Planning

Contractor for quality assurance for PETIC department

CARDIFF UNIVERSITY

This public procurement record has 1 release in its history.

Planning

19 Feb 2025 at 00:00

Summary of the contracting process

Cardiff University is in the planning stage of a public procurement process to source a contractor for quality assurance for the PETIC department, following a regulatory inspection in November. The university, classified under the education sector (COFOG category 09), is located at Procurement Services, The Spark Building, 3rd Floor, Maindy Road, Cardiff. The procurement process is expected to transition to the tender stage with a notice scheduled for release on 14th March 2025. The contractor will support quality assurance processes within the PETIC department over an initial period of six months. The procurement is categorized under services with a CPV classification of 72225000, and it is covered by the GPA and based on the CELEX legal framework.

This tender presents an excellent opportunity for businesses experienced in quality assurance within a GMP manufacturing environment, particularly those familiar with aseptic/sterile manufacture and radiopharmaceuticals. Cardiff University's requirement for a contractor capable of overseeing workflow management, documentation, quality assessments, and supplier management tasks means companies with a proven track record in these areas can gain significant exposure and credibility. Additionally, businesses that specialise in remediation activities and have an appreciation for regulatory compliance in niche pharmaceutical manufacturing would be well-suited to compete in this tender.

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Notice Title

Contractor for quality assurance for PETIC department

Notice Description

Following a regulatory inspection in November, PETIC is looking to source a temporary contractor to support quality assurance processes in PETIC for a period of 6 months in the first instance.

Lot Information

Lot 1

PETIC requires QA support for managing workflows Documentation, quality trackers, Q-Pulse, completion and closure of paper and electronic records, as well as support for Supplier Management and executing self-inspections. In addition to these routine tasks, the contractor would need to assist with Quality Assessment of Deviations and Quality Events, assessment and approval of CAPA. Potential contractors need to have experience of QA activities within a GMP Manufacturing environment, given PETIC's very specific and niche product portfolio, we require someone with an understanding of aseptic/sterile manufacture, and it would be desirable for them to have experience of radiopharmaceuticals, and an appreciation of remediation activities.

Publication & Lifecycle

Open Contracting ID
ocds-kuma6s-148257
Publication Source
Sell2Wales
Latest Notice
https://www.sell2wales.gov.wales/search/search_switch.aspx?ID=148257
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
OJEU - F1 - Prior Information Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
Not specified
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

72 - IT services: consulting, software development, Internet and support


CPV Codes

72225000 - System quality assurance assessment and review services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
19 Feb 20251 years ago
Submission Deadline
Not specified
Future Notice Date
14 Mar 2025Expired
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Planned
Lots Status
Planned
Awards Status
Not Specified
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
CARDIFF UNIVERSITY
Contact Name
Not specified
Contact Email
rogalaa@cardiff.ac.uk
Contact Phone
+44 2920879648

Buyer Location

Locality
CARDIFF
Postcode
CF24 4HQ
Post Town
Cardiff
Country
Wales

Major Region (ITL 1)
TLL Wales
Basic Region (ITL 2)
TLL5 South East Wales
Small Region (ITL 3)
TLL52 Cardiff and Vale of Glamorgan
Delivery Location
TLL22 Cardiff and Vale of Glamorgan

Local Authority
Cardiff
Electoral Ward
Cathays
Westminster Constituency
Cardiff South and Penarth

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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