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
advantages of nanomeds
- effective in targeting difficult to reach (tumor) sites
- imported solubility, bioavailability and reduced side effects
- achievement of same therapeutic effect with smaller dose
- special properties de to its size, shape and surface chem
GMP and safety concerns of nanomeds
free nanoparticles released into the environment during Manu are potential health and cross contamination hazard
limitation of conventional product testing
- only test on a representative sample size
- can test onyx if you know the analyze and have a test method
- can test only if test method is specific, accurate and reliable
