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ECA´s new GMP-Auditor Guide

A team of experts have developed a new ECA Good Practice Guide "ECA Code of Practice for GMP Auditors". The guide considers feedback from GMP inspectors, the pharmaceutical industry and suppliers as well as practical experiences from real project cases.

In the course of establishing the new ECA Working Group and moving towards becoming an Association, it became apparent that ECA wanted to produce a guide for its members.

The group decided early on that they would focus on the most important chapters first, rather than waiting until a full guide was produced. This way the group could shorten the time to delivery and also has the opportunity to collect feedback and improve content. The first versions of the chapters have different formats and styles as different volunteer teams were involved in their creation. In the future, the group will work on further standardisation and add additional chapters. Members of the new GMP-Auditor Association will get free access to an online version, participants of this GMPAuditor Forum will also receive a hard copy of the first version.

Here you can find an excerpt from the guide, the chapter on selfinspection, written by Dr Felix Kern:

1. Background

Self-inspections are an independent, objective assurance and consulting activity designed to add value and improve an organisation's operations. Self-inspections are not only mandatory (EUGMP Guideline Chapter 9), the results and observations from self-inspections provide evidence of the effectiveness of the quality system in place. Self-inspection is a tool to assess and continuously improve the suitability and condition of systems, processes, equipment and premises.

But self-inspections have their own character and require special planning, implementation and follow-up. They are an integral part of the GMP- and quality system at a pharmaceutical manufacturing and testing site.

2. Regulatory Requirements

Regulations for self-inspections and internal audits are a little bit different in the US and the EU. For example, if you delete your internal audit report after the CAPA plan was closed, then you would be compliant with the FDA regulations, but not with the regulations in the EU. It is important to realise that the US cGMP regulations (21 CFR Parts 210 and 211) do not describe specifically a requirement to conduct and keep records of an internal quality assurance audit, which is not the case with the EU-GMP guideline. Besides the American and the European regulations more information about self-inspections can be found in the WHO requirements and in the PIC/S guidelines.

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QP pre-course Session: Interpersonal and Soft Skills for the QP

Following the EU-GMP Guideline Chapter 9, audits should be carried out to monitor the implementation and the compliance with GMP principles. All areas of GMP are included in the scope of such audits. This is pretty much like an external audit of a third-party manufacturer or a supplier. But there are some special aspects to consider. The auditor can be a member of the team that is audited, but it is also possible that an external auditor, not being part of the team, carries out such an audit.

3. Organisation

3.1. Planning Phase

Self-inspections should be pre-arranged and planned in an inspection program. For preparation, the organisation should define the overall process in advance, leaving the specific key aspects to be detailed during the self-inspection. A pre-prepared checklist (questionnaire) may be used allowing the auditors to ask appropriate questions relevant to the operations (see chapter 1.7). A formal approval demonstrates management commitment to the completion of each self-inspection.

In the planning phase the area in scope should be clearly defined:

  • the inspection team is appointed (see 9.3)
  • the topics to be covered are defined
  • a possible and dedicated checklist is created
  • departments and persons involved are informed

Areas to be covered and to what extend depends can depend on:

  • the size of the company
  • number of different products and processes
  • changes in the organization
  • changes in the processes

3.2. Implementation Phase

A self-inspection performed by the Site Quality Unit Function represents an important opportunity to check if the QMS has been implemented successfully:

a) In place - each GMP related operation and activity are described in controlled documentation, and
b) In use - each GMP related operation and activity are physically performed in-line with the content and description in the relevant controlled documentation.

The status of the audited area is recorded appropriately.

3.3. Wrap-up

Phase Deficiencies identified during the self-inspection are reported as defined in the procedure. Any recommendation corrections can also be discussed at this meeting. If potentially critical non-compliances are identified, management must be informed immediately and appropriate action taken.

3.4. Formal Report

A written report should be prepared and submitted to the auditees, this should include a list of deficiencies identified and the expected timelines for a CAPA plan.

3.5. Follow-up Phase

It is expected that the recipient of the self-inspection prepares a CAPA-plan to address the issues reported and define actions. The self-inspection team should review this CAPA plan and depending on the nature of the deficiencies decide if a dedicated follow-up inspection is needed.

The auditee is responsible for tracking the deficiencies. The response to the findings should follow a formal process of:

  • root cause analysis
  • impact analysis
  • preventive actions
  • corrective actions
  • effectiveness review and timing objectives

The respective Quality Unit should review this information and agree or offer an alternative approach. The Quality Unit assist the auditees in working on the task and defined actions to ensure an effective process which meets GMP requirements.

Findings, defined actions and follow-up should be reviewed by Senior Management on a regular base. The role of the Quality Unit is to ensure that corrective actions are addressed to prevent future occurrences. For this, specific items should be cited, and a regular retrospective review of any impact must be performed. The appropriate Management Review activity should examine the timely completion of self-inspections, timely report issue and the on-time completion of CAPAs accordingly.

3.6. Frequency

The GMP guidelines do not specify how often self-inspections should be carried out. Chapter 9 of the EU-GMP Guide defines that they "should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance." What is important is that processes follow a predefined schedule and that the frequency is defined following a risk-based approach. An appropriate period should than be chosen depending on products and processes.

4. Inspection Team

An inspection team for a self-inspection can have more roles than in an external audit: besides the auditor, they can also be consultant. An open discussion between auditor/ auditee is recommended. To ensure that members of the team are not auditing their own areas of responsibility and their own work, it is important to carefully compose each team to be independent.

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GMP and Quality Requirements for Radiopharmaceuticals

This means that as an auditor the team plans and executes the audit and the reporting in a neutral and direct manner. They should discover things that are non-compliant with GMP regulations or might lead to a non-conformance. On the other hand, the team can also provide advice to the managers and operators of the audited area. This support in solving problems wherever possible should in general be independent of the auditor role, but might be needed during, but also after the self-inspection to discuss necessary actions which should be carried out to improve the system. For this purpose, the audit team needs to be aligned with the management expectations and must be as independent as possible.

Self-inspections can be carried out by designated employees from other departments with adequate knowledge and experiences eligible as auditors. In general, the Quality Unit is accountable for planning and performing of the audited area. Depending on the size of the company there may be designated Quality Unit functions responsible for external audits and self-inspections. The Quality Unit might be inspected by other departments, other Quality Units of the same company or external auditors. It is also possible to involve personnel from other departments in self-inspections, for example, the Head of Manufacturing can be involved in the self-inspection of the quality control laboratories and vice versa the Head of Quality Control can be part of the self-inspection team for the manufacturing areas.

Also external experts can carry out a self-inspection. Here, sufficient objectivity and is assured. 

5. Topics and Areas in Scope

All areas which are covered by GMP regulations can have a potential impact on the quality of the product. These processes should be in the scope of self-inspections, e.g. maintenance of buildings and facilities, calibration systems, raw materials, packaging materials, intermediate and finished products, validation and qualification progammes, documentation systems, cleaning and hygiene systems, data integrity, change control, deviation and CAPA systems and manufacturing and quality control areas.

This might include for example include:

  • The Batch Release Process
  • Training Programs
  • Qualification and Validation System
  • Document Management and Control
  • Facilities and equipment
  • Laboratories systems
  • Packaging and labelling
  • Production and material control system

The checks during the self-inspection should not be limited to the review of the company's current GMP approach and processes, but should also include a follow-up of observations and actions defined from previous self-inspections.
It is also important to include in the scope a review of the processes used for integrating regulatory and legal developments and changes into the pharmaceutical quality and manufacturing system, as well as consideration of most recent technologies. This includes identification and listing of all the relevant changes in an early stage, as well as its implementation in an appropriate manner.
In addition, the function and performance of the Quality Unit should be reviewed, this may include an assessment of quality oversight.

6. Authority Inspections and Self-Inspections

Self-inspections are also a perfect tool to prepare a company for regulatory inspections by the authorities.
On the other hand, authorities might check the self-inspection system/ program for its compliance with the regulations (e.g. EUGMP). It might be checked if a self-inspection plan is available and if the self-inspections are carried out following the plan.
The documentation of the self-inspection system should be organised in a way that there are documents confirming that the selfinspections were carried out, e.g. via an approval page or via the time schedule, and documents related to the outcome of the selfinspection, e.g. the report or the CAPA-plan.


About the Author
Dr Felix Kern is a pharmacist and Head of Production at Merck KGaA in Darmstadt.


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