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20 August 2020   (0 Comments - view/add)
Annex 1 Version 12 Commenting Submitted 20th July 2020 »
On the 20th July 2020, PHSS along with 11 other Associations and Societies submitted their comments, this has been an exte...
16 July 2020   (0 Comments - view/add)
Impact Statement Australian Therapeutic Goods Administration (TGA) – Remote inspections »
Background Following the suspension of on-site inspections during the COVID -19 pandemic, TGA developed new arrangements...
13 July 2020   (1 Comment - view/add)
Annex 1 Version 12 Comments have been submitted »
PHSS submitted Annex 1 Version 12 Comments to EMA   The PHSS would like to extend thanks to James Drinkwater (F...
08 June 2020
PHSS Impact Statement - Delivery of Medical Supplies /Pharmaceuticals by Drone within the UK »
Impact Statement –  Delivery of Medical Supplies /Pharmaceuticals by Drone within the UK – is this a realistic app...
28 February 2020   (0 Comments - view/add)
Impact Statement MHRA Recruitment Feb 2020 »
Within our industry we need to be very appreciative of our UK Regulator and particularly it’s inspectorate branch. They ha...
21 February 2020
Breaking News! Annex 1 Version 12 released for 3 month consultation process »
  Annex 1 Version 12   The European Commission (EC) have started a targeted consultation p...
04 December 2019
Impact Statement–Risk of nitrosamines being present in medicinal products »
Impact Statement – Risk of nitrosamines being present in medicinal products   Background...
03 September 2019   (0 Comments - view/add)
EJPPS Volume 24 Issue 2 »
Last printed edition available to download. New online edition to be available shortly.   Please find t...
14 May 2019
Lessons from the Sartan incidents – Impact Statement »
Impact Statement Lessons from the Sartan incidents Background   In the summer of 2018, a U.S. dru...
17 April 2019
Obituary - Stephen Fairchild. PHSS would like to say farewell. »
    Stephen B Fairchild 1943 – 2019   Steve passed away in February after a long...
16 December 2018
PHSS Clarity of GMP Guidance - Assurance of Sterility Dec 2018 »
PHSS Clarity of GMP - Guidance Note 1   PHSS are pleased to announce the newly available PHSS Clarity on...
17 October 2018
Time is running out! Vote now for Management Committee Members 2018 »
    You only have 2 days left to vote!   Make your vote count! &nb...
07 September 2018
Impact Statement - No deal scenario »
Impact Statement   “BREXIT” – UK government’s preparations for a March 2019 ‘no deal’ scen...
12 July 2018   (0 Comments - view/add)
PHSS July 2018 Regulatory Update: Shortages of Medicines; Q12 Technical and Regulatory Consideration »
  PHSS Regulatory Update July 2018   During the last 4 weeks there have been a number of developments...
09 July 2018   (0 Comments - view/add)
PHSS Impact Statement - FMD »
Impact Statement - Falsified Medicines Directive July 2018 As we should all know the implementation of the falsified...
29 May 2018   (0 Comments - view/add)
Summary status document from the EU Commission »
Following our recent Brexit impact statement here is a 'Summary status document from the EU Commission'.   It c...
14 May 2018
BREXIT Updated Impact Statement »
BREXIT Updated Impact Statement   It's less than a year until the UK leaves the EU. Every day passing leave...
18 April 2018   (0 Comments - view/add)
Latest EJPPS Journal Volume 23 Issue 1 available for download »
Latest Issue Volume 23 Issue 1 Contents Editorial: Managing the global suppliers Peer R...
26 March 2018
Annex 1 Consultation comments submitted »
PHSS have now formally submitted comments to the EMA as part of the Annex 1 consultation process. We would now like to sha...
20 December 2017   (0 Comments - view/add)
Annex 1 Consultation document issued »
Consultation on the revision of annex 1, on manufacturing of sterile medicinal products   Period of consul...
17 July 2017   (0 Comments - view/add)
PHSS PUPSIT Annex 1 Impact Statement 2017 »
Impact Statement - Annex 1 – (PUPSIT) (Pre-use & Post-use Sterilizing Filter Integrity Testing)  ...
05 April 2017   (0 Comments - view/add)
Latest Edition EJPPS Volume 22 Issue 1; Microbial contamination risks on surface ; Contact plates »
Latest Issue Volume 22 Issue 1   Contents Editorial:  Annex 1 and memory loss...
02 March 2017   (0 Comments - view/add)
Latest Edition EJPPS Volume 21 issue 4 »
Latest EJPPS Issue   Volume 21 Issue 4 EPUB Edition MOBI Edition PDF Version...
23 January 2017   (0 Comments - view/add)
PHSS Annex 1 Impact Statement 2017 »
Background   Assurance of sterility has always been a priority for regulators and industry / healthcare profe...
08 August 2016   (0 Comments - view/add)
“BREXIT” – Update on potential impacts on the pharmaceutical industry and its regulation »
Following the UK vote we have written an impact document to consider.   Background Prior to the UK’...
14 June 2016   (0 Comments - view/add)
The EU Referendum - Potential impacts on the Pharmaceutical industry and its regulation »
The EU Referendum - Potential impacts on the Pharmaceutical industry and its regulation. Background The PHS...
18 May 2016   (0 Comments - view/add)
Working document QAS/15.639/Rev.1: SUPPLEMENTARY GUIDELINES ON GMP FOR HVAC SYSTEMS FOR NON-STERILE »
World Health Organization : Working document QAS/15.639/Rev.1 May 2016  - Draft document for comment &...
20 January 2016   (0 Comments - view/add)
PHSS Announcement of George Sykes Memorial Award Winner 2015 »
Viability of microorganisms in novel chemical and biopharmaceutical anticancer drug solutions Iman Sarakbi, Matteo...
14 October 2015   (0 Comments - view/add)
New Annex 16 - deadline for coming in to operation 15th Apr 2016 »
  EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use  ...
30 July 2015   (0 Comments - view/add)
EMA - Submission comments on 'Concept paper on the revision of annex 1 of the guidelines on GMP' »
EMA  - Submission comments on 'Concept paper on the revision of annex 1 of the guidelines on GMP'   T...
20 July 2015   (0 Comments - view/add)
Impact Statement - Data Integrity »
Background -   The integrity of data has always been of importance in the pharma industry. It is one means of a...
06 May 2015   (0 Comments - view/add)
PHSS News! May 2015 »
Changing times and new challenges for the PHSS! We are making your life easier! The PHSS Management Committee (MC) hav...
05 May 2015   (0 Comments - view/add)
Impact statement Highly Potent Products – Dedicated Facilities »
Background EU GMP Ch 5 -Changes have been made to sections 17 to 21, including adding a new section, to improve the gui...

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