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LOGFILE No. 37/2016 - Preparing for the EU GMP Inspection


An excerpt from the GMP Focus PDF Download Preparing for the EU GMP Inspection

by Dr. Christian Gausepohl and Max Lazar


Article 14 of the EU GMP Directive 91/356/EEC and Chapter 9 Packaging and Identification Labelling of APIs and Intermediates of the EU GMP Guideline indicate that self-inspection should be considered as part of the quality assurance system. The manufacturer should monitor itself at regular intervals to check whether the rules of good manufacturing practice are being applied and adhered to. This applies to all practical conditions on-site and the corresponding documentation. It should also make proposals for remedial actions, in the event that they are required. In the USA, self-inspections or self-audits have been considered a favorable part of a sound Quality System.

Carrying out the self-inspection

According to Chapter 9.1 General of the EU GMP Guideline, self-inspections should examine personnel matters, premises, equipment, documentation, production, quality control, and distribution of the medicinal or drug products, arrangements for dealing with complaints and recalls, and self-inspection.

Self-inspections should be pre-arranged and laid down in the form of an inspection program. In preparation, the rough process should be defined in advance. This means that specific key aspects are detailed. Ideally, checklists should be compiled (questionnaires) so the inspectors can ask each question successively. The advantage of this is that follow-up inspections carried out by other inspection teams will be more or less comparable.


Figure 1 Process for a self-inspection

The EU GMP Guideline does not mention the frequency of self-inspections. It is, however, advisable to choose shorter inspection intervals initially (every three months). Later, when sufficient experience is available, the interval can be extended. Naturally, critical areas (e.g. operations with the exposed product) and procedures (e.g. those with narrow acceptance criteria) should be inspected more often than areas and procedures that are easily controlled. Negative developments observed during trend analysis of monitoring, for example, should be counteracted by investigative measures in as early a phase as possible. The setting of priorities must also be transparent to the supervisory authorities.

The self-inspection procedure should be detailed in an instruction and take into consideration the points outlined in Figure 2.

The reason for a self-inspection may be routine scheduling or there may be a precise cause, e.g. OOS results caused by manufacturing errors. In the event of a deviation, it is advisable to take this as the “reason” for analyzing procedures and processes. Self-inspections are often used to prepare for inspection by the authorities.

Designated competent person(s) from the company should be assigned to conduct the self-inspection. They should be independent of the subject of the inspection. The EU GMP Guideline explicitly states that it is useful for external experts, e.g. staff from other facilities or consultants, to participate. It is obvious that if the inspectors are independent, objectivity and the significance of inspections are increased. It is, however, not compulsory to call on external experts. Generally, companies create inspection teams using representatives from different areas (e.g. manufacturing, quality control, engineering, development, microbiology, and warehousing) so that there is a broad base of knowledge and experience for carrying out the inspection. The WHO GMP Guideline talks about “self-inspection teams”. From the point of view of the practical aspect of carrying out the inspection, it is advisable to form groups of 2–4 persons.


Figure 2 Self-inspection procedure

Although it is not explicitly required, organizing and carrying out self-inspections can be considered as an important task for quality assurance. The extent to which these inspections are only carried out by staff from this area depends on the size and structure of the quality assurance division. In smaller and mediumsized companies it is advisable to form teams of inspectors recruited from quality assurance, production management, quality control management and individual departments.


The GMP Focus PDF-Download Preparing for the EU GMP Inspection touches all the bases:

  • What types of inspections EU drug regulators conduct
  • The qualifications of inspectors
  • The formula used by regulators for determining priority order and frequency of individual inspections
  • Sample inspection documentation
  • Contents of an inspection report
  • Self-inspection checklist
  • And much more


Dr. Christian Gausepohl
Rottendorf Pharma GmbH

Max S. Lazar
FDA Regulatory Compliance Consulting

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