QP Code of Practice Flashcards
Can you describe duties of contract QP and where do you find them?
Code of Practice –
Contract QP’s In addition to compliance with the provisions applicable to all QPs including all the
practical duties detailed in Annex 16, Contracted QPs should observe the following:
Have a clear written contract, which delineates the duties and responsibilities of the QP – as agreed between the company and the ‘Contracted QP’. Both should sign and retain a copy of the contract;
Be on site for sufficient time to fulfil all legal and professional requirements;
Be readily available to the staff of the company for advice and discussion, be present during regulatory inspections and involved in communications with the inspectors;
Ensure that the company to whom the services are provided will allow free access to any people, information, documentation, premises, systems, etc. which are relevant to the decision-making processes when certifying batches; and
The QP must be informed and aware of any issues arising relating to the PQS that are relevant to a QP, in particular, any events that occur when the QP is not on site.
QP joining a new company, how do you become familiar with and confident in, the systems to enable you to certify product?
Familiarise with quality system (PQS under control), management team (responsibilities understood and adhered to) and product etc.
Have knowledge / experience of dosage form prior to applying to go onto license
QP Code of conduct - Ultimately, the QP must be satisfied either directly or, more usually, by the proper operation of the PQS, that manufacturing, packaging and quality control testing comply with the relevant requirements and that any deviations are controlled and managed effectively. These requirements apply whether the work is carried out on site or at a different site.
The QP depends upon many colleagues for the achievement of quality and regulatory compliance in the manufacture of medicinal products. It is therefore of paramount importance that the QP achieves good working relationships with others.
As a QP joining a new company what documents would you review?
What audits would you perform / review?
Who would you set up meetings with?
What other (regular) meetings do you need to attend?
What do you need training in?
What proof of compliance do you need to enable certification? – QP Checklist
MA’s – product specifications, approved packaging, core services providers (registered manufactures), Sterility Service Providers (If Applicable), QC testing
MIA
QP Responsibilities – Quality Agreements, Third Party Manufacturing
Site Master File – key stakeholders (Arrange Meetings)
Quality Manual
Validation Master Plan
Annual Product Quality Review
Supply Chain Maps
Critical Deviations / Complaints
Risk register
Review the last regulatory audit – findings CAPA resolved? API’s – QP Declarations Contract Laboratories, Packaging etc QC Gap Analysis of Annex 16 Batch certification Process Senior Leaders QP’s / Quality Manger – any shared responsibilities Head of Production Head of QC / Micro Reg Affairs PVQP Management Review – control of PQS, Leadership – investment and involvement, direction and strategy / large projects, understand risk approach (Risk Register) Quality Council – at least monthly , KPI’s Change Control Board – aware of major changes so QP can make assessment on suitability to implement change (Authority to say No) All Core SOP’s – Complaints , Deviations, Change Control etc Supply Chain Recall Procedures Product knowledge
QP Checklist
Associated NDA – US Market
Market Authorisation – EU Market
IND – Clinical US
PSF / CTA – EU Market
Have you been added to the MIA or MIA(IMP) as able to perform QP Certification
GMP - C of C
C of A
QP Checklist - Manufacturing Sites – registered, Artwork Registered, Destination Country Registered,
Safety Features – Tamper evidence, 2D Data Matrix, Check Country- Retention Sample
QP Register
QP code of practice contents
Covers:
GENERAL PRINCIPLES
PRACTICAL DUTIES OF A QUALIFIED PERSON - Annex 16
PERFORMANCE OF DUTIES AND REGULATORY COMPLIANCE
NUMBER AND LOCATION OF QUALIFIED PERSONS
CONTRACTED QUALIFIED PERSONS
OUTSOURCED ACTIVITIES
CONTINUING PROFESSIONAL DEVELOPMENT
PROFESSIONAL CONDUCT
PROFESSIONAL BODIES
DISCIPLINARY PROCEDURES
The 2024 QP Code of Practice
- Don’t mention the EU!
* This is most starkly illustrated by the wholesale banishment of EU legislation references. Thou shall refer to UK licencing authorities. As a result section 2 of the 2018 version (Regulatory basis for the Qualified person) is with us no more. Similarly, references to EU directives are no more.
* Annex 16 is only mentioned twice! And then it is the UK’s resolute Annex 16 of the MHRAs Orange Guide, Not that pesky EU Annex 16 which is a different thing altogether…
* Speaking of MHRA, its prominence drops significantly, to be replaced by the much less specific and flexible “Licencing Authority”. There is only one mention of the MHRA when not referencing the MHRA Orange Guide. - Modernisation
* Other than Brexit, several trends have impacted the QP and the refresh over 6 years reflects changes seen more broadly in the pharmaceutical industry and provides clarification to the original guidance. These clarifications include:
○ QPs responsibilities do not decline with an increase in the prevalence of home working, flexible or part time working.
○ Ensure that travel restrictions (such as COVID19 for example) do not impact your role.
○ There is a specific paragraph added to ensure remote QP certification is captured within the PQS. All activities that contract QPs undertake should be governed in the quality agreement with the contact QP.
○ Like with every bit of modern guidance ICH Q9 gets a shout out. Disappointingly the QP Notebook is not yet referenced. - More specificity in role and duties
* In three sections in particular (Introduction, Practical Duties of a Qualified Person and Performance of Duties and Regulatory Compliance there is much expanded discussion on the QP’s legal duty to ensure compliance with national laws, the requirements of Marketing Authorisations, and Good Manufacturing Practice (GMP). This is combined with increasing the importance of oversight and reliance on the PQS.
* There is an increased emphasis on the role of QP or Quality agreements, particularly for complex activities.
* In section 6.3, an important addition is the requirement to inform senior management of the legal role and responsibilities of a QP.
* In several sections the need to comply with the local legislation of the market into which the QP is certifying product is given greater emphasis.
* The section on disciplinary procedures has a interesting couple of additions to highlight that ignorance is not a viable excuse in our trade.
○ If it were found that a QP had intentionally or unintentionally certified a batch as fit for sale or supply without ensuring that the relevant tests and checks had been performed or was otherwise not in compliance with either GMP or the Marketing Authorisation / PSF, this would be considered by both the appropriate Professional Body and the Licensing Authorities as a matter of professional misconduct
* The slightly tweaked section on Continued Professional Development (CPD): Stresses the importance of ongoing professional development in response to evolving technologies and regulatory landscapes. - Little bits and pieces
* Finally the document is not without its little quirks.
○ Section 9.3 references section 10.1 when it should reference section 9.1 - oh the scandal! Its a subtle reminder that the old section 2 is no more.
○ Switzerland now has QPs! It just seems quirky that this gets a special shout out to me.
Overall, the revision is not a wholesale rewrite and its modest changes reflect the evolving regulatory environment, particularly in response to Brexit, and the need for QPs to adapt to new legal frameworks, technological advancements, and changing workplace norms.
