
Proactive FMEA and TORA. Reactive timelines, fishbones and 5 whys.
Applicable risks should be document in the site quality register
What do you understand by Data Integrity, ALCOA and why is this important?
Its about clearly documenting the facts at the time, on recoverable media and being accountable - Attributable, legible, contemporaneous, original and accurate
When would you expect to revalidate computerised systems?
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
What is the first principle of GMP?
Documentation - if its not written down it did not happen
How would you approve a raw material supplier?
Start with a supplier questionnaire. Carry out on onsite audit and supplier risk assessment. Receipt testing
What do I need to consider if I have a new supplier for glass vials?
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
Why is glass thickness important?
For vial strength and product protection
Sampling, AQLs - what types etc
Follow ISO2859 to develop sampling plan and confirm defect types and number accept / reject.
For what product is thickness at base important
freeze dried
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?
IMP Dossier and PDF
What are the key features of a deviation system
unplanned change - Timebound, QRA - levelling etc, RCA, CAPA, E Check, repeat trending
What are your views on the use of Product Specification Files, do these assist the QP in their release decision?
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
What are the key attributes of a change control system / how would you design one?
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
You come to a new company which hasn’t got a quality management system – what would you introduce?
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
How are adverse drug reactions recorded / monitored?
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
What do you look for when auditing an API facility?
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
What if the facility is heavily automated with microprocessors?
Then computer validation and data integrity would be a focus
As a QP how would you reassure yourself that a PQS is effective and fit for purpose?
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
What would you expect to see in a good deviation system?
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
How do you monitor/measure that a QMS is working effectively?
Management Review
KPIs – Examples (Deviations, CAPA, Complaints, Rejects)
PQRs
Risk Management Techniques
Whats is a standard complaints process
Log
Acknowledge
assess falsified - is this my product
risk assess from EMEA guidance
Sample
investigate (batch record, retain)
CAPA
feed back
trend
What are the main steps of a deviation process
Timebound
QRA - levelling etc
RCA
CAPA
E Check
repeat trending
