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Editorial | Open Access | Published ?

PHSS News - March 2020

Dear Readers

2020 is going to be a significantly challenging year for us all. Bringing uncertainty in these unprecedented times. We have made necessary changes to our programme of events, either postponing to later in the year or moving out into 2021. The Committee will continue to meet throughout the year albeit virtually. Our focus on providing practical guidance continues, and is being proactively led by James Drinkwater. We are also now seeing more activity and engagement with Annex 1, for more information please visit the PHSS website.

I am pleased to see the Journal going from strength to strength now moving to the 3rd edition of the online platform, supported by our authors and dedication from our editor in Chief Kay O’Hagan. Thank you also to Tamsin Marshall for behind the scenes hard work to deliver the publication.

Please stay safe in the challenging times.

Jenni Tranter, Chair of PHSS – Pharmaceutical & Healthcare Sciences Society.


EJPPS Annex 1 PHSS Commenting report

On behalf of the PHSS Annex 1 focus group Co-Leads James Drinkwater & Di Morris

The PHSS are one of the official commenting platforms appointed by the European Commission in the current Annex 1 version 12 Targeted Consultation process that requires comments submitted by 20 May 2020. Targeting is used in the context of comments submitted through targeted platforms, there are 11 appointed groups including; A3P, AESGP, Animal health Europe, ECA/EQPA, EFPIA, EIPG, ISPE, Medicines for Europe, PDA, PHSS, Vaccines Europe.

Targeting is also set around clauses of Annex 1 that were of concern in the last public Stakeholder consultation and/or have been significantly changed. There is an opportunity to provide other significant comments but these are encouraged as not to be repeats of previous comments. The PDA are facilitating a Co-ordination initiative, via a number of Tcon meetings between the commenting platforms to share and discuss concerns on Version 12 of Annex 1 so as far as possible the commenting process is aligned. At the outset in the review of Version 12 of Annex 1 under the consultation process the PHSS completed a ‘Contrast and Compare’ process that considered what changes were made from the 2017 Public Stakeholder version to the current 2020 Annex 1 version 12 – this process indicated significant changes between the versions.

Versions 2017 vs 2020 Comparison outcome:

  • Not one single line of text aligned between drafts 2017 and 2020 indicating substantial editing of the complete document.

  • Some good guidance in the 2017 version is removed in version 12 without clear justification.

  • Clauses were moved from section to section.

  • Only limited sections and clauses of version 12 were considered open in the targeted consultation and these by no means reflect to full changes of Version 12 and possible changes still required to the full Annex to add clarity.

  • The complete document would benefit a professional editorial process to add clarity in language, terms of expression and continuity of terms – there has been limited improvement in this respect.

  • Glossary is ‘Guidance by another name’. Some Glossary provides poor clarity as guidance when no other detail is provided in the main Annex 1 text.

The PHSS Annex 1 focus group considers that some Annex 1 sections have a lack of clarity and as a result would benefit substantial editing and not just simple text line changes. In particular; sections that include details on Environmental classification, Qualification (Environmental and APS), Routine monitoring (EM/Process), re-qualification should be considered as a linked step wise process and not individually. There seems limited apparent connection of these key steps from classification/qualification through to production operations and a specified state of control. Also guidance on Barrier technologies confuses and makes little differentiation between Isolators and RABS. In discussion with other commenting platforms all are concerned by the lack of balance between high level/principle guidance and prescriptive guidance that provides both challenges in clarity and restriction in real advances that benefit the patient via improved use of innovation, different ways of working and improved sterility assurance all delivered with improved efficiency. Despite the encouragement of use of innovation and references to following QRM principles the prescriptive text restrictions may limit their application.

PHSS Strategy on Annex 1 version 12 Commenting

The PHSS have appointed an Annex 1 commenting focus group which includes collaboration partners: PQG, JPAG and R3 Nordic, that will submit commenting through the PHSS platform. As it is necessary to comment on the full Annex 1 version 12 and not just the limited sections defined in the targeted consultation the PHSS have developed a strategy how to present this position to the EC, whilst still following the current procedure so comments can be considered to be valid. The PHSS believe it is important to use a Covering letter to fully share concerns and justify the use of ‘Other significant comments’ for the remaining sections of Annex 1 where comments are also considered significant and not just repeat comments from the 2017 consultation process.

The following PHSS commenting steps are in progress:

  1. Review incoming comments taking into account; Comments (concerns), suggested alternate text and justification – some have submitted all three and others just raised concerns - all are taken into consideration.

  2. Collate comments in the Excel spread sheet format required for the final submission to the EC together with a covering letter.

    1. A covering letter will be prepared that explains the PHSS main concerns with Version12 of Annex 1 (including general points like need for an editorial process), what the PHSS commenting process entailed including reference to collaboration partners. The covering letter will provide an explanation of the PHSS comment submission form and formatting in TAB sections.

    2. It has been recommended by the PHSS that the full Annex1 appointed commenting platform prepare one co-ordinated ‘All commenting groups’ Covering letter. Such a letter would present the major concerns of version 12 and the need to edit before release and potential implementation that may impact the Pharma/ Biopharma industries, ATMP and Healthcare sectors and regulators alike if errors and lack of clarity persist.

    3. To make the commenting process more manageable the PHSS Annex 1 focus group have created section or topic specific Excel spread sheet Tabs building from the Consultation pages.

    4. The merged format of the EC Excel sheet only accepts new text as underlined and deleted text as crossed through.

    5. Rather than line by line text references the PHSS have entered ‘readable flowing text’ in text blocks (para’s/ clauses) that relate to lines ‘from and until’ as bracketed sections of Version 12 to facilitate more significant change in wording. • Where possible and without compromising clarity the new text ‘blocks’ will include written text lines from version 12 to link alternative text.

    6. Additional Other Significant Comments (OSC) tabs will be created in the Excel sheet to cover areas outside the targeted consultation clauses. OSC comment Excel Tab headings will be given an addition sub heading that is topic specific e.g. OSC_PUPSIT to lead the reader into a clear concise page of comments so other significant comments are not mixed and confused together or lost in a long list of main comments which may be given less priority. The OCS Tab pages will follow the same format as for main commenting.

  3. Prepare consensus alternative text in sub groups when clause/section editing is considered to require significant changes. Currently the PHSS have identified two Sub-groups a) Classification and Qualification – to include connection to process monitoring b) Barrier Technology- to appropriately differentiate Isolators and RABS and key practices of set-up for process operations.

  4. Share PHSS comments including alternative consensus text with the PHSS membership and collaboration partners to provide a chance (one week) for feedback before submission of PHSS Comments to the EC before the 20 May deadline for closing the Targeted consultation.

According to the EC the next release version of Annex 1 will be ready for implementation following a set period within which further comments may be made but will not be reflected in another version and only taken into consideration during implementation. So this Targeted Consultation process is really important for all Stakeholders and we encourage all to follow this process through the PHSS or one of the other appointed commenting platforms.

The PHSS wish to thank all those involved in the team effort on this important Annex 1 commenting process.


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