Guides & Documents

Here is an overview of the documents and guides elaborated:

  • ECA Equipment Design Guide
    The purpose of the ECA's GMP Equipment Design Guide is to illustrate the generally applicable requirements for the design of equipment and to explain how the connection between design and the statement “produced in compliance with GMP” can be made.

    Get your free copy of the document

  • Contamination Control Strategy Task Force
    ECA´s Task Force on Contamination Control Strategy prepared a Guideline document that supports the user in creating a CCS, building up the documentation (comparable to a Site Master File – SMF) and thereby fulfilling the requirements of EU GMP Annex 1.

    ECA Task Force on Contamination Control Strategy - Guide How to Develop and Document a Contamination Conrtrol Strategy

  • ECA Good Practice Guide "Code of Practice for QPs – Duties and Responsibilities for Qualified Persons in the EU" - Version 8.0.
    The EU Directives and the EU Guide to GMP define some detailed requirements to be met by the Qualified Person (QP). These requirements have been extracted from the relevant documents and are summarized in a Good Practice Guide developed by the European QP Association.

    To the European QP Association Website

  • Pharmaceutical Microbiology Group
    The group was founded as Rapid Microbiological Methods (RMM) Working Group on 7 June 2006. It reviewed the current situation of RMM in Europe. In the following years it supported group members with current information about the development, implementation and validation of RMM. Today the scope of the activity is broader. Therefore the group was renamed to Pharmaceutical Microbiology Group. Its paper/guidance document is available for download if you register for the Group.

    ECA Guidelines for the Evaluation and Investigation of Microbiological Deviations

  • Analytical Quality Control Group
    The ECA Working Group on Analytical Quality Control was founded in 2010 in order to generate a harmonised SOP on managing analytical deviations within the laboratory including OOS, OOE and OOT results.

    Analytical QC Group Guidances & SOPs

  • Validation Group
    The ECA was one of the first organisations which published a Good Practice Guide regarding the new FDA Process Validation Guidance. With the revision of the Annex 15 also this Good Practice Guide has to be updated. As 1st revision the guide contains on one hand the main elements of the new validation approaches ("what to do"). On the other hand, it also serves as a supporting guide for the implementation ("how to do").

    Validation Group Guidance Documents

  • GDP Association

    The GDP Interpretation Guide was published jointly by the ECA Foundation GDP Association and the Pharmaceutical Quality Group (PQG). Its intention is to help colleagues in industry with the implementation of the EU GDP Guideline. The Guide is available for download if you register for the Association.

    ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribution Practice & ECA/PQG Guidance on the Interpretation and Implementation of European Good Distribuition Practice for Active Substances

    ECA Code of Practice for The Responsible Person for GDP
  • Visual Inspection Group
    This group’s best-practice-paper aims at highlighting best practices for carrying out 100 % visual inspection of medicinal products for parenteral use in the pharmaceutical industry.

    Visual Inspection Group Guidance Documents & Best Practice Paper

  • Data Integrity & IT Compliance Group
    The best-practice-paper was originally developed by the ECA Data Integrity & IT Compliance Group’s Advisory Board. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues.

    Data Integrity & IT Compliance Group Checklists & SOPs
  • Data Integrity Task Force
    The ECA Guidance Document covers - among others - the roles and responsibilities of Corporate and Senior Management in Data Governance as well as the necessary Policies, Procedures and Processes. It further provides information on establishing criteria for Data Integrity and security of records based on ALCOA+Principles and on Auditing for Data Integrity and security of records.

    ECA Guidance Document - Data Governance and Data Integrity for GMP Regulated Facilities

  • Cannabis Working Group
    Searching for answers to GMP and other regulatory questions is a time-consuming activity. The ECA Cannabis Working Group’s document – available exclusively at the respective events – is therefore intended to provide a source of information, summarizing GMP and other regulatory information and documents currently available on a global level. In addition, it provides useful comments and an Annex with further information. It is the intention of ECA's Cannabis Working Group to update this comprehensive collection regularly and to add new information on regulations and guidelines once they are available.

  • Annex 1 Task Force
    Please find more information on the first comments from the specifically established Annex 1 Task Force as well as on the comments in the second targeted consultation.

    Joint letter from the ECA Foundation, European QP Association and Annex 1 Task Force in the second targeted consultation and Comments