Roles and Duties Flashcards
Who is RPI? How is he/she different to RP role?
RPi - responsible person for import, much newer entity. Like a QP there is a list of qualifications to apply and an assessment carried out by the MHRA.
Role is to assess medicines manufactured and certified in the EU and then subsequently distributed to the UK, assess supply chain, any temperature excursions, that certification has been carried out. to then certify product to the UK market.
RP - responsible person.
Role is to ensure good distribution practice is adhere to throughout the supply chain. Ensure product is purchased from approved suppliers, handled to comply with GDP principles and storage conditions stipulated and distributed in the same way.
Give us the details of training plan for a QP when moved to a site where you have to work on a different dosage form ?
Assess if they have worked in this area before and if they have competence. If they do not, can arrange formal training. Alongside this:
1) Registered MA’s of the dosage form
2) read and understand SOP’s
3) observe personnel and spend time on the line
4) current QP’s - spend time to understand current problems and things to look out for
All tasks carried out prior to variation to add QP to licence.
Supply chain scenario: API site is moving from UK to India. Finished product site is moving from UK to South Africa. What documents would you require and how would you manage this change?
API - technical agreement, audit, supplier questionnaire, GMP certificate
FP - technical agreement, audit (preferably certifying QP), supplier questionnaire, GMP certificate, supply chain assessment/pedigree, handling of samples
What can you tell me about Brexit from a QP perspective?
Brexit amendment: 2019/775
Translated all current EU law to UK law. Anything new that came into effect doesn’t apply.
RPi required for EU certified product. To mfr in UK, product must be tested and released in EU for EU distribution.
Have you heard of regulation 174?
Regulation 174 allows a temporary sale/supply in response to a pathogen, toxin etc.
Supply Chain Question - Capsule heart drug - API manufactured in India, manufactured and primary packed in USA, secondary packed and certified in GB. What are the considerations for a QP? How does QP certify?
API - technical agreement, compliance to ICH Q7, audit, DMF/CEP? how are changes notified. QP declaration.
Mfr - audit of mfr site, technical agreement, compliance to MA and relevant sections to MA, understanding of QA release of bulk, transportation of bulk capsule from USA to UK.
Testing - UK MHRA approved site.
QP Code of Conduct states you can delegate – which of these can you delegate?
All but the legal duties. Should have oversight of the delegated duties, this could be through Management Reviews, KPI’s, QP forum
Your supplier of tablets has lately had three batches of broken tablets received which is out of character; they have asked you to audit their site to help them resolve this. When you arrive you realise that the QA department is not aware of the issues – what are your concerns?
Change of leadership and culture on site, working in silos, and root cause
Communication between the teams, any quality records raised, impact assessment - which other products does it impact, compliance with MA (if held by QA, how will mfr know), communication of changes
Scenario, supply chain: API is made in China, dosage form is made in Turkey, primary & secondary packaging is performed in Switzerland, final release in UK.
There then followed lots of questions around supply chain including API declarations, importing white lists (when to use, when not to use),
Who does the UK have an MRA with?
What documents would you expect from each site?
Technical Agreements, who would you recommend has to test the product
What is your understanding of authority audits?
What documents do you need for raw materials to assure quality?
What do EDQM do?
API (China) –> Bulk (Turkey) –> Packaging (Switzerland) –> Certification (UK)
UK QP needs to assess API manufacturer and ensure compliance to ICH Q7 before QP declaration. Letter of written confirmation required for each batch of API from China. Not on the white list.
Mutual recognition agreement allows regulatory inspections to be recognised by different states e.g. Canada, Switzerland, USA, Japan, Australia and New Zealand.
API - technical agreement, letter of written confirmation, QP declaration, audit
Bulk - technical agreement, GMP certificate, audit
Packaging - TA, MIA certificate, audit
Testing can be UK (MHRA approved site), although can be accepted if carried out in Switzerland. Must have relevant MA documentation available and the site audited and TA in place.
Carried out to assess GMP compliance, can be recognition between regulatory authorities.
Assure Quality - CEP or DMF material? technical agreement, letter of written confirmation, QP declaration, audit.
EDQM - assess API to see if pharmacopeial standard, issue CEP’s, work with regulatory authorities to build in harmonisation
List of countries approved for Batch testing
EU
EEA (Norway, Iceland, Lichenstein)
Australia
Canada
Israel
Japan
New Zealand
Switzerland
United States of America
Which countries have equivalent regulatory standards for the manufacture of active substances for the UK (White list)?
EU
EEA (Norway, Iceland, Lichenstein)
Australia
Brazil
Israel
Japan
Republic of Korea
Switzerland
United States of America
You mentioned the Quality Management System, please tell me how do you know if it is an effective system?
a. List the top three KPIs?
b. How do you measure CAPA effectiveness?
Review of the engagement of senior management with the QMS, principles of ICH Q10 built in, quality management review and self inspections give a holistic review.
a.
Metrics
no. of deviations opened vs overdue
no. of complaints vs deviations vs batches mfr’d
no. of CAPA’s past due date
Procedures
SOP covers all activities and adherence
Training of personnel to SOP’s
Dynamic
cGMP topics encompassed within
adaption of cGMP
b. to ensure the CAPA has been effective in addressing the root cause of the issue but also not having other negative impacts.
What are the recall classifications?
a. For a NatPSA recall, at what level do you retrieve your product? E.g. pharmacist
level? timeline?
b. For a class 2 recall, at what level do you retrieve your product? timeline?
c. Where can this information be found?
NatPSA, Class 2, 3, 4, company led
a. patient level, as soon as possible
b. could be patient level, within 48 hours.
c. DMRC guidance.
Importation of bulk product from the USA, packaging and certification in the UK, as a QP what are your concerns what would you want in place?
a. Reference and retention – where should they be stored?
Mfr - audit of mfr site, technical agreement, compliance to MA and relevant sections to MA, understanding of QA release of bulk, transportation of bulk from USA to UK, supply chain pedigree, GMP certificate from FDA.
Reference sample: sample of a batch of starting material, packaging material or finished product which is stored for the purpose of being analysed should the need arise during the shelf life of the batch concerned.
Retention sample: a sample of a fully packaged unit from a batch of finished product. It is stored for identification purposes.
SM and bulk samples kept at mfr site
packaging and retention samples stored at UK site.
Describe key elements of a pharmaceutical quality system
Aim of the PQS to ensure quality is built into each stage of the process, which is proceduralised and adhered to by trained personnel.
Policies - describe the PQS e.g. Quality manual/policy, SMF, data integrity, validation master plan
Procedure - covering key areas e.g. change control, CAPA’s, deviation, quality management reviews, risk assessments, complaints, handling of returns and recalls, self - inspections. manufacturing SOP’s, training.
Records - BMR, BPR, protocols and reports e.g. validation, QMS topics above records .e.g deviations, CAPA’s SI’s, training records.
Chapter 1 and ICH Q10
