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PIPA PSMF Guidance Document Questionnaire Responses
Question 1
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Are you involved in development and / or maintenance of your
company's PSMF? Answered: 50 • Skipped: 0
YES NO
94% 6%
Total Answers
50
Question 2
What would you like to see in a PIPA PSMF guidance document?
Answered: 49 • Skipped: 1
Post Brexit Challenges
17 Answers were relevant to post-Brexit PSMF related aspects (e.g, how to manage a PSMF to fulfill UK and NI specific legal requirements; UK specific guidance; how to link UK and EU PSMF; guidance on overlaps and differences). Detailed answers as follows:
• How to produce a UK PSMF and How to link UK and EU PSMFs • How different types of MA appear in EU or UK PSMF • How to manage a core PSMF to fulfill UK and NI specific requirements and legal requirements in different regions • How to represent the required information and what each section should contain to fulfill UK and NI specific requirements and legal requirements in different regions • How to create UK specific annexes • Template of a typical PSMF and all of the annexes • Guidance for NI Protocol
Local vs Global
9 answers were relevant to the management of core PSMF vs different local requirements (Global vs Local). For example: How to write a Corporate PSMF that could align with the local regulatory requirements; a summary of differences in requirements for the different regions; summary of relevant legislation/guidance documents; how to manage Annexes; list of all applicable requirements
PSMF Management General Aspects
PSMF General Aspects Management
Global vs Local
23 answers were relevant to general PSMF management aspects (what is the appropriate level of detail?; how often to should the PSMF be updated?; what is the content of the body vs annex, example templates and tips).
In addition, the following answers were received: • What should be included in the logbook? • Which deviations/CAPAs to include (all that are relevant to PV or just the critical ones) • Which non-PV SOPs to include • How to manage KPIs • Should you record DSUR submission metrics in KPI Annex? • Should you include processes relating to DSUR as outputs may affect risk management? • Information on how to list different medicinal products with the same active ingredient • How to ensure content, particularly of annexes, remains accurate and up to date • How to manage multiple versions • Practical tips and advice on PSMF creation and maintenance
Question 3
What do you consider to be the 'great unanswered questions' about
the PSMF? Answered: 44 • Skipped: 6
• 6 answers were relevant to the appropriate level of detail to be provided in PSMF • 2 answers were relevant to what goes in annexes versus what goes in the body • 5 answers were relevant to the update frequency • 2 answer were relevant to the need to sign and who should sign it • 3 were relevant to the need of a template • 2 were relevant to possible use of technology • 2 were relevant to management of cover page • 3 on how to decide if one PSMF is enough and how to make it acceptable for all the Agencies • 2 on thresholds to include contractual agreements • 2 on which vendor to be included • 2 were relevant to inspection findings
• 11 were relevant to management UK specificities (e.g. which content to include in UK PSMF vs EU PSMF), how to streamline processes and how to avoid duplication of effort • 9 were relevant to management of multiple local versions (e.g.Saudi) and how to streamline processes
Details of above mentioned answers: • How to adapt processes for EU PSMF versus UK PSMF to streamline process and reduce duplicate work • Managing multiple versions e.g. UK, EU Saudi etc • Global PSMF covering all countries who are affiliates, how do you go about creating a local PSMF without risking duplication
Question 4
What do you consider to be the greatest challenges developing a PSMF?
Answered: 46 • Skipped: 4
15 Answers were relevant to the difficulty to collaborate with different functions or with global functions and difficulties in collecting data from multiple stakeholders (other functions or from global PV)
Some details of answers: • Accommodating multiple country requirements • Vendor listings (clear guidance on which kind of vendors the PSMF should list) • Collecting information from multiple stakeholders (multiple departments, partner organisations and vendors as well as non-GxP departments) • Mainteinance of annexes • Identifying what needs to be included and how much detail • Maintenance of both an EU and a UK PSMF • Increasing awareness of the importance of the PSMF • Lack of templates • Understanding the scope of the MAH's PV system • How to decide the "cut off point" between finalising different versions of the PSMF • The time taken to prepare the PSMF when PV resource is limited and other routine activities are completed as well • Ensuring that it contains accurate and all required information • Interpreting the regulations. Some parts are vague and our interpretation can be different from an inspectors • How to present your data so it is easy to follow the flow of information throughout the document • Setting up and maintaining KPIs for Global scope
Question 5
How many different PSMFs does your company have?
Answered: 47 • Skipped: 3
• 10 responders answered “1” • 16 responders answered “2” (1 added “(EU and UK) and 1 local (France)” and another one added “EU and UK”) • 4 responders answered “3” • 5 responders answered “4” • 1 responders answered “5” • 1 responder answered “6” • 1 responder answered 10+
Question 6
Which countries / regions do your company's PSMFs cover?
Answered: 48 • Skipped: 2
• 17 responders answered “EU and UK” • 4 responders answered “UK only” • 2 responders answered “EU” Countries covered included: EU, UK, India, Middle East regions, Brazil, Switzerland, Eurasian region, Arab region
Question 7
Does your company have a PSMF that covers UK products?
Answered: 50 • Skipped: 0
Yes 9 (18%)
No
If yes, is it separate from your company's EU PSMF? 3 (6%)
• 18 responders answered “yes” • 11 responders answered “no” • 9 had hybrid models with the same
PSMF body and EU and UK specific cover letters and/ annexes
