Supported by a sector group of Presented by The APIC Audit Programme Thursday, 13 October 2005 Parallel Session The APIC Audit Programme presented by Dr

Supported by

a sector group of

Presented by

The APIC Audit Programme

Thursday, 13 October 2005

Parallel SessionParallel Session

The APIC Audit The APIC Audit ProgrammeProgramme

presented byDr Tom Buggy, DSM-Anti-Infectives B.V., The Netherlands

Dr. Barbara Jentges, Concept GmbH, Germany

Supported by

a sector group of

Presented by


• API GMP Audits – Regulatory Framework Directive 2001/83/EC as amended Restructuring of the EG GMP Guide API Audit expected by Competent Authorities in the Future?

• API GMP Audits - Need for Standardisation API GMP Audits – Problems with ... APIC/CEFIC Guidance Document APIC Auditing Guide

• Solution: The APIC AUDIT Programme Coordination by API Compliance Institute Steps in Managing an Audit Qualified and Certified Auditors Conclusions

• Discussion: Major Issues to look for in a GMP API Audit

The APIC Audit Programme – Overview

Supported by

a sector group of

Presented by


• API GMP Audits – Regulatory Framework Directive 2001/83/EC as amended Restructuring of the EG GMP Guide API Audit expected by Competent Authorities in the Future?

• API GMP Audits - Need for StandardisationAPI GMP Audits - Need for Standardisation API GMP Audits – Problems with ... API GMP Audits – Problems with ... APIC/CEFIC Guidance Document APIC Auditing GuideAPIC/CEFIC Guidance Document APIC Auditing Guide

• Solution: The APIC AUDIT ProgrammeSolution: The APIC AUDIT Programme Coordination by API Compliance InstituteCoordination by API Compliance Institute Steps in Managing an Audit Steps in Managing an Audit Qualified and Certified AuditorsQualified and Certified Auditors ConclusionsConclusions

• Discussion: Major Issues to look for in a GMP API AuditDiscussion: Major Issues to look for in a GMP API Audit


Supported by

a sector group of

Presented by


_________*) see Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal Products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC and Commission Directive 2003/63/EC (amending Dir 2001/83/EC, e.g. replacing is Annex 1) and Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the community code relating to veterinary medicinal products.

Prerequisite for placing on the market ...

QualityQuality

EfficacyEfficacy

SafetySafety

Placing on the Market *)

Chapter 1 Marketing Authorisation1. No medicinal product (veterinary product) may be placed on the market of a Member State unless a marketingauthorisation has been issued by theCompetent authorities of that Member State (...)“

Placing on the Market *)

Chapter 1 Marketing Authorisation1. No medicinal product (veterinary product) may be placed on the market of a Member State unless a marketingauthorisation has been issued by theCompetent authorities of that Member State (...)“

GMPGMP

API GMP Audits – Regulatory Framework

Supported by

a sector group of

Presented by


Responsibilities of the ‚Holder of a MA‘ - 1 -


For Medicinal Products for Human Use seeDirective 2001/83/EC as amendedArticle 46 (f) *)

‚The holder of a manufacturing authorisation shall at least be obliged(f) to comply with the principles and guidelines of good manufacturing practicefor medicinal products and to use as starting materials only active substances,which have been manufactured in accordance with the detailed guidelineson good manufacturing practice for starting materials.This point shall also be applicable to certain excipients, the list of which as well asthe specific conditions of application shall be established by a Directive adoptedby the Commission (...)‘‘

*) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC______MA = Manufacturing Authorisation

For Medicinal Products for Human Use seeDirective 2001/83/EC as amendedArticle 46 (f) *)

‚The holder of a manufacturing authorisation shall at least be obliged(f) to comply with the principles and guidelines of good manufacturing practicefor medicinal products and to use as starting materials only active substances,which have been manufactured in accordance with the detailed guidelineson good manufacturing practice for starting materials.This point shall also be applicable to certain excipients, the list of which as well asthe specific conditions of application shall be established by a Directive adoptedby the Commission (...)‘‘

*) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC______MA = Manufacturing Authorisation

Supported by

a sector group of

Presented by


Responsibilities of the ‚Holder of a MA‘ - 2 -

For Veterinary Medicinal Products seeDirective 2001/82/EC as amended

Article 50 (f) *)

‚The holder of a manufacturing authorisation shall at least be obliged(f) to comply with the principles and guidelines of good manufacturing practicefor medicinal products and to use as starting materials only active substances,which have been manufactured in accordance with the detailed guidelineson good manufacturing practice for starting materials.

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.______MA = Manufacturing Authorisation

For Veterinary Medicinal Products seeDirective 2001/82/EC as amended

Article 50 (f) *)

‚The holder of a manufacturing authorisation shall at least be obliged(f) to comply with the principles and guidelines of good manufacturing practicefor medicinal products and to use as starting materials only active substances,which have been manufactured in accordance with the detailed guidelineson good manufacturing practice for starting materials.

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.______MA = Manufacturing Authorisation


Supported by

a sector group of

Presented by


Responsibilities of the Distributors - 1 -

For Medicinal Products for Human Use seeDirective 2001/83/EC as amendedArticle 46a *)

1. ‚For the purposes of this Directive, manufacture of active substances used asstarting materials shall include both total and partial manufacture or import ofan active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I**), and the various processes of dividing up, packaging orpresentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by distributor of startingmaterials.‘*) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC**) see Annex I of Commission Directive 2003/63/EC of 25 June 2003, amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.

For Medicinal Products for Human Use seeDirective 2001/83/EC as amendedArticle 46a *)

1. ‚For the purposes of this Directive, manufacture of active substances used asstarting materials shall include both total and partial manufacture or import ofan active substance used as a starting material as defined in Part I, point 3.2.1.1 (b) Annex I**), and the various processes of dividing up, packaging orpresentation prior to its incorporation into a medicinal product, including repackaging or re-labelling, such as are carried out by distributor of startingmaterials.‘*) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC**) see Annex I of Commission Directive 2003/63/EC of 25 June 2003, amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use.


Supported by

a sector group of

Presented by


Responsibilities of the Distributors - 2 -

For Veterinary Medicinal Products seeDirective 2001/82/EC as amendedArticle 50a *)

1. ‚For the purposes of this Directive, manufacture of active substances used asstarting materials shall include the complete or partial manufacture or the import of an active substance used as a starting material as defined in Part 2, Section C of Annex I, and the various processes of dividing up, packaging orpresentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as are carried out by a starting material distributor.‘

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.

For Veterinary Medicinal Products seeDirective 2001/82/EC as amendedArticle 50a *)

1. ‚For the purposes of this Directive, manufacture of active substances used asstarting materials shall include the complete or partial manufacture or the import of an active substance used as a starting material as defined in Part 2, Section C of Annex I, and the various processes of dividing up, packaging orpresentation prior to its incorporation in a veterinary medicinal product, including repackaging or re-labelling, such as are carried out by a starting material distributor.‘

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.


Supported by

a sector group of

Presented by


Article 47*) / Article 51**)

‚The principles of good manufacturing practice for active substances used a starting materials referred to in point (f) of Article 46 (in Article 50(f)) shall be adopted in the form of detailed guidelines.

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.**) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC

Article 47*) / Article 51**)

‚The principles of good manufacturing practice for active substances used a starting materials referred to in point (f) of Article 46 (in Article 50(f)) shall be adopted in the form of detailed guidelines.

*) Citation from the Consolidated Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products as amended byDirective 2004/28/EC.**) Citation from the Consolidated Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use as amended by Directive 2002/98/EC, Directive 2004/24/EC and Directive 2004/27/EC

Detailed Guidelines on GMP for APIs

Annex 18 of EG GMP Guide


Supported by

a sector group of

Presented by


In order to fulfil the requirements laid down in article 47 of Directive 2001/83/EC as amended by Directive 2004/27/EC (relating to human medicinal products) and Article 51 of Directive 2001/82/EC as amended by Directive 2004/28/EC (relating to veterinary medicinal products), the Member States have now agreed – after discussion at EMEA’s ad hoc inspections Services group – that ‘Annex 18 will no longer be considered as annex, but it will form a new, Part II of the EU GMP Guide’ (see Ad Hoc GMP Inspections Services, Concept Paper on the revision of some annexes to the European GMP Guide in the context of the GMP for active substances, May 2005).

Within this restructuring the EU GMP Guide will be presented in 2 Parts: Part I dealing with finished products Part II dealing with active substances used as starting materials

(applicable for medicinal products for both, human and veterinary use).

Restructuring of EU GMP Guide - 1 -


Supported by

a sector group of

Presented by


Annex 18 EG GMP Guide: Good Manufacturing Practice for Active Pharmaceutical Ingredients

1.3 ScopeThis Guide applies to the manufacture of APIs for use in human drug

(medicinal) products.

Draft revision of the introductory section of the current GMP annex 18. (According to that, the current Annex 18

is foreseen to become Basic Requirements Part II, while thecurrent Basic Requirements are to become Part I).

1.2 ScopeThese guidelines apply to the manufacture of active substances for medicinal

products for both human and veterinary use with the exception of ectoparaciticides.

Restructuring of EU GMP Guide - 2 -


Supported by

a sector group of

Presented by


Need for Supplier Qualification

Good Manufacturing PracticesChapter 5 – Production

(from: The rules governing medicinal products in theEuropean Union, Volume 4, Good Manufacturing Practices; http://dg3.eudra.org)


Supported by

a sector group of

Presented by


GMP Audits – Tool for Supplier Qualification

Good Manufacturing PracticesChapter 5 – Production

(from: The rules governing medicinal products in theEuropean Union, Volume 4, Good Manufacturing Practices; http://dg3.eudra.org)Conducting a GMP Audit is

a major tool forsupplier qualification and gives

information about the GMP status

Conducting a GMP Audit is a major tool for

supplier qualification and gives information about the GMP status


Supported by

a sector group of

Presented by



Draft Guidance on the occasions when it is appropriate for CompetentAuthorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials

Principle‚(...) When an application for a marketing authorisation, or variation to change or add a new active substances manufacturer, is submitted, the applicant will be required to include a declaration from the manufacturing authorisation holderthat the active substance(s) concerned has/have been manufactured in accordance with the detailed guidelines on good manufacturing practicefor starting materials.‘

*) Citation from Draft Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of Manufacturers of Active Substances used as starting materials; http://dg3.eudra.org/F2/pharmacos/docs/Doc2005/03_05/ASM%20Inspections%20Guidance%20_final_20050303.pdf)


Principle‚(...) When an application for a marketing authorisation, or variation to change or add a new active substances manufacturer, is submitted, the applicant will be required to include a declaration from the manufacturing authorisation holderthat the active substance(s) concerned has/have been manufactured in accordance with the detailed guidelines on good manufacturing practicefor starting materials.‘


Competent Authorities expect API Audits - 1-

Supported by

a sector group of

Presented by




Principle‚It is expected that the holder of the manufacturing authorisation will basesuch a declaration on carrying out, or having carried out on his behalf,an audit of the manufacturers/distributors of the active substances concerned. Examinination, by inspectors, of the audit programmes usedby authorisation holders for conducting regular audits (every 2 – 3 years))including review of audit reports, is one of the primary means by whichCompetent Authorities will determine if manufacturing authorisationholders are in compliance with the above articles (...)‘



Principle‚It is expected that the holder of the manufacturing authorisation will basesuch a declaration on carrying out, or having carried out on his behalf,an audit of the manufacturers/distributors of the active substances concerned. Examinination, by inspectors, of the audit programmes usedby authorisation holders for conducting regular audits (every 2 – 3 years))including review of audit reports, is one of the primary means by whichCompetent Authorities will determine if manufacturing authorisationholders are in compliance with the above articles (...)‘


Competent Authorities expect API Audits - 2-

Supported by

a sector group of

Presented by


Emphasis on Compliance

MAA*)

GMP-Documentation

_______________________*) Marketing Authorisation Applicaton and accompanying documents

API Manufacture

Regulatory Compliance?


Supported by

a sector group of

Presented by


• API GMP Audits – Regulatory FrameworkAPI GMP Audits – Regulatory Framework Directive 2001/83/EC as amendedDirective 2001/83/EC as amended Restructuring of the EG GMP GuideRestructuring of the EG GMP Guide API Audit expected by Competent Authorities in the Future?API Audit expected by Competent Authorities in the Future?

• API GMP Audits - Need for Standardisation API GMP Audits – Problems with ... APIC/CEFIC Guidance Document APIC Auditing Guide




Supported by

a sector group of

Presented by


WHO GMP Guideline – Chapter 5 General advice on how to conduct audits in pharmaceutical companies

Principle Items for Self-inspection Frequency of Self-inspection Follow-up Action Quality Audit Supplier Audit

Guidance for conducting GMP Audits


Supported by

a sector group of

Presented by


ISO 19011:2002 Guidelines for quality and/or environment

management systems auditingThis international standard provides guidance on the management of audit programmes, the conduct of internal or external audits of quality and/or environmental management systems, as well as on the competence and evaluation of auditors. It is intended to apply to a broad range of potential users, including auditors, organizations implementing quality and/or environmental management systems, organisations needing to conduct audits of quality and/or environmental management systems for contractual reasons, and organizations involved in auditor certification or training, in certification/registration of management systems, in accreditation or in standardization in the area of conformity assessment.

Standard for Quality Audits


Supported by

a sector group of

Presented by


Problems may arise from ... - 1 -

Audit preparation!??

Flow chart of audit activities

API GMP Audits – Need for Standardisation

... a lack of standardisation for planning, conducting, and documenting the audit observations.

Supported by

a sector group of

Presented by


EDQM Inspection


Audit Plan

2006

Audits/Inspections expected from:

Customers

Authorities, e.g. FDA,

EDQM, EMEA

etc.


... an audit overflow

Supported by

a sector group of

Presented by


Is the documented

cleaning validation sufficient?

Does this water quality

fulfil therequirements

?



... untrained and helpless auditors

Supported by

a sector group of

Presented by




... unqualified conclusions documented in the audit report

Supported by

a sector group of

Presented by





Supported by

a sector group of

Presented by





Supported by

a sector group of

Presented by


ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC)

Auditing Guide


Solution: APIC Auditing Guide

APIC Auditing Guide(including 4 Annexes):

– Secrecy Agreement– Questionnaire– Aide Memoire– Audit Report

August 2002

Supported by

a sector group of

Presented by


http://apic.cefic.orghttp://apic.cefic.org

Supported by

a sector group of

Presented by




• Solution: The APIC AUDIT Programme Coordination by API Compliance Institute Steps in Managing an Audit Qualified and Certified Auditors Conclusions



Supported by

a sector group of

Presented by


APIC Audit Programme is the realisation of the APIC Auditing Guide

Supported by

a sector group of

Presented by


Coordination of the APIC Audit Programme

For the purpose of managing the auditsIn the framework of the APIC audit Programme, the ‚API Compliance

Institute‘ was founded on 19 Dec 2002

http://www.api-compliance.org

For the purpose of managing the auditsIn the framework of the APIC audit Programme, the ‚API Compliance

Institute‘ was founded on 19 Dec 2002

http://www.api-compliance.org


Supported by

a sector group of

Presented by


Standardized GMP Audits in compliance with the

principles laid down in the CEFIC/APIC Auditing Guide Experienced and trained auditors that are registered as

APIC certified auditors Standardized process for preparing and conducting audits Release of audit report

Controlled Costs Standardized audit costs

What are the aims?


Supported by

a sector group of

Presented by


Steps in Managing an Audit

Pre Audit Information Preparation of the Audit Performing the Audit Reporting and Response Follow up Possible Breakdown

Phases of an Audit


Supported by

a sector group of

Presented by


Appendix A: Secrecy Agreement

§ 1 The purpose of disclosure of the information is to enable the Auditors to conduct their audit in the facilities of the customer with a view into the quality related procedures.

§ 2The Auditor herewith declares his independence and assures the Auditee of not being employed or supported by a competing company of the Auditee.

§ 3The audit will be conducted in a way that is in accordance with the European Competition Law. It has to be taken care during the audit that no sensitive and/or technical information is given to the Auditors if the latter are working for a competing company. The Auditee reserves the right to refuse to disclose requested confidential information by the Auditor.

Purpose of this agreement is to protect theknowledge of the auditee to not be abused

by the auditor.

Purpose of this agreement is to protect theknowledge of the auditee to not be abused

by the auditor.


Supported by

a sector group of

Presented by


Appendix B: Pre-Audit Questionnaire... It is the purpose of the questionnaire to facilitate the preparation of the auditors for the audit at your company and to make it as efficient as possible. (...) Every information provided (...) will be treated strictly confidential ...

Chapters of Appendix B:

A. General Information about the companyB. Quality related informationC. Product related informationD. GMP related informationE. Comments from the auditeeF. Requested documents (e.g. CEP, DMF)

Chapters of Appendix B:

A. General Information about the companyB. Quality related informationC. Product related informationD. GMP related informationE. Comments from the auditeeF. Requested documents (e.g. CEP, DMF)


Supported by

a sector group of

Presented by


Appendix C: Aide Mémoire

General remark Chapters 1 to 19 of this Aide Mémoire refer to the appropriate chapters of ICH Q7a. Chapter 20 relates to aspects of Quality Management Systems according to ISO.

General remark Chapters 1 to 19 of this Aide Mémoire refer to the appropriate chapters of ICH Q7a. Chapter 20 relates to aspects of Quality Management Systems according to ISO.


Supported by

a sector group of

Presented by


Appendix D: Audit Report Template - 1 -


Supported by

a sector group of

Presented by


UrgencyClassification rating

The condition will seriously affect the quality of products, regulatory compliance. The condition violates essential GMP-rules and basic quality assurance practices. Immediate action should be taken.Example: Violation of regulatory documents, e.g. DMF or CEP. All observations that will lead to failure of an authority inspection.

The condition may affect the quality of the product, regulatory compliance. The condition violates GMP-rules and quality assurance practices. Action is recommended.Example: Not following own procedures and SOPs.

The condition may not affect the quality of the product, , regulatory compliance. The condition violates current GMP-rules.Example: Violation of formal aspects of documentation, e.g. missing sugnature in batch record

RRecommendation for quality, safety or efficiency improvement. No GMP violation.Example: Industry best practices, e.g. APIC How to do ICH Q7a - Document

Appendix D: Audit Report Template - 2 -

Serious

Major

Minor

Recommendations

Key for Classification of observations


Supported by

a sector group of

Presented by


Participation Voluntary basis Open to all API manufacturers, API

contract manufacturers, contract laboratories, API traders world-wide

Who can participate?


Supported by

a sector group of

Presented by


IMPORTANT:The auditee is free to use the audit

report without limitations.The audit report can not be received by(and/or bought from) APIC or Concept!

IMPORTANT:The auditee is free to use the audit

report without limitations.The audit report can not be received by(and/or bought from) APIC or Concept!

Supported by

a sector group of

Presented by


Prerequisites for conducting an audit:

• Educational background and professional experience• Participation in special Auditor

Training Courses Auditor Seminar Refresher Seminar

• Valid contract between auditor CONCEPT HEIDELBERG

• Certification as APIC Auditor

Qualified and certified Auditors


Supported by

a sector group of

Presented by


Educational Background and Experience

Educational Background and Experience

Participation in the Auditor Seminar

Participation in the Auditor Seminar

Database with Qualified APIC Auditors

Database with Qualified APIC Auditors

Participation in Refresher Seminar within 3 years after qualifying as APIC auditor Valid Contract with Concept Heidelberg

Participation in Refresher Seminar within 3 years after qualifying as APIC auditor Valid Contract with Concept Heidelberg

Selection for execution of

an audit

Selection for execution of

an audit

Database with Certified

APIC Auditors

Database with Certified

APIC Auditors

Interested PersonInterested Person

Qualified vs Certified Auditors


Important: Employees of authority and/orgovernment can’t be certified as APIC

Auditors because of conflict of interests !!

Important: Employees of authority and/orgovernment can’t be certified as APIC

Auditors because of conflict of interests !!

Supported by

a sector group of

Presented by


Practical Part


Auditors (First qualification seminars in January 2003):

- 40 qualified Auditors

- 13 certified Auditors

Conducted Audits so far (all of them were initiated by API manufacturers):

- 1 Pilot Audit conducted in September 2003

- 3 Audits in 2004

- further audits are being conducted in 2005

Supported by

a sector group of

Presented by


Critical Remarks


API manufacturers are not sure whether the pharmaceutical industry and the authorities will accept these audit reports for their supplier qualification.

The pharmaceutical companies on the other hand have their own audit policy and internal staff who is responsible for conducting supplier audits

More information is needed about the advantages of the APIC Audit Programme communicated to both, the pharmaceutical industry and the authorities.

Supported by

a sector group of

Presented by





• Discussion: Major Issues to look for in a GMP API Audit


Supported by

a sector group of

Presented by


Major Issues to look for in a GMP API Audit

Discussion

Question:

What are the major issues to look for in a GMP Audit of an API Manufacturer?

Supported by

a sector group of

Presented by



• API GMP Audits - Need for API GMP Audits - Need for StandardisationStandardisation API GMP Audits – Problems with ... API GMP Audits – Problems with ... APIC/CEFIC Guidance Dcoument APIC Auditing GuideAPIC/CEFIC Guidance Dcoument APIC Auditing Guide

• Solution: The APIC AUDIT ProgrammeSolution: The APIC AUDIT Programme Coordination by API Compliance InstituteCoordination by API Compliance Institute Steps in Managing an AuditSteps in Managing an Audit Qualified and Certified AuditorsQualified and Certified Auditors ConclusionsConclusions


Thank you for your attention.

Documents

Supported by a sector group of Presented by The APIC Audit Programme Thursday, 13 October 2005 Parallel Session The APIC Audit Programme presented by Dr