Presentation on EU GMP Annex 16 - Certification by QP

This presentation is compiled by “ Drug Regulations” a
non profit organization which provides free online
resource to the Pharmaceutical Professional.
Visit http://www.drugregulations.org for latest
information from the world of Pharmaceuticals.
12/11/2015 1

 This presentation is compiled from freely
available resources like the website EMA
specifically Revised Annex 16
 “Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
12/11/2015 2
Drug Regulations : Online
Resource for Latest Information

 Annex 16 was revised to
◦ Reflect the globalization of the pharmaceutical supply
chains
◦ Introduction of new quality control strategies
◦ Incorporate provisions of the Falsified Medicines
Directive (Dir 2011/62/EU)
◦ Implement ICH Q8, Q9 and Q10
◦ Clarify inconsistent interpretation by EU member states
12/11/2015 3
Drug Regulations : Online Resource for Latest
Information

 Annex 16 provides guidance on the certification by a
Qualified Person (QP) and batch release
 It applies to
◦ Certification/batch release within the European Union (EU)
◦ Medicinal products for human or veterinary use
◦ Principles also apply to investigational medicinal products (IMPs)
 Out of scope
◦ “Official Control Authority Batch Release” for some blood and
immunological products
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 Responsibilities
◦ The market authorization holder (MAH) is
responsible for the quality, safety and efficacy of a
medicinal product over its lifetime
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◦ The QP must ensure that each batch was
manufactured in compliance with
◦ The laws in force in the member state,
◦ The market authorization (MA), and
◦ With GMP
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◦ Batch release comprises three steps:
 Compliance check
 Certification
 Transfer to saleable stock/export
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◦ Batch release must be controlled to ensure
 Manufacturing & controls were done according to the MA
 Manufacturing & controls comply to GMP
 Any other relevant legal requirement was met
 Quality defects are investigated and acted upon
 (EU GMP Chapter 8)
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 QP must
 Certify each batch within the EU before
◦ Release for sale
◦ Supply in the EU
◦ Export
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 The QP must ensure that
◦ Certification is permitted under the terms
of the
 Manufacturing
 Importation authorization (MIA)
◦ Certification is recorded
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 QP
◦ Must have detailed knowledge of the steps for which
they are taking responsibility
◦ Should be able to prove their continuous training
regarding
 Product type
 Production processes
 Technical advances
 Changes to GMP
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 Sharing of responsibilities
◦ Each EU manufacturing site should have at least one QP
 The QP who performs certification can take full
ownership of all the steps of manufacture
 QP can share this responsibility with other QPs.
 Responsibility sharing must be documented and
agreed by all parties
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 Imported products
 QP must ensure that
◦ Physical importation and QP certification must
precede transfer to saleable stock
◦ Storage/transport conditions must be taken into
account
◦ Imported products were manufactured according
to the MA and GMPs
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 QP Must Ensure that
◦ Sampling at a third country-manufacturing site includes a Quality
Risk Management approach
◦ Sampling is fully documented and includes the following elements
◦ Audit of manufacturing, sampling and transportation activities;
◦ A comprehensive scientific study that demonstrates that samples
taken in the third country are representative of batches after
importation;
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 QP Must Ensure that
◦ A provision for random periodic analysis of samples taken
after importation;
◦ A review of any unexpected results or out of specification
result, including any follow up actions
◦ Different imported product batches originating from the
same bulk product batch
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◦ The QP certifying the different batches of
imported products may base their decision on the
QC testing of the first batch.
◦ This decision must be risk-based and
documented.
◦ Evidence should be available as to the integrity
and identity of each imported finished batch.
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 The QP must ensure the following tasks are
secured
◦ The entire supply chain is documented
◦ All sites and manufacturing and testing activities
are compliant
◦ A supplier quality management system is in place
◦ Active substances and excipients meet
requirements
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secured
◦ Records are complete; all in-process controls were done
and documented
◦ Processes are validated; personnel is trained and qualified
◦ Stability data and QC test data comply with specifications
◦ Post-marketing commitments are met
◦ Changes have been properly evaluated
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secured
◦ Investigations into out-of-trend, out-of-specification and
other findings were sufficiently completed
◦ The impact of any ongoing complaints, investigations or
recalls on certification has been assessed
◦ The self-inspection program is active and current
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 These tasks can be delegated to appropriately
trained personnel or third parties
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 Parallel importation and distribution
◦ Any repackaging operation performed on a batch that has
already been released must be approved by the competent
authority of the intended market
◦ The QP should confirm compliance with national
requirements/EU rules for parallel importation before
certification
◦ The QP of the MIA holder needs to certify that repackaging
was performed according to relevant authorization and GMP
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 Recording of the QP certification
◦ Certification must be documented in a register or
equivalent
◦ The record must be kept current and available for
inspection
◦ A control report or equivalent proof for release to
market needs accompany the batch
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 The QP can rely on third-party audits in assessing
pharmaceutical quality systems of manufacturing
sites
 This should be done according to EU GMP Chapter
7 (contract manufacture / analysis)
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 The audit reports should adequately address /
describe
◦ GMP compliance status of all audited areas
◦ GMP compliance status of the manufacture
◦ Quality control of the active substance and medicinal
product
◦ Conformity with the MA for any outsourced activity
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 The QP needs to ensure that
◦ Third party audit reports were assessed and approved
◦ Outsourced activities are classified according to
criticality of impact to product quality;
◦ Audit outcomes from critical suppliers are reviewed
◦ Repeated audits are performed according to a risk-
based approach
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 This section of the annex implements the main
features of the EMA Position Paper
 This pertains to QP Discretion
 This was issued in February 2006 and updated
January 2008
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 A batch with an unplanned/unexpected deviation
from details contained within the MA and/or GMP
may be certified if
◦ A risk assessment clearly indicates that the deviation has
no "adverse effect on quality, safety or efficacy of the
product"
 And
◦ As long as the registered specifications for active
substances, excipients and finished products have been
met
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 Batches can only be released for
sale/supply after QP certification
 Prior to certification, batches should remain
under quarantine
 Safeguards must be in place to ensure
batch segregation.
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 Segregation can be done either physically or
through the use of validated computerized
systems
 Steps to notify QP certification to the site where
transfer to saleable stock is to take place
should be defined in a technical agreement
 Notification should follow EU GMP Chapter 4
12/11/2015 29
Information

 This presentation is compiled from freely
available resources like the website EMA
specifically Revised Annex 16
 “Drug Regulations” is a non profit
organization which provides free online
 Visit http://www.drugregulations.org for
latest information from the world of
Pharmaceuticals.
12/11/2015 30
Drug Regulations : Online
Resource for Latest Information

Presentation on EU GMP Annex 16 - Certification by QP

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Presentation on EU GMP Annex 16 - Certification by QP