1. Achieving GMP in Non-GMP Facilities
Requirements for Phase 1 Clinical
Materials
Richard Soltero, Ph.D.
President
InstantGMP
InstantGMP: Electronic Manufacturing System for Small GMP Operations

2. Typical GMP Facilities
InstantGMP: Electronic Manufacturing System for Small GMP Operations
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3. Typical Research Lab
InstantGMP: Electronic Manufacturing System for Small GMP Operations
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4. 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

5. FDA Guidance for Phase 1
GMP
 Guidance for Industry
 INDs — 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

6. 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

7. GMP Documentation Required
1. 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

8. 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

9. 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

10. 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

11. 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

12. Documentation more
Efficient
InstantGMP: Electronic Manufacturing System for Small GMP Operations

13. Quality Checks Built In
Materials need to be
In 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

14. Master and Production Batch
Records are Easy to Use
Review all areas of batch record via tabs:
Review and update manufacturing
steps online
InstantGMP: Electronic Manufacturing System for Small GMP Operations

15. 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

16. 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:
JPittman@InstantGMP.com
InstantGMP: Electronic Manufacturing System for Small GMP Operations