Role of QP Flashcards
(18 cards)
What are the roles of UK QPPV and where you can find them?
Roles:
- Ensure an effective PV SYSTEM is in place.
- Maintain and oversee the PVSMF.
- Act as the main PV CONTACT for the MHRA — must be available 24/7.
- Submit RISK MANAGEMENT PLAN & PSUR to MHRA
- Ensure SIGNAL DETECTION (trend analysis) and management systems are in place.
Legislation/guidance:
- UK SI 2012 PART 11
- MHRA Guidance on PV procedures
What is the differences API QP declaration and IMP declaration?
API QP declaration - for API manufactured EU GMP or equivariant
IMP declaration - for Imported IMP product have manufactured and tested EU GMP or equivalent.
You are a new contract QP at a company. What would you expect to see in your QTA to ensure you can perform your responsibilities?
QP Expectations in QTA – Bullet Summary
• Access Rights:
• SMF, PQR, audit reports
• Deviations, CAPA, complaints
• Batch records, validation docs
• QMS systems (electronic/paper)
• Facility & Personnel:
• Right to visit/audit facility
• Info on key equipment/staff
• Updates on changes affecting quality
• Certification Responsibility:
• QP responsible for final batch release
• No release without QP certification
• Notification of major deviations/recalls
• Decision-Making Clarity:
• Defined roles for batch disposition, rejection, recalls
• Training & Induction:
• Site-specific GMP/QMS training
• Induction to site processes, SOPs
• Communication:
• Contact points in QA, production, RA
• Escalation process defined
• QP Code of Practice Acknowledgement:
• Management recognises QP’s legal accountability
• Right to refuse certification
• Independence and professional judgement respected
• Alignment with MHRA Code of Practice
Role as a QP in managing stock shortages?
Key Responsibilities:
1. Early Identification and Escalation to the MAH
* If I become aware of a potential shortage—for example, due to rejected batches, manufacturing delays, or critical deviations—I would immediately notify the MAH or sponsor.
* This allows the MAH to assess the impact and, if necessary, submit a notification to the Department of Health and Social Care (DHSC).
2. DHSC Medicine Supply Notification (MSN)
* The MAH is responsible for reporting anticipated shortages or discontinuations to the DHSC using the Discontinuations and Shortages (DaSH) Portal.
* This is part of their obligation under the Health Service Products (Provision and Disclosure of Information) Regulations 2018.
* If appropriate, the DHSC issues a Medicine Supply Notification (MSN) to healthcare providers to help them manage the impact.
* (Source: gov.uk – DHSC MSN process)
3. Support for Mitigation Plans
* I may support or review risk assessments for:
* Temporary GMP deviations (e.g. minor label issues)
* Use of unlicensed products under Regulation 167
* Sourcing alternatives (e.g. importation under a WDA(H) or Specials Licence)
4. Maintaining Quality and Compliance
* Even during a shortage, I must not certify or release a batch unless it is fully compliant with GMP and the MA/CTA.
* I may be involved in regulatory discussions or deviations, ensuring decisions are documented, justified, and compliant.
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In Summary:
While I am not responsible for commercial stock management, I play a critical role in identifying and escalating risks, and in supporting the MAH’s obligations to notify the DHSC. My priority remains to ensure that only safe, compliant products are released, and that any mitigation measures protect both patients and regulatory integrity.
QP onboarding (training plan)?
Key Elements of a QP Onboarding Plan:
- PQS and Site Overview
- Read and understand high-level documents, including:
- Site Master File (SMF)
- Quality Policy and Quality Manual
- Organisational structure, QMS governance, and decision-making pathways
- Product and Process Familiarisation
- Review Product Master Files / Batch Manufacturing Records to understand:
- Critical Quality Attributes (CQAs)
- Critical Process Parameters (CPPs)
- Control strategies and batch release criteria
- Access to Key Records and Trends
- Review recent:
- Deviations, CAPAs, complaints, recalls
- Ongoing or recent quality investigations
- Product Quality Reviews (PQRs) to understand process capability and trends
- Practical Engagement (Gemba Walks & QA Oversight)
- Conduct Gemba walks and/or participate in internal audits to observe:
- Manufacturing, QC, and warehouse operations
- Personnel training and shop floor culture
- System and Tool Training
- Training in:
- Electronic systems (e.g. QMS, LIMS, documentation, batch tracking)
- QP certification systems/logs, where applicable
- Shadowing and Supported Release
- Shadow experienced QPs during certification
- Gradual increase in responsibility—e.g. from observation, to co-signing, to independent release
- Typical onboarding period: 6 to 9 months, adjusted based on product complexity and prior experience
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In Summary:
A robust QP onboarding plan ensures I am not only compliant with GMP, but also confident in applying site-specific knowledge to batch certification decisions. It must be documented, risk-based, and regularly reviewed to ensure readiness before signing QP declarations.
As a new QP to a role (in a OSD facility - not my dosage form) can you talk us through how you would familiarise yourself with the quality system and site and what you would want in your training plan?
Quality system:
Understand smf, quality policy, quality manual, bacth record for understand the product cpps, cqas.
Join quality meetings and read pqrs to understand the trend
Facility- Gemba walk, join daily handle, join regular audits.
Trina should inclue shadowing, support release for 6-9monthsq
- What KPI’s would I want to look at?
How long would you think you would take before feeling comfortable to be added to the licence?
PQR Element
Example KPI
Starting material & packaging quality
% supplier OOS; % incoming materials rejected
In-process controls & final product results
% OOS at IPC/QC; first-pass yield; trending drifts
Deviations & investigations
No. of deviations/month; closure within 30 days; repeat deviations
Batch failures
% batch rejection rate; rework rate
CAPA & change control
% on-time closure; repeat CAPAs; overdue changes
Stability data
Stability failures; out-of-trend results
Complaints and returns
No. of complaints per 10,000 packs; root cause trending
Recalls
No. of recalls; recall classification; mock recall performance
Equipment qualification & maintenance
% PMs completed on time; number of equipment-related deviations
Validation status
% cleaning validations overdue; number of open validation issues
Contract service performance
Supplier scorecards; number of audit findings
Regulatory commitments
No. of overdue commitments; variation implementation on time
Timeframe to Readiness:
I would expect a 6–9 month onboarding period, depending on:
Complexity of the products and processes
My previous experience with similar dosage forms or technologies
The maturity of the PQS and how well-documented site knowledge is
During this time, I would:
Complete product and QMS training
Participate in Gemba walks and batch reviews
Shadow experienced QPs
Assess site performance through historical KPIs and recent trends
Only once I am confident in the state of control and my own understanding of the site and product risks, would I agree to be added to the MIA(IMP) licence as a named QP.
You are a new QP joining a sterile manufacturer site, how would you ensure your training.
Model Answer:
Understanding GMP annex 1,
Understand site, product formulation, QMS, attend training with SMEs (CPPs, CQAs), participate in mock certifications. Propose a 6-month training plan to ensure readiness.
Tips: Even if pushed, say “6 months” for new formulations; 6–9 months for sterile products.
You’re moving from solid oral dosage to liquid manufacturing. What training plan do you need before batch certification?
Model Answer:
Understanding of GMP annex 9,
Understand site, product formulation, QMS, attend training with SMEs, participate in mock certifications. Propose a 6-month training plan to ensure readiness.
Tips: Even if pushed, say “6 months” for new formulations; 6–9 months for sterile products.
How would you onboard yourself as a QP in a new company (sterile and non-sterile forms)?
Tips: cover Eu GMP chapter 1-9
• Review the Site Master File, MIA license, and Quality Manual to understand permitted activities and QMS.
• Request the latest PQRs and recent MHRA inspection reports.
• Perform a Gemba walk to understand layout, people and material flow, and cleanliness.
• Review training records, including aseptic technique and gowning for sterile sites.
• Ensure access to product dossiers, validation summaries, and CCS documents.
If unfamiliar with the dosage form:
• Attend external courses or internal product-specific training.
• Shadow experienced QPs and production staff.
• Review manufacturing process flow, CPPs, CQAs, and EM trend data.
• Ensure robust understanding before taking batch certification responsibility.
You have been hired for a new site because they have had issues with their PQS and you are being brought in to make improvements – what would you want to see when starting this role?
Where can you find guidance on PQS?
Regarding PQR / APR – what would you expect to see in this?
a. What charts would you expect to see in a PQR
b. What would these charts be tracking
R & D site moving to your site. What is your concern?
You’ve been on holiday for 2 weeks and prior to going there were 6 batches that were OOS and you didn’t certify them. When you return, you find that all 6 batches have been released. What do you do?
- You’re the only QP. With the old QP having left. You’re told that’s what they always do.
- Who would you contact? What would you do about the batches?
You have been hired for a new site because they have had issues with their PQS and you are being brought in to make improvements – what would you want to see when starting this role?
How you update Regulatory change/update and why important?
Regular review of SI updates and EMA/MHRA blogs.
• Suggested answer: “As a QP, my legal duty is to comply with national law. To do so, I must stay updated with evolving legislation and regulatory expectations.”
What would your training plan as a new QP look like?
- Pre-start research on company/products.
- Define product types to certify.
- Follow training plan with shadowing, mock certification, SOP training.
- Estimated onboarding: 3 months (known site), 6–9 months (new dosage forms).
