Formal notification of outcome of validation
The Department of Academic Quality (DAQ) will circulate
formal notification of the validation outcomes within five
days of the validation event. If DAQ is not represented on a
devolved validation panel, it is the responsibility of the
validation servicing officer to provide the Curriculum
Planning Office in DAQ with the relevant information.
Preparation of report and validation
follow-up
The outcome of the validation will be fully documented in a
report, written by the validation servicing officer, which
should be finalised and circulated within five weeks of the
validation event. Details of the validation outcome and any
associated conditions and recommendations should be
circulated to the programme team in draft format within 48
working hours of the validation event, so that work can
commence in response to the issues raised. The initial draft
of the full report should be sent to the panel chair no later
than a week after the event, with a week to submit any
comments and/or amendments. The draft should then be
revised, as required, and circulated promptly to the
remaining panel members for comment/amendment, also
giving them a week to respond. Once approved by the
panel, the draft report should then be circulated to the
programme leader, for comment in terms of factual
accuracy, again giving a week to consider and submit
comments.
Validation servicing officers should identify cut off
dates for panel members to submit comments on the
draft report. If you haven’t heard from them by the
date identified, you should assume they are happy
with the report as it stands.
A template for the validation report can be found on the
DAQ intranet site: intranet.dmu.ac.uk/qa/.
Circulation of final report
The final, approved report should be circulated to a number
of key individuals, as detailed on the validation report
template. These include the programme team, the relevant
programme management board, the faculty Head of Quality,
the Dean and the Faculty Academic Committee (FAC). The
programme management board receives the report for
formal consideration, and the Dean and the FAC, for formal
endorsement.
A copy of the report must also be sent to the University’s
Quality Assurance Manager, for presentation to the
Academic Quality and Standards Committee (AQSC) and
for audit and monitoring purposes, and to the Curriculum
Planning Office, along with the signed approval form, for
actioning within the University’s systems and modular
scheme. On receipt of the validation report and the
approval form the Curriculum Planning Office will allocate a
programme code to the new provision to allow its input
onto QLS and will inform the relevant central departments
of the validation outcome.
Responding to conditions
It is the responsibility of the faculty Head of Quality to
oversee the process of meeting conditions of approval. The
faculty Head of Quality should ensure that:
• The documentation submitted in response to conditions
is received by the date specified in the validation report
• A copy of the response to conditions is forwarded by the
validation servicing officer to the external advisor(s) for
approval, as appropriate
• The chair of the validation panel formally and in writing
approves the responses to conditions, if appropriate,
submitting this to the validation servicing officer
• If the conditions of approval are deemed not to have been
fully met, a further response is requested from the
programme team, again to be endorsed by the relevant
panel member(s).
The programme leader is responsible for co-ordinating the
follow-up activity. This will include the provision of evidence
to the panel that changes have been made and action taken
in response to the conditions set, as well as the preparation
of a formal response to any recommendations. The
documentation produced must be sent to the validation
servicing officer for onward transmission to the panel.
Where they have received responses, panel members must
confirm to the validation servicing officer that they are
satisfied with the action taken in response to the conditions
and recommendations set.
The relevant programme management board will monitor
progress and seek reports of action taken to address the
issues therein, in line with the deadlines set by the
validation panel. The validation servicing officer will be the
conduit for the follow-up action and should provide
notification/updates on responses to conditions as
appropriate. To facilitate this responsibility, the validation
Section 5: After the validationservicing officer is encouraged to use a simple Excel
spreadsheet, which will allow for the tracking of progress
and the identification of any overdue actions which need to
be chased.
For devolved validations, it is the responsibility of the panel
chair to write to the Dean of the relevant faculty to confirm
progress in meeting conditions, including final confirmation
that all conditions have been met. For non-devolved
validations, responsibility for this rests with DAQ.
Maintaining records
For devolved validations, a validation file should be
maintained within the faculty and should contain the
following:
• Completed and signed New Programme Planning and
Approval Form
• The minutes of all relevant programme management
board/Faculty Academic Planning Committee
(FAPC)/FAC meetings at which the development was
discussed
• The minutes and notes of all programme team/project
team meetings at which the development was discussed
• Complete set of validation documentation, including panel
membership, appendices etc
• Completed nomination form for external panel member,
signed off by Dean and Head of Department of Academic
Quality
• Validation report and evidence of approval by panel
• Correspondence showing circulation of report to all
relevant personnel
• All responses to conditions and recommendations, as
appropriate
• The minutes of all relevant programme management
board and FAC meetings at which the validation report
and the programme team’s responses to it have been
considered and endorsed
• All correspondence with the panel chair and other panel
members showing consideration, and ultimately, approval
of the responses. In particular, correspondence from the
panel chair indicating that all conditions have been met to
the satisfaction of the panel, thus indicating full approval
for the programme to commence.
DAQ will maintain the records for all non-devolved
validations.
Validation checklists for validation servicing officers and
programme leaders can be found on the DAQ intranet site
(intranet.dmu.ac.uk/qa/).
validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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