19.08.2014 |

LOGFILE No. 07/2014 - How to Master Crisis Situations

How to Master Crisis Situations

by Susanne Sailer

The challenges presented by the revised Chapter 8 of the EU GMP Guide


Dr. Ralf Büllesbach giving his talk at the PTS Conference in Düsseldorf

Last year, the European Commission closed the  public consultation on Chapter 8 of the EU GMP Guide, Part I (Complaints, Quality Defects and Product Recalls) and published commentaries on it. On the occasion of the GMP conference organised by the PTS Training Service in December of last year in Düsseldorf, Dr. Ralf Büllesbach (Bayer Pharma AG) presented his thoughts on the challenges posed by the practical implementation of the revised chapter.

Among other things, the participants learned what is likely to be overlooked or underestimated when operating procedures and templates for processing such cases are being implemented. Ralf Büllesbach: After all, dealing with complaints, quality defects and product recalls is virtually synonymous with mastering crises. Such crises emerge suddenly; no one is immune. There is no one in the pharmaceutical manufacturing sector who has not been confronted at some point with this complex set of issues.”

A person’s response to a crisis is defined first and foremost by the complexity of the environment (global enterprise, company network across several countries or a smaller, local business) and the role played by the individual (manufacturer, distributor or supplier).


Dr. Büllesbach outlined the reasons for the revision:

  • Risk management should permeate the entire scope of the environment governed by GMP. The principles of quality risk management should be incorporated not only into the investigation of quality defects or complaints, but also into decisions made on product recalls.
  • Consideration of the root causes of quality defects and complaints should be afforded greater importance. Appropriate preventive actions should be implemented to prevent a recurrence of the same issues. After all, it is no coincidence that inadequate and chaotic handling of complaints repeatedly finds its way into the list of top 10 complaints at the FDA.
  • Expectations and responsibilities should be clearly outlined when it comes to notifying the competent authorities about quality defects. Procedures determining when the authorities should be notified about quality defects and complaints must be coordinated with Directive 2003/94/EC.

Dr. Büllesbach then went into detail on individual passages of the revised chapter.


"...guard against a recurrence of the issue."

This means that the objective of CAPA (corrective and preventive actions) is to make certain that the same defects do not occur again. In any event, these actions are taken on the basis of a thorough root cause analysis. Ralf Büllesbach: “Only if the root causes have been identified and other potential causes ruled out or investigated is a CAPA programme feasible over time and capable of providing protection from recurrence of the problem. It is equally important to follow up by reviewing the effectiveness of a CAPA cycle.”

General information

"…record, investigate and review complaints including potential quality defects..."

Complaints must always be followed by an investigation. Incidentally, quality defects are not all that need to be investigated. For example, the investigation also covers defects in the application or the medication which occur due to misunderstood or unclear instructions. Moreover, all cases must be subjected to periodic reviews. Here, however, Dr. Büllesbach warns against excessive “data obsession”. The important thing is not that every single complaint should be scrutinised again. “However, with a certain number of cases it becomes possible to recognise signals and trends, to study types of defects in a structured manner and to compare them across multiple product groups. This review must always focus primarily on the risk to the patient, and the efficacy of the actions taken must be evaluated.”

"Principles of quality risk management should be applied..."

The following principle applies with reference to quality risk management: The sum of the effort, formalities and documentation in the risk management process should be proportionate to the risk. Utilisation of precious resources should commensurate with the risk involved. Each individual issue must therefore be assigned first of all to a risk class.

Classification of the risk should be scientifically based and should always be done while bearing in mind the potential risk to the patient. In the initial phase, this means gathering as much information as possible. Of course this requires intensive effort, but it is justified in light of the fact that critical adverse events are prevented in this way.

A second step calls for defining a schedule and an action plan for the various risk categories. A rule of thumb is: The higher the risk class, the shorter the processing time. Incidents with a high risk potential therefore require a high degree of commitment and rapid processing. The case should be thoroughly investigated and closed within seven days after receipt of the complaint. The targeted timeframe of 30 days maximum for all other issues cannot always be maintained. It is even quite possible to double this time, for instance if complaint samples have not yet been submitted.

Personnel and business structures

"If these persons do not include the Qualified Person….the latter should be made formally aware of…"

When it comes to mastering crises, the authorised persons and the organisation of workflows play a major role. The following points should be considered:

  • The Qualified Person should be included in the process if possible.
  • In situations in which complaints and quality defects are processed centrally within a company, the responsibilities and accountabilities should be clearly defined. Decisions cannot be made separately in each country.
  • The actual key to successful mastery of a crisis lies in interdisciplinary teams, since many things call for experience and practise in the various specialised fields
  • Sufficient numbers of employees must be available for contact with the authorities. Transparent communication backed by data is essential not only in dealing with the authorities, but also within the company. Openness is imperative in dealing with complaints, quality defects and product recalls. Understating and rationalising problems do not lead to success.

Investigation and decision-making

The guideline contains a detailed section on investigations of complaints and possible quality defects. Internal rules, for instance, must stipulate

  • who defines the scope of an investigation,
  • when a batch record review is sufficient and
  • who examines retention samples.

The following questions relate to samples:

  • How often must samples be requested?
  • Are operators endangered?
  • When may samples be disposed of?

Speed and professional competence above all else are essential for the investigations. Clear strategies are helpful here, as is a readily available, interdisciplinary team empowered with the necessary authorisations. A contact person for the competent authority should be appointed from the very beginning. The authorities network closely within the EU; the catchphrase is “Rapid Alert”. Preparations for informing the public should also be in place in case of dire emergency.

Product recalls and other risk-mitigating actions

"Any retrieval of product from the distribution network as a result of a quality defect should be regarded and managed as a recall."

The term “batch traceability” is often mentioned in this connection, since it should be possible to trace batches quickly for product recalls. Written procedures are required for this. Ralf Büllesbach: “The effectiveness of the processes intended for high-risk products should be verified and drilled repeatedly with mock recalls.”

What can go wrong?

Here are some of the hazards and stumbling blocks lying in wait for those who deal with complaints, quality defects and product recalls:

  • A laissez-faire attitude or arrogance is dangerous at any time in the process. Every single complaint must be completely and comprehensively processed. Even the 150th, presumably unfounded complaint from a customer must be taken seriously.
  • Time limits are not kept or not monitored.
  • Individual decision-makers have too much influence and other areas (e.g. production, QP, PhV, QA) are not included on equal footing.
  • There was no initial, effective risk management.
  • The authorities were only inadequately informed or not informed at all.
  • Decision-making processes are slow due to protracted procedures, lack of experience or fear of possible repercussions.

Dr. Büllesbach concluded with an appeal: “The pharmaceutical industry is notorious for not wanting to hear much at all from customers. Unfortunately, this pushes the positive effect of complaint management much too far into the background. As in other branches of industry, this negative view of complaint management must change. The important thing is to find something positive in the feedback from consumers.”

Sources of information

GMP Conference, PTS Training Service, 3rd/4th December 2013, Düsseldorf

Draft of Chapter 8 “Complaints and Product Recalls“ of the EU-GMP Guide


Susanne Sailer
Maas & Peither AG, GMP-Publishing