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About

The Qualified Person (QP) plays a critical role in ensuring that every batch of medicinal product released to the market has been manufactured, tested, and controlled in accordance with Good Manufacturing Practice (GMP), the Marketing Authorisation, and applicable regulatory requirements. Effective batch certification requires the evaluation of manufacturing records, quality system evidence, deviations, investigations, and supply chain controls to support informed and legally compliant release decisions.
This Qualified Person Responsibilities, Batch Certification and Batch Release Training Course & Certification provides comprehensive knowledge of QP legal responsibilities, EU GMP requirements, batch certification principles, evidence-based decision-making, Pharmaceutical Quality System oversight, manufacturing and testing review, importation and third-country manufacturing, deviations, changes, out-of-specification investigations, exceptional certification scenarios, digital batch release systems, inspection readiness, and regulatory expectations. Upon successful completion, learners receive a certification demonstrating their understanding of Qualified Person responsibilities and compliant batch certification best practices.

Who Should Enrol?

  • Qualified Persons (QPs) and QP Trainees
  • Quality Assurance and Quality Management Professionals
  • Qualified Person Delegates and Batch Release Personnel
  • Manufacturing, Production, and Operations Managers
  • Regulatory Affairs and GMP Compliance Professionals
  • Quality Control and Laboratory Professionals
  • Auditors and Pharmaceutical Quality System Professionals
  • Anyone involved in batch certification, batch release, or GMP compliance for medicinal products
📢 Every purchase also includes our FREE companion Qualified Person Responsibilities, Batch Certification and Batch Release eBook, designed to help you apply principles in real-world clinical trial settings.

What you will learn

Understand the legal responsibilities of the Qualified Person (QP), the principles of batch certification and batch release, and the regulatory framework governing medicinal product release.

Learn how to evaluate manufacturing, testing, deviations, changes, investigations, supplier oversight, and quality system evidence to support compliant batch certification decisions.

Develop knowledge of EU, EEA, UK, and third-country manufacturing requirements, importation controls, exceptional certification scenarios, and risk-based decision-making.

Gain practical understanding of Pharmaceutical Quality System oversight, inspection readiness, digital batch release systems, documentation, and best practices for defensible QP certification.

Course Syllabus

  1. Why the QP role exists
  2. Law and guidance are not the same
  3. The EU/EEA legal framework [EU/EEA]
  4. Annex 16 — status and reach [EU/EEA; adopted UK]
  5. The UK legal framework [UK]
  6. Great Britain and Northern Ireland can differ [GB vs NI]
  7. Post-Brexit importation recognition [UK/GB]
  8. UK-Only labelling and UK-resident QP [UK/GB]
  9. Manufacturing and import authorisation (MIA)
  10. Wholesale dealer's authorisation and the RPi [UK]
  11. The marketing authorisation binds certification
  12. The product specification file
  13. Certification, release and supply — the core distinction
  14. QP certification versus quality-unit release
  15. What Annex 16 asks the QP to confirm [EU/EEA; adopted UK]
  16. Who may act as a QP [EU vs UK]
  17. Organisational independence of the QP
  18. Reliance on systems and the single-QP-responsibility principle
  19. Rely on, but assure
  20. Relying on and challenging the PQS
  21. The certification register
  22. Continuous and ongoing certification
  23. The scope of professional judgement
  24. Judgement never overrides law or the MA
  25. Risk management underpins judgement [ICH Q9(R1)]
  26. Escalation — when and how
  27. Refusal to certify — the ultimate safeguard
  28. Handling and documenting a refusal
  29. Role of the marketing authorisation holder
  30. Role of the manufacturer
  31. Role of the importer [Annex 21 preview]
  32. Role of the quality unit
  33. How the roles interlock
  34. When to seek competent-authority interpretation
  35. Professional integrity and raising concerns
  36. Personal accountability of the QP
  37. Records that make certification defensible
  38. Common misconceptions about the QP role
  39. How authorisation, MA and certification interlock
  40. Senior management and the quality system [EU/EEA + UK]
  41. Deputy QPs and multiple named QPs
  42. QP knowledge and continuing competence
  43. The quality-control laboratory's role
  44. Sampling and testing responsibilities
  45. IMP release is a separate track [EU / GB / NI]
  46. Relying on MRAs and recognition [EU & UK, varies]
  47. Use current effective texts; drafts are not law [UK example]
  48. Contract givers and contract acceptors [preview]
  49. Quality and technical agreements [preview]
  50. Governance that protects the decision

  1. The evidence package as a whole
  2. Absence of a finding is not proof
  3. A certification checklist gives structure
  4. The batch evidence index
  5. The master batch record
  6. The executed batch record
  7. Reconciling the record against the standard
  8. Yield and material reconciliation
  9. In-process control results
  10. Finished-product specifications
  11. Starting-material and component specifications
  12. Analytical methods and their validation status
  13. Certificates of analysis — finished product
  14. Certificates of analysis — API and excipients
  15. Reading a certificate of analysis critically
  16. Pharmacopoeial versus registered specifications [type]
  17. Environmental monitoring data
  18. Process monitoring and critical parameters
  19. Utilities — water and gases
  20. Validation and qualification — the status question
  21. Process validation status
  22. Equipment and facility qualification
  23. Cleaning validation status
  24. Computerised system validation [preview]
  25. Ongoing verification keeps the state current
  26. Out-of-specification results
  27. Out-of-trend results
  28. The laboratory investigation phase
  29. The full investigation phase
  30. Deviations — planned and unplanned
  31. Assessing a deviation's impact on the batch
  32. Correction, corrective action and preventive action
  33. Open deviations and CAPA at certification
  34. Change control
  35. Changes against the marketing authorisation
  36. Post-approval changes and variations [EU vs UK]
  37. Unimplemented commitments
  38. Stability data and the batch
  39. Shelf-life, expiry and retest dating
  40. The ongoing stability programme
  41. Complaints and their relevance to the batch
  42. Prior batch history and trends
  43. Recalls and field-action history
  44. Data integrity — the ALCOA+ principles (rule 5)
  45. Electronic, paper and hybrid records
  46. Data-integrity red flags
  47. Supplier and material-source status
  48. Contract manufacturing site status
  49. Contract testing-laboratory status
  50. Quality and technical agreements in the evidence
  51. Traceability across the supply chain
  52. Reference and retention samples [Annex 19]
  53. Product quality review — purpose
  54. PQR trends and the QP
  55. Using trends to inform certification
  56. Assembling the complete package
  57. Cross-checking for consistency and conflict
  58. Recognising incomplete evidence
  59. Recognising conflicting evidence
  60. When to pause certification
  61. The certification decision, synthesised
  62. The NorthStar Cardizen dossier (fictional)
  63. Walking the Cardizen dossier (fictional)

  1. The three acts: certification, release and supply
  2. QP certification defined
  3. Quality-unit release defined
  4. Placing on the market / supply defined
  5. Jurisdiction labels for release across EU/EEA and UK
  6. The single QP responsibility with reliance
  7. What a manufacturing chain is
  8. Multiple sites, multiple authorisations
  9. Partial manufacture sites
  10. Packaging sites: primary and secondary
  11. Bulk versus finished-product certification points
  12. The site of certification
  13. Named QPs and organisational responsibility
  14. Contract manufacture oversight
  15. Contract laboratories: outsourced testing
  16. Why technical and quality agreements exist
  17. Technical agreement versus quality agreement
  18. What a quality agreement must define
  19. QP-to-QP confirmation: what it is
  20. What a QP-to-QP confirmation covers — and does not
  21. The chain of confidence in practice
  22. Contract-laboratory quality agreement specifics
  23. Practical workshop: quality-agreement gap assessment
  24. Common quality-agreement gaps
  25. Sampling responsibilities across the chain
  26. Testing responsibilities: where testing is done
  27. Representative sampling as a certification foundation
  28. Relying on testing at another EU/EEA site
  29. MRA and recognition: scope varies (Rule 4b)
  30. What may be relied on versus what must be verified
  31. Non-MRA considerations and the bridge to importation
  32. Decision: rely on partner testing or re-test?
  33. From certification to release to supply
  34. UK release: MIA, UK-resident QP, GB versus NI
  35. EU/EEA release
  36. 'UK Only' labelling from 1 January 2025
  37. Documenting the release decision
  38. Reference and retention samples defined (Annex 19)
  39. Who keeps samples, and where
  40. Quantities, retention periods and storage
  41. Remote access to records and remote certification
  42. Electronic batch records and reliance
  43. Audit trails and data integrity for QP reliance
  44. Practical workshop: supply-chain mapping
  45. When to seek competent-authority interpretation
  46. Starting-material and supplier oversight
  47. Handover documentation between sites
  48. Deviations and changes crossing site boundaries
  49. Transport and storage between EU/EEA sites
  50. Ongoing and continuous certification
  51. The register of certification
  52. Scope of the QP's batch-record review
  53. Sampling of imported products: a signpost
  54. Multi-site certification: pulling it together

  1. What importation means
  2. Why importation is tightly controlled
  3. The importer as MIA holder (EU/EEA)
  4. The QP's role for imported products
  5. Two source anchors: Annex 21 and Annex 16
  6. Annex 21 overview: importer responsibilities
  7. The importation site and its authorisation
  8. Oversight of third-country manufacturing sites
  9. Ensuring GMP equivalent to EU standards
  10. Batch documentation transfer to the importer
  11. Reference and retention samples for imports
  12. Physical versus fiscal importation
  13. Sources of third-country GMP assurance
  14. GMP certificates and inspection information
  15. Evaluating third-country GMP evidence
  16. The audit as primary assurance
  17. Risk-based audit strategy and frequency
  18. What a third-country audit must cover
  19. Falsified-documentation risk
  20. Import testing: the default expectation
  21. What import testing covers
  22. Sampling representativeness for imports
  23. Exemption from import testing via MRA
  24. What may be relied on versus verified (imports)
  25. Recognition arrangements and approved countries
  26. Non-MRA imports: full testing and oversight
  27. Certifying imported batches under Annex 16
  28. Exercise: the MRA decision (decision tree)
  29. The UK importation regime after Brexit
  30. UK jurisdiction: Great Britain versus Northern Ireland
  31. UK route 1: RPi on a WDA(H) for EEA imports
  32. What the RPi checks
  33. 'UK Only' labelling from 1 January 2025
  34. UK route 2: UK MIA plus UK QP certification
  35. UK-resident QP on a UK MIA
  36. RPi route versus UK MIA route
  37. Choosing the UK route: a decision aid
  38. Transport and storage for imported products
  39. Supply-chain security and falsified medicines
  40. Managing shortages and continuity of supply
  41. When to seek competent-authority interpretation
  42. Practical: import-case workshop
  43. Practical: third-country audit-risk assessment
  44. Serialisation and safety-feature verification
  45. Change control at the third-country site
  46. Parallel-imported and repackaged products
  47. Importation: pulling it together
  48. Importing active substances versus finished products
  49. Certification versus confirmation for imports
  50. Risk-based reduction of import testing
  51. Stability and storage-condition assurance
  52. Provenance and chain of custody
  53. Data integrity across borders
  54. Deviations discovered on import
  55. Out-of-specification results on import testing
  56. Documentation language and translation control
  57. Northern Ireland importation specifics
  58. Additional controls for sterile and biological imports
  59. Imported IMPs follow a different framework
  60. Inspection readiness for imported batches
  61. Common importation errors to avoid

  1. Why quality events matter at certification
  2. Three ideas to keep separate: correction, CAPA, release
  3. Certification, release and supply in an event
  4. The rule that bounds every decision
  5. The event lifecycle
  6. Quality risk management as the backbone
  7. Criticality: critical, major, minor
  8. Event criticality matrix
  9. Examples of critical events
  10. Deviations: planned versus unplanned
  11. Deviation from the MA versus from the process
  12. When a deviation touches the MA
  13. Judging investigation adequacy
  14. Correction, CAPA and remediation
  15. Product impact assessment
  16. This batch, other batches, other markets
  17. What an out-of-specification result is
  18. OOS, OOT and OOE
  19. The OOS investigation in two phases
  20. Confirmed versus unconfirmed OOS
  21. When an OOS may be invalidated
  22. Retesting, resampling and averaging pitfalls
  23. A confirmed OOS cannot be tested into compliance
  24. An OOS disposition decision path
  25. Reprocessing versus rework
  26. MA and validation constraints on remediation
  27. Extra testing and stability after remediation
  28. Remediation decision path
  29. Prospective, concurrent and retrospective validation
  30. Concurrent validation release risks
  31. Retrospective validation and ongoing verification
  32. Change control and certification
  33. Changes pending regulatory approval — the hard stop
  34. You cannot certify to an unapproved change
  35. Variation types and jurisdiction
  36. Timing: implementation versus approval
  37. Transition steps and drafts are not law
  38. Stability commitments and certification
  39. A confirmed stability failure and the market
  40. Impact on other batches and markets
  41. Stability commitments as a QP assurance
  42. What 'exceptional certification' means
  43. Handling an unexpected deviation at certification
  44. Conditions that must all hold
  45. Conditional certification and confirmatory testing
  46. An exceptional certification decision tree
  47. Documenting the exceptional decision
  48. Escalation and the option to refuse
  49. Refusal is a valid, documented outcome
  50. Exceptional decisions and the wider system
  51. Science- and risk-based documentation
  52. What a good QP decision record contains
  53. Escalation to QA, management and authorities
  54. Defective medicines and reporting interface
  55. Traceability of the whole decision
  56. Common QP errors in event handling
  57. The event-to-disposition workflow

  1. Why special products need additional controls
  2. Medicinal product is not an IMP
  3. Same principles, additional evidence
  4. The special-product landscape
  5. What 'additional controls' means
  6. Scaling controls to risk
  7. What an investigational medicinal product is
  8. Medicinal product versus IMP frameworks
  9. The IMP evidence basis
  10. IMP GMP framework — the jurisdiction split
  11. EU/EEA IMP framework in detail
  12. Great Britain IMP framework in detail
  13. Northern Ireland IMP framework in detail
  14. IMP release versus commercial certification
  15. Blinding, coding and unblinding risk
  16. IMP importation and the jurisdiction of release
  17. Comparators in clinical trials
  18. Blinded and assembled trial packs
  19. Maintaining the blind through release
  20. Why biological products are different
  21. Biological release evidence
  22. Cold chain for biologicals
  23. Sterile products and the contamination-control strategy
  24. Sterility assurance evidence at release
  25. Terminal sterilisation versus aseptic processing
  26. Vaccines and batch release
  27. Independent official batch release
  28. Vaccine-specific release evidence
  29. Cold-chain excursions and the QP decision
  30. Advanced therapy medicinal products
  31. Chain of identity and starting materials
  32. Releasing under short shelf-life ATMP pressure
  33. The QP's ATMP challenges
  34. Real-time release testing
  35. How RTRT rests on the control strategy
  36. Parametric release
  37. RTRT versus end-product testing
  38. An RTRT / parametric readiness decision
  39. RTRT control-strategy evidence
  40. Short shelf-life release pressures
  41. Radiopharmaceuticals as a short-life example
  42. Emergency and unlicensed supply concepts
  43. Concurrent constraints and short-life products
  44. Parallel trade and repackaging concepts
  45. Repackaging is a manufacturing activity
  46. Import, 'UK Only' labelling and repackaging
  47. Oversight of repackaged product
  48. Choosing the right additional evidence
  49. Common errors with special products
  50. When to seek specialist and competent-authority input
  51. IMP labelling, expiry and re-labelling
  52. Biosimilars and comparability
  53. Blood, plasma and derived products
  54. Combination and device-integral products
  55. Cold-chain mapping and monitoring
  56. Nucleic-acid and mRNA product handling

  1. What the pharmaceutical quality system is
  2. The ICH Q10 model and its spirit
  3. Rely on - and challenge - the PQS
  4. What 'an effective PQS' actually means
  5. Discipline rule 5: an absent finding is not proof
  6. Discipline rule 3: judgement within the law and MA
  7. Quality culture defined
  8. Healthy versus weak quality culture
  9. The QP's influence on culture
  10. Management review as a system
  11. Inputs to management review
  12. Quality metrics that inform release oversight
  13. Reading a metric critically
  14. Escalation routes and the QP's voice
  15. When a QP must escalate
  16. QP independence and freedom to decide
  17. Leading and lagging indicators
  18. The Product Quality Review
  19. What a PQR examines
  20. PQR, trends and the certification decision
  21. PQR for imported products
  22. Quality risk management and ICH Q9
  23. The two primary principles of QRM
  24. Risk-based oversight of the PQS
  25. QRM tools at a glance
  26. Formality and subjectivity in ICH Q9(R1)
  27. Risk review and residual risk
  28. Outsourced activities and the PQS
  29. Contract giver and contract acceptor
  30. Quality and technical agreements
  31. Supplier qualification and oversight
  32. Ongoing monitoring of contractors
  33. The QP's reliance chain on outsourced testing
  34. Governing the outsourcing web
  35. Inspection findings feed the PQS
  36. Tracking commitments to closure
  37. The QP and unresolved commitments
  38. Training and competence of release teams
  39. QP succession and deputies
  40. Knowledge management across the lifecycle
  41. QP workload and capacity
  42. Conflicts of interest and independence
  43. Business continuity for release
  44. Planning for QP unavailability
  45. A PQS maturity model
  46. A PQS maturity assessment matrix
  47. Common misconceptions about PQS oversight
  48. Continual improvement and the PQS
  49. Bringing PQS oversight together

  1. Why a controlled workflow matters
  2. Certification, release and supply in the workflow
  3. The end-to-end certification workflow
  4. Workflow design principles
  5. Trigger and entry criteria
  6. The decision and certification step
  7. Handoffs and controlled transitions
  8. Roles in the certification workflow
  9. Segregation of duties
  10. The maker-checker principle
  11. The QP's non-delegable certification act
  12. Electronic batch records
  13. EBR benefits and risks
  14. Review by exception
  15. The EBR and the evidence package
  16. Structured data and right-first-time
  17. The system landscape: LIMS, MES, ERP
  18. What each system does
  19. Interfaces and data flow
  20. Interface risks and controls
  21. Data integrity across interfaces
  22. The purpose of audit trails
  23. What a good audit trail captures
  24. Audit trail review
  25. Risk-based audit-trail review
  26. Data-integrity principles: ALCOA and beyond
  27. Electronic signatures
  28. Electronic-signature controls
  29. Signature meaning and binding
  30. Electronic signatures: jurisdiction note
  31. The data-review workflow
  32. Exception and deviation handling in-system
  33. Managing overrides
  34. The QP's review of exceptions
  35. The certification register
  36. What the register records
  37. Traceability of decisions
  38. Retention and retrieval
  39. Business continuity for electronic systems
  40. Planned versus unplanned downtime
  41. Manual and hybrid fallback
  42. Recovery and reconciliation
  43. Cybersecurity for release systems
  44. Access control and privilege
  45. Backup, recovery and change control
  46. Common misconceptions about digital certification
  47. Bringing the workflow together

  1. What a GMP inspection actually tests
  2. Types of inspection and who inspects
  3. The inspection evidence room
  4. Building the batch-record dossier
  5. The QP's own records and delegations
  6. Roles and conduct during the inspection
  7. Data and audit-trail readiness
  8. Preparing for the QP interview
  9. The three acts, under questioning
  10. Jurisdiction discipline under questioning
  11. Judgement within the law and the MA
  12. Handling 'what if' and uncertainty questions
  13. Demonstrating batch traceability
  14. The audit trail behind each step
  15. Reliance versus verification, evidenced
  16. Reference and retention samples in the trace
  17. Common QP and release deficiencies
  18. Deficiency: incomplete evidence and the silence trap
  19. Deficiency: data-integrity and audit-trail gaps
  20. How deficiencies are classified
  21. Responding to findings: the CAPA cycle
  22. Writing a credible CAPA commitment
  23. Documenting the decision: the QP memorandum
  24. A pre-inspection readiness self-assessment
  25. Document control and version discipline
  26. The opening meeting and agreeing scope
  27. The single-QP-responsibility principle
  28. Traceability across multiple sites
  29. Continuous and ongoing certification
  30. Deficiency: jurisdiction confusion
  31. Deficiency: product versus IMP confusion
  32. Root-cause analysis behind a finding
  33. Verifying CAPA effectiveness
  34. Escalation and management review
  35. For-cause and follow-up inspections

  1. 📘 Bonus: Qualified Person Responsibilities, Batch Certification and Batch Release eBook (Free with purchase)

Course Benefits

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Free eBook

Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with the current effective batch-certification framework and its jurisdictional divergence: EudraLex Volume 4 Annex 16 (Certification by a QP and Batch Release, operational 15 April 2016); Chapter 1 (Pharmaceutical Quality System); Annex 21 (Importation of Medicinal Products, operational 21 August 2022); Annex 17 (Real-Time Release Testing and Parametric Release); Annex 19 (Reference and Retention Samples); the EU IMP framework of Commission Delegated Regulation (EU) 2017/1569 with the new Annex 13 guideline; the UK Human Medicines Regulations 2012 (as amended); MHRA GMP guidance and the UK importation regime — the Responsible Person (import) on a WDA(H), the approved-countries route, 'UK Only' labelling from 1 January 2025 and the UK-resident QP on a UK MIA; the GB versus NI IMP split (Great Britain under Directive 2003/94/EC, Northern Ireland under Regulation (EU) 2017/1569); the Mutual Recognition Agreements whose scope varies by country and product type; and ICH Q9(R1) and ICH Q10 — as our training courses are constantly monitored, reviewed and updated. Drafts and consultations, such as the Great Britain future-strategy-for-batch-testing consultation, are identified as NOT law. Positions were verified in July 2026 and must be re-verified against the sources themselves, and for the relevant jurisdiction, before use.

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Learn from Industry Experts

The course content is Whitehall Training editorial material, developed to reflect established practice in QP batch certification, importation and release across the EU/EEA and UK frameworks — the way certification decisions are actually reasoned and defended, and the failure modes that appear when certification, release and supply are blurred or a jurisdiction is left unstated. It is built around a single fictional case study, NorthStar Medicines Ltd and its product Cardizen, with a canonical set of sites, scenarios and decisions, so that every certification, importation and disposition decision in the course is one the learner can reason through. Regulations, directives and GMP guidance are paraphrased and clause-referenced; they are never reproduced, and nothing in the course is legal advice or a regulator endorsement.


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