The Professional Use of Auditing Techniques Requires Exercise
Some of us feel uncomfortable when talking about audits. And indeed, a number of audits lack of efficiency, miss systematic approaches, demonstrate low knowledge of GMP by the auditors and show that auditors are overstrained by leading and maneuvering through an audit. Together with the vast increasing number of audits, auditees become stressed and the potential advantages of audits is often getting lost.
And with all the ‘audit stress’ it might become forgotten why audits are required at all.
EU Regulatory Framework for Conducting Audits
To verify the GMP status internally and externally (e.g. suppliers) auditing has been made an obligation within the EU and is laid down in EU GMP Part I, Chapter 2 (Personnel), section 1.4 (xvii), Chapter 7 (Outsourced Activities), section 7.1.1 and Chapter 9 (Self Inspection) (1). The GMP compliance of API manufacturers has to be confirmed in writing in a Qualified Person (QP) declaration that has to be provided as Annex 5.22 of the EU Application Form for a marketing authorization application (2).
Audit Guidelines from Industry Organizations
Unfortunately, there are no ‘official’ guidelines in place for conducting audits in the pharmaceutical field as it is known in other areas like finance or aerospace.
Nevertheless there are industry organisations that provide guidelines such as the Active Pharmaceutical Ingredients Committee (APIC) (3) or the Europe Auditing Guide for Excipients (IPEC) (4).
Auditing Skills and Techniques – Prerequisite for a Successful Audit
We need to be aware that an auditor can’t see everything during an audit; he is conducting a spot check of the environment of the auditee. On the other hand, audits are very helpful for assessing a company’s quality system, compliance with regulations and identifying areas for improvement. It is a comparison of what is written down to what is in place. An auditor’s task is to identify the differences and describe the observations in an understandable, objective manner. Observations should be discussed with the auditee in mutual respect and in a constructive atmosphere. It is not the auditor’s task to impose corrective actions. These have to be initiated and approved by the responsible management of the auditee.
Conducting a good audit needs more than solid knowledge of the GMP regulations. It also requires the auditor’s empathy towards the auditee. As the auditor takes up the role of the moderator, he must be capable of conversation skills. Therefore, successful auditing comprises skills in terms of knowledge about regulations and audit techniques.
The professional use of audit techniques requires exercise and practice
The purpose of this workshop is to provide expert guidance for conducting effective audits and to share ”best practices” of performing audits. It is addressed to all those who are involved in conducting and hosting audits and should make both parties (auditee and auditors) aware of potential conflicts and concerns and how to avoid/overcome them. It aims to provide awareness of the importance of audits in order to ensure a successful outcome.
Auditing is a powerful tool in the hands of experts but potentially devastating in the hands of inexperienced auditors. Auditing requires professionalism.
Exercise your Audit Skills and Audit Techniques in a Practical training course ‘Auditing’ on 17 September 2019
On 17 September 2019 you will have an opportunity to train your auditing skills during our Phact workshop in CH-Reinach /BL (near Basel). The workshop is limited to 5 participants.
Workshop organizational details and programme available at
APIC Active Pharmaceutical Ingredients Committee
CEFIC The European Chemical Industry Council
EBE European Biopharmaceutical Enterprises
EU European Union
GMP Good manufacturing practice
IPEC International Pharmaceutical Excipients Council
ISPE International Society of Pharmaceutical Engineers
PDA Parenteral Drug Association
QP Qualified Person
- EudraLex Volume 4 Good manufacturing practice (GMP) Guidelines. Part I: Basic Requirements for Medicinal Products.
- Chapter 2. Personnel
- Chapter 7. Outsourced activities.
- Chapter 9. Self Inspection.
- Online. https://ec.europa.eu/health/documents/eudralex/vol-4_en; accessed 5 August, 2019.
- European Commission Health and Food Safety Directorate-Generale. Notice to Applicants: Medicinal Products for Human Use. Volume 2B. Module 1.2: Administrative information Application form. February 2018. Revision 13.
- Online: http://esubmission.ema.europa.eu/eaf/eAF_188.8.131.52/maa_human_v184.108.40.206.pdf; accessed 5 August 2019.
- APIC Auditing Guide and Annexes 1 to 3.
- Online: https://www.apic.cefic.org/publications.html; accessed 5 August 2019.
- The IPEC-POQ Good Manufacturing Practices Audit Guideline. 2008.
- Online: https://www.ipec-europe.org/guidelines.html; accessed 5 August 2019.