Lecture 6 Pharmaceutical inspection topic of interest Flashcards
on-site inspection
inspectors physically present at manu site to access company’s compliance with GMP or GXP standards and other regulatory requirements
remote inspection
- mimics on-site inspection, enabled by e-tech
- strives to mimic on-site inspection in terms of formate, time-frame and overall rigor
- offline, virtual
desktop inspection
form of remort inspection based on review of documentary evidence provided by the company
- largely ‘paper-based’
arrangements for remote inspections
- agree on virtual conference (inspection) platform
- assure strong internet/wifi connectivity and audio-visual resolution
- know the parties involved and their roles
- agree on inspection time and duration, and timezone for remote overseas inspections
- make arrangements relating to confidentiality, security and access to file-sharing platforms
- agree on safety arrangements such as use of handphones and video cameras: potential cross-contamination and explosion hazards
- deal with document system, comprising paper and electronic records: photocopiers, printer, tech staff on standby
challenges of remote inspection
- existing e-tech limitation due to unstable internet connectivity and poor AV resolution
- limited resources at manufacturing sites split teams)
- overal slower response time to complete remote inspection
- lack of body language (gesture, tone, smell) can distort discussion
- difficult to inspect utilities and Manu operations (eg. clean room, computerized system)
benefits of PIC/S membership
- reduced duplication of GMP inspections
2. increased opportunity for collaborations
spin off from SG PIC/S membership
- signing of SG-AUS MRA on GMP inspection 2001
- legal recognition of SG Pharma inspection system by AUS and vice-vera
- brought about ‘work-sharing’ program amongst TGA partners
TGA partners
- Swissmedic
- NZ Medsafe
- Health Canada
- Sg HSA
benefits of ASEAN MRA on GMP inspection
- avoids duplication of Pharma inspections within ASEAN
- saves time, resources and cost for Manu and regulators
- facilitates trade in medicinal product cross ASEAN
- quicker access of med products by ASEAN pt
- harmonises ASEAN inspection system too that of PIC/S
- increase attractiveness of ASEAN to regulators and investors from Asia and other parts of the world
objective ot ASEAN KSC
establish a register of ASEAN listed inspection services (LIS)
MRA
mutual recognition agreement
- take relatively long time to negotiate/conclude
- usually negotiated under larger platform of free trade agreement
- involves, regulators, lawyers, trade and industry representatives
frame work of PIC/S GMP inspection reliance includes
- having MRA on GMP inspection in place
- recognition of GMP compliance status of a facility located within territory of a PIC/S participating authority
- Recognition of inspection outcome by a hosting inspectorate which has been assessed under a robust framework (eg. PIC/S JAP or JRP
WHO good reliance practices
- covers reliance activity in regulation of med products
- spans entire product life cycle
- intended for all national regulatory authorities regardless of their maturity levels and resources
product life cycle includes
GMCPLL
- GMP inspection
- market authorization
- clinical trials oversight
- product quality surveillance and vigilance
- lab testing
- lot release (off vax)
what is reliance described by WHO good reliance practices
- an act whereby an NRA takes into account an assessment performed by another NRA in reaching its own decision
- relying NRA remains independent, responsive, and accountable for decision taken, even as it relies on assessment of another NRA
- not a less stringent form of regulation or an outsourcing of regulatory mandate
- hallmark of Morden and efficient regulatory authority and smart regulation
