Study Set Content:
M9
BIOPHARMACEUTICS CLASSIFICATIONS SYSTEM (BCS)-BASED BIOWAIVERS
M10
BIOANALYTICAL METHOD VALIDATION
M11
CLINICAL ELECTRONIC STUCTURED HARMONISED PROTOCOL(CESHARP)
M12
DRUG INTERACTION STUDIES
M13
BIOEQUIVALENCE FOR IMMEDIATE-RELEASE SOLID DOSAGE FORM
PIC/S
Pharmaceutical Inspection Cooperation Scheme
To lead the international development,
implementation and maintenance of harmonized
GMP standards and quality systems of
inspectorates in the field of medicinal products
PICS GOAL
Main features of PIC/S
● Commenced operation on
Nov. 2, 1995
A (blank) between GMP
regulatory authorities.
“cooperative arrangement”
A forum for:
▸Networking and confidence building
▸Exchange of information and experience on GMP
▸Focus on Quality Systems for Inspectorates
▸Focus on training of inspectors
▸International harmonization of GMP
No obligation for member authorities to accept
inspection reports of other members
PIC/S Members
● Australia
● Belgium
● Canada
● Chinese Taipei
● Croatia
● Cyprus
● Czech Republic
● Denmark
● Estoria
● Finland
● France
● Germany
● Greece
● HongKong SAR, China
● Hungary
● Iceland
● Indonesia
● Iran
● Ireland
● Israel
● Italy
● Japan
● Korea
● Latvia
● Liechtenstein
● Lithuania
● Malaysia
● Malta
● Mexico
● Netherlands
● New Zealand
● Norway
● Poland
● Portugal
● Romania
● Singapore
● Slovak Republic
● Slovenia
● South Africa
● Spain
● Sweden
● Switzerland
● Thailand
● Turkey
● Ukraine
● United Kingdom
● USA
Main Benefits For Members
● Training opportunities
● International GMP harmonization
● Networking
● High standards
● Sharing of information
● Rapid Alert System
● Facilitation the conclusion of other agreements
Indirect Benefits for Industry
● Reduced duplication of inspections
● Cost savings
● Export facilitation
● Enhanced market access
organizational structure
Some PIC/S Recommendation & Guidance
Documents
● Validation (master plan, process, cleaning)
● Validation of Aseptic Processes
● Inspection of Isolator Technology
● Sterility Testing
● Parametric release
● Guidance on Good Practices for Computerized Systems in Regulating GXP Environments
● Inspection of Utilities
● SOP on PIC/S inspection report format
● SOP on Rapid Alerts
▸The need for inspection determined from
computerized schedule.
Before the inspection:
▸Lead inspector assigned.
Before the inspection:
▸Assembly of inspection team (on site).
After the inspection:
▸Deficiency report prepared on site (some PIC/S
members only).
After the inspection:
