making gmp materials in a non-gmp space
TRANSCRIPT
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Achieving GMP in Non-GMP FacilitiesRequirements for Phase 1 Clinical
MaterialsRichard Soltero, Ph.D.
President
InstantGMP
InstantGMP: Electronic Manufacturing System for Small GMP Operations2
Typical GMP Facilities
InstantGMP: Electronic Manufacturing System for Small GMP Operations3
Typical Research Lab
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Benefits of Using non-GMP Lab
Phase 1 materials can be made in non-GMP facilities or in academic labs
Eliminating need to move from research lab to GMP facility saves time
Maintaining a Non-GMP facility is less costly
Single GMP batch used for tox and clinical saves analytical costs
InstantGMP: Electronic Manufacturing System for Small GMP Operations
FDA Guidance for Phase 1 GMP
Guidance for IndustryINDs — Approaches to Complying with CGMP
During Phase 1 Defines rules for applying quality control
principles Facilitates Phase 1 trials while protecting
study subjects Covers small or lab scale production
InstantGMP: Electronic Manufacturing System for Small GMP Operations
QC Procedures Requirements Written procedures that are well defined Equipment that is adequately controlled Data from production that is accurately
and consistently recorded
InstantGMP: Electronic Manufacturing System for Small GMP Operations
GMP Documentation Required1. Personnel and training
2. QC plan
3. Facility and Equipment procedures
4. Control of Components
5. Written Procedures for Production
6. Change Control
7. Laboratory Controls
8. Container Closure and Labeling Controls
9. Distribution Documentation
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Record Keeping Requirements Equipment maintenance and calibration Production records and related
analytical test records Distribution records All quality control functions Component records Maintain records for 2 years after trial
completed
InstantGMP: Electronic Manufacturing System for Small GMP Operations
InstantGMP™ Makes Meeting Requirements Easy InstantGMP™ provides compliance with
FDA guidance for Phase 1 supplies. Permits GMP work in same
equipment/lab as research work Lets academic labs produce GMP
materials Allows Non-GMP facilities to be used for
making Phase 1 trial materials
InstantGMP: Electronic Manufacturing System for Small GMP Operations
InstantGMP™ - The Manufacturing Application
All-encompassing electronic batch record system that streamlines entire end-to-end production of GMP materials
CFR 21 Part 11-compliant software using an Internet-based infrastructure
Data is automatically visible to everyone at the same time
Maintains quality compliance automatically
Makes any facility GMP compliant
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Comprehensive Solution to GMP Production
Electronic Batch Record System
Streamlines end-to-end production process
Information accessed and work is done from any internet connection
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Documentation more Efficient
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Quality Checks Built In
Materials need to beIn an approved status to be used in batches
Materials have to come from qualified Vendors before being used in batches
Only a Quality Manager can update a material’s status
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Review all areas of batch record via tabs:
Review and update manufacturingsteps online
Master and Production Batch Records are Easy to Use
InstantGMP: Electronic Manufacturing System for Small GMP Operations
Quick Facts
Developed by the manufacturing and quality experts at PharmaDirections
Integrated application developed using “Quality by Design” approach.
Manufacturing Standard Operating Procedures included with application
21 CFR Part 11 Compliant Software has been in use since 2004
InstantGMP: Electronic Manufacturing System for Small GMP Operations
InstantGMP™ Electronic Batch Record system Streamlines entire process of
producing GMP materials Simplifies production and
documentation procedures Ideally suited for making Phase 1
clinical materials in a non-GMP facility For more information, contact: