The Pharmaceutical Quality Group is the longest established of the CQI’s special interest groups, which, since 1977, has met the needs of quality professionals within the pharmaceutical industry by :
- Providing a forum for support for the trainee and newly Qualified Person (QP) and on-going advice and support for all QPs.
- Arranging regular meetings on Quality Assurance, Good Manufacturing Practice and ‘hot-topics’.
- Developing monographs which provide guidance on a range of regulatory requirements.
- Developing GMP Application Standards and guidance for suppliers to the pharmaceutical industry.
- Managing a Certification Scheme for suppliers of materials to the pharmaceutical industry.
- Acting as the focus for regular liaison with representatives of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Organising co-operative ventures and meetings with several other groups e.g. IPEC, IPAC-RS, with which it shares a common interest.
- Maintaining a ‘Members only’ area on its website which provides much up to date information.
- Facilitating the opportunity to network with colleagues in the pharmaceutical industry enabling our members to improve their knowledge and skills to meet the ever changing requirements of our industry
Whilst our meetings are open to non-members, members pay a reduced rate with the discount being greater than the annual membership fee. In addition, the ‘Members only’ area on the website provides links to presentations and other information additional to that which is generally accessible.
- To promote the open exchange of information and experience concerning pharmaceutical quality matters.
- To promote the development of a consistent approach to pharmaceutical quality and good pharmaceutical practices.
- To promote the status of, and to represent, Qualified Persons and other pharmaceutical quality assurance professionals.
- To promote education and training in the achievement of pharmaceutical quality in line with current requirements for continuing professional development (CPD) and as a means of reducing risks to the quality of pharmaceuticals throughout the supply chain.
For further details see The constitution.
One of the main ways in which the objectives have been realised has been through various publications:
The PQG initiated a project in 1983 with the intention of writing a series of monographs, the prime objective of which was to augment the published, official Codes of Good Manufacturing Practice by providing practical, comprehensive and non-mandatory guidelines. The original series has been added to over the years and a number of titles have been revised to reflect the changing regulatory environment that we work in.
In addition to the monographs, PQG created a series of Supplier Codes of Practice in the early 1990s, which have been developed into the ‘PS Series’ Application Standards aligned with the ISO 9000 series and providing additional GMP guidance. The primary packaging component parts of PS 9000:2001 have subsequently led to the development of ISO 15378. The availability of relevant standards for the suppliers of packaging components led to the development of the PQG Certified Supplier scheme to which more than 120 suppliers have been certified.
In 2010, a Supply Chain Risk Management guide was produced.
PQG seeks to work with other organisations with similar aims and objectives. Monographs have been created in collaboration with The Packaging Society (Monograph 9: Pharmaceutical Packaging Validation), Pharmig (Monograph 12: Microbiological Control for non-sterile pharmaceuticals) and ECA (Monograph 4: Good Distribution Practice). GMP standards and PS publications have been produced in collaboration with IPEC and IPAC-RS. PQG is an observer member of Rx-360 and various members are involved in this organisation.