Formation and History of PQG

How did it all begin and where?

In October 1977 a few Quality Managers met up in a bar in Brussels before an EOQC (The European Organisation for quality Control) Pharmaceutical Sector Meeting at the suggestion of George Brady, Quality Director of Richardson Vicks.  The meeting was being held to assist in the preparation of ‘standardised’ European Questionnaires for Suppliers to the Pharmaceutical Industry with the aim of improving the quality of supplies to our industry.  This association of Quality Managers lead to the PQG being formed as a voluntary group that wanted to promote the open exchange of information and experience in pharmaceutical quality with Tony Harper as the first Chairman.

The first meeting in the UK was hosted by Tom Couling at Eli Lilly at Basingstoke and they followed at regular intervals thereafter at Member’s and other facilities.

The PQG Training course (1985-2005)

In 1984, The PQG identified that there were no training courses for the pharmaceutical industry in the “new” and growing subject of Pharmaceutical Quality Assurance.  Ivan Martin was instrumental in designing and delivering the course, in conjunction with Norman Randall, Barrie Clewes and Brian Meakin of the University of Bath.  The first Group Training Course, was run in 1985 at Bath entitled “The Fundamentals of Pharmaceutical Quality Assurance”.

The course was a great success, largely because the lecturers were PQG members, with considerable practical experience, which was passed on to the attendees.  After the second course was run at Bath University, it was moved to York 1989 and ran in conjuction with David Begg, who had just left the Medicines Inspectorate and formed a consultancy. Norman Randall and Keith Dobson acted as course supervisors for PQG until 2000 by which time there were several other competitor courses and it was becoming more difficult to get lecturers released by their employers to spend time at the course.  The last course ran in 2005.

The course, which is estimated to have trained close to 1000 attendees, developed the reputation of PQG for networking with experienced members of industry and with the Medicines Inspectorate.  It also made a profit for PQG every year which provided funds for the other activities of PQG.

Monographs

In 1986, some of the PQG Committee had lunch with Roger Baker, Head of the Medicines Inspectorate at that time.  He had been researching the literature on Pharmaceutical Quality Assurance.  His conclusion was that there was virtually none and he suggested that the PQG should write a textbook on Pharmaceutical Quality Assurance.

This lunchtime conversation led to the Monograph Project to which many of the Group members, past and present, have contributed. The project owes its initial success to Mike Bennoson for steering the project for several years leading to the publication of the first Monograph in 1987 and another 10 in subsequent years.  Barry Fisher, Paul Stockbridge and Dave Sanson followed as project leaders. 

PQG seeks to work with other organisations with similar aims and objectives and the last two Monographs have been created in collaboration with the Institute of Packaging (now the Packaging Society) and Pharmig, the pharmaceutical microbiology interest group.

Our sales have now exceeded 30,000 copies and these documents have been sold all over the world, and have been of great value to Members and others and are our best sellers.

Work on Standards

During the late 1980s, members of PQG had realised that there were no manufacturing standards specifically for the pharmaceutical industry and particularly for packaging components.  A series of Supplier Codes of Practice were further developed into the ‘PS Series’ Application Standards aligned with the ISO 9000 series and providing additional GMP guidance.

The standard provides additional GMP guidance to suppliers to the pharmaceutical industry and also allowed suppliers to become registered to the PQG Certified Supplier scheme.

Some of the content of PS 9000:2001 was used in the development of ISO 15378

In 2010, a Supply Chain Risk Management guide was produced.

In the period 2011-2013, PQG worked with IEC and other European professional groups to develop GMP standards and a Guide for excipents, which is now being used in many countries as a standard.  PQG was a major contributor in the development of the standard and methods of certification.

Management of PQG

PQG is managed by a committee of volunteers with a Chairman, Treasurer, Secretary as Officers and a number of other Committee Members governed by a Constitution.

Past & present Chairmen

  • Tony Harper
  • Mike Tait
  • Ian Richardson
  • Peter Gough
  • Norman Randall
  • David Mogg
  • Ashley McCraight
  • Phil Butson
  • Steve Moss
  • Neil Wayman (Current)

Past & present Secretaries

  • Tony Harper
  • Steve Pratt
  • Mike Tait
  • Ian Richardson
  • Chris Skiller
  • Debbie Berney
  • Caroline Fowler
  • Helen Chattaway
  • Sam Clack
  • Dave Waddington (Current)

 Past & present Treasurers

  • Tony Harper
  • Graham Davison
  • Phil Butson
  • Peter Cormack
  • Neil Wayman
  • Steve Moss(Current)