Updates from the ECA Interest Groups
Every quarter the ECA’s Interest and Working Groups inform about their accomplishments and current activities. In the following you’ll find their third quarter 2018 report.
European QP Association - Activities
The Association's IMP Group sent summarised comments to EMA on the draft of the Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice. The public consultation started end of May.
On 28/29 August, a joint ECA/EQPA conference was held in Chicago, USA. The objective was to share information and experience and to discuss the critical areas of European GMPs and the QP’s daily work.
The IMP Working Group compiled a survey on the “order” as referenced in Annex 13 section 8 and in the Detailed Commission Guidelines section 5.2. The Group thinks that the guidance does not provide the industry with clear instructions. Aim of the survey was to get a benchmark of current industry practice and to discuss this at the IMP QP Pre-conference in November. The Working Group was looking for only one completed survey per company to get consolidated Information.
The EQPA Chairman joined the EMA Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human and veterinary medicinal products (24 September 2018). The meeting also provided clarification to questions QPs might have, for example:
- Only with a signed withdrawal agreement the transition agreement could be signed and become effective
- without transition agreement full application of laws to a 3rd country
- with transition agreement QP certification and testing arrangements could continue as before until end of transition period (31 December 2020)
- GMP certificates are in general legally not necessary for QP certification if the QP has assessed the risk as satisfactory and is convinced of appropriate GMP. If GMP certificates issued by UK may become invalid the manufacturer and QP may have to re-assess the Situation.
Pharmaceutical Microbiology Working Group - Activities
Work on the Q&A paper on culture media progressed – first results were presented. The final paper is planned to be ready by end of 2018.
Analytical Quality Control Group – Activities
The Group finalised the first final version of its Analytical Procedure Lifecycle Management (APLM) Guideline. The 80 pages document was signed by Dr Christopher Burgess on behalf of the Expert Drafting Group and by Dr Phil Nethercote for the technical review on behalf of the ECA Analytical QC Group.
The new Guideline was distributed to a selected audience (FDA, USP, EFPIA, etc.) in August and September 2018.
Launch of the new APLM Guideline was at the PharmaLab Congress on 20/21 November in Düsseldorf – where delegates of the APLM Conference as part of the Congress received a free copy.
The next face-to-face Board meeting was scheduled at the PharmaLab Congress. There the following topics were on the agenda:
- Review progress on workplan 2018/2019
- APLM Guideline feed back and preparation for version 2
- ICH Q2(R1) and USP <1220> progress following meeting in Rockville 26th and 26th September 2018
- Strategy and structure for Sampling and Sample Management Guideline for 2019.
A survey about the awareness of the concept of the Analytical Procedure Lifecycle Management (APLM) Approach and the use and acceptance of Quality by Design for analytical methods was completed at the end of July 2018. Feedback was provided by 86 people. The results of this survey were presented at the PharmaLab APLM Workshop on 20 November 2018. Results will also be posted in the members' area of the Website.
Validation Group - Activities
An official Draft 01 of a Modern Qualification Good Practice Guide was published at the Modern Qualification Conference in September.
A survey on Modern Qualification was conducted in August 2018. The results were presented via ECA´s newsletter and at the Modern Qualification Conference in September.
European GDP Association - Activities
The Code of Practice for the RP in GDP is being revised.
Two new Q&A sections covering Chapter 2 and Chapter 3 of the EU Good Distribution Practice Guide were published on the website.
Two new Q&A sections covering Chapter 2 and Chapter 3 of the EU Good Distribution Practice Guide were published on the Website.
The final GDP Guidance on Interpretation and Implementation was published as a joint publication of the ECA Foundation and the Pharmaceutical Quality Group (PQG). This document and its chapters are built around the format and text of the 2013 EU-GDP guidelines, providing a sound basis for the implementation and maintenance of a GDP quality system with clear responsibilities and processes and the application of risk management principles. It should be of benefit to all involved in GDP activities for initial training, continuing professional development and as a reference source or audit tool. GDP Association members are entitled to a 30% discount when purchasing hard copies of the ECA/PQG Guide – information is available in the website members' area.
An article on “GDP: the growing issue of theft” was drafted for external publication.
Visual Inspection Group - Activities
The next board meeting was scheduled in October 2018 before the ECA conference ‘Particles in Parenterals’.
The finalisation of the Annex 1 will determine whether the ECA Visual Inspection Guidance document hast to be updated or not.
ATMP Group - Activities
An industry/authorities expert workshop and GMP for ATMP education course is in the planning and scheduled for June 2019.
The provisions of the new European GMP guideline specific to ATMPs and valid since the end of May 2018 have been discussed intensively among members of the authorities, academia and industry involved in the development and production of ATMPs. Thus the ATMP Group set up a survey. Results are supposed to be available in Q4.
The Blood & Biologics Newsletter was expanded and now also comprises ATMP News.
IT Compliance Group - Activities
Preparations started for a DI Toolbox. First documents were reviewed by the board.
A 2-days DI Conference will be part of the Pharma Congress 2019 – lectures will focus on manufacturing and Engineering.
The IT Compliance Group will possibly cover DI topics in the future and may therefore be renamed.