New product introduction Flashcards
Tell me how you would launch a new product and submit a MAA?
Raise a CHANGE CONTROL
Annex 16, 2001/83/EC, SI 2012 /1916,
Involve a multidisciplinary team
Perform a Quality Risk Assessment – Check MIA ( Any other licences eg Controlled Substance)
QP Knowledge – specials, steriles, Biologics ATMP’s, IMP’s etc
Review documentation – Audits, Supplier Management, Batch documents, Validation
Equipment – Sourcing / Validation
Raw Material / Finished Product Specifications -Analytical Method Transfer – ICH Q2
Technical Agreements
SAP Codes
Nitrosamine Risk Assessments / Elemental Impurities Risk Assessments / Residual Sovents ICH Q3, ICH M7
Artwork Approval / Printed Packaging
Your company is taking a new product IMP – what considerations are you going to make before and then during GMP manufacture?
What is the product ? What is it used to treat? What is the proposed Study / Trial?
Check for MIA (IMP)
SI 2004/1031, 536 / 2014, 2017/1569, API – 2011/83/EC, 1252/2014, 2015/C95/01
Change Control
Multidisciplinary Team
CTA submitted, PSF ?
Risk Assessment as part of Change
Technical Agreements
Audits
Sponsor
Sourcing / Specs of starting Materials
Tech Transfer – Methods
You talked about a risk assessment for potency – why is that important?
Feeds in to contamination control strategy, If this is a multi-product facility
Why is product type important?
Allergens, High Potency Products – potentially require dedicated facilities, cleaning validation etc
Why would you not accept a celphasporin or b-lactam?
These are both highly allergenic, require very specific contamination control strategies – dedicated facilities and equipment.
You mentioned TSE for raw materials – what is it certifying on the certificate and what materials would you need it for?
Needed for all excipients and API, declaration of absence of TSE / BSE – material is not sourced from animal origin in order to comply with the requirements of your MA.
