Any company involved in the dietary supplement business has to establish and to follow GMPs to ensure that packaging and labeling is done as specified in the master manufacturing record and to ensure the quality of the product that reaches the market. The presentation provides an overview of these requirements.
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GMP Dietary Supplement Manufacturing
1. GMP Dietary Supplements
Manufacturing
A Presentation from
InstantGMP
InstantGMP: Electronic Batch Record System for GMP Manufacturing
2. Topics
Dietary Supplements
Dietary Ingredients
GMP Manufacturing of Dietary
Supplements
InstantGMP Manufacturing
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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3. What are Dietary
Supplements?
Orally ingested products that contain an
ingredient that is intended to supplement the
diet
Dietary supplements are under the "umbrella"
of foods at the FDA
Ingredients may be one or more of the
following:
an amino acid
a concentrate or extract of a plant material
an herb or other botanical
a mineral
a vitamin
InstantGMP: Electronic Batch Record System for GMP Manufacturing
4. FDA Review and Approval
Dietary supplements do not need approval
from FDA before they are marketed unless
they contain a new dietary ingredient
FDA must conduct a pre-market review for
safety data and other information on new
dietary ingredients before marketing
Manufacturers need to register themselves
pursuant to the Bioterrorism Act with FDA
before producing or selling supplements
InstantGMP: Electronic Batch Record System for GMP Manufacturing
5. How are Dietary Supplements
Supplied?
Available in many forms that can be
taken by mouth
Capsules
Softgel capsules
Gelcaps
Tablets
Liquids
Powders
InstantGMP: Electronic Batch Record System for GMP Manufacturing
6. Purpose of Dietary
Supplements
Ensure you have enough essential nutrients
May help reduce the risk of some diseases
Labeling may indicate health claims,
structure/function claims, and nutrient content
claims
Labeling may not indicate that a dietary
supplement is for treatment, prevention or cure
for a specific disease or condition
Only drugs can be used to "diagnose, treat,
cure or prevent a disease"
InstantGMP: Electronic Batch Record System for GMP Manufacturing
7. Who is Responsible?
Firms that manufactures or distributes dietary
supplements must:
make sure their products are safe
assure that any claims made about them have adequate
evidence to show that they are not false or misleading
register with the FDA before producing or selling
supplements according to the Bioterrorism Act
manufacture their products in accordance with GMPs
The FDA
does not approve dietary supplements on the market
before 1994
reviews and approves new dietary ingredients
restrict a product's use or remove it from the marketplace
if they show a dietary supplement is "unsafe"
InstantGMP: Electronic Batch Record System for GMP Manufacturing
8. What is the Cost of
Compliance?
The regulations for dietary supplement
GMP compliance estimated the cost of
compliance on small businesses
Dietary supplement business with less
than 20 employees will bear annual
costs of about $46,000
Business with up to 500 employees will
bear a cost of about $184,000 a year
InstantGMP: Electronic Batch Record System for GMP Manufacturing
9. Challenges of GMP Manufacturing
Good Manufacturing Practices are complex
Wide array of regulatory requirements
High time and cost to set up quality system
Long cycle times for QA review and corrections
Training and compliance to SOPs is lengthy
Documentation coordination and data tracking is
laborious
High cost of compliance
InstantGMP™ is the manufacturing system that has been built
from the ground up to meet these challenges
InstantGMP: Electronic Batch Record System for GMP Manufacturing
10. InstantGMP™ - A new approach to
pharmaceutical manufacturing.
Seamlessly incorporate everything necessary in
one place where it is visible all the time to
everyone via cloud-based application
Provides flexibility, speed, real-time access to
information
Uses proven quality procedures and efficient
data flow
Accelerates startup and rapidly reacts to
changes and delays without endangering
timelines
InstantGMP: Electronic Batch Record System for GMP Manufacturing
11. InstantGMP™ - The Manufacturing
Application
Founded on 21 CFR Part 11-compliant software
and an all-encompassing, paperless quality
system
Electronic Batch Record system with internet-
based infrastructure
Data is automatically visible to all decision-
makers at the same time
Eliminates delays created by traditional linear
processes
InstantGMP: Electronic Batch Record System for GMP Manufacturing
12. Advantages
InstantGMPTM enhances control, visibility,
efficiency and compliance of the regulated Life
Science manufacturing process
Manufacturing
Purchasing Project Team
QA
Sponsor Cloud
Server
InstantGMP: Electronic Batch Record System for GMP Manufacturing
13. Visibility
Available via the internet
Review and sign records from any location
Access controlled by firewall and security settings
Manages access for employees, partners or sponsors
ANYWHERE
ANY TIME
Remote Site Remote Site
Manufacturing
InstantGMP: Electronic Batch Record System for GMP Manufacturing
14. Efficiency
QC, QA, Warehouse, Purchasing, Inventory and
Manufacturing activities and records are linked
Some of the many features:
Standard specs, tests and vendors are reusable within the
system
Purchase Orders automatically created
Receiving materials and managing inventory is easy
Automated Master and Batch Production Record copies
make documentation creating and archival a snap
Inventory depletion as batch is being run creates less room
for error
Documents that are transmitted electronically and signed
electronically make it simple to speed up production
InstantGMP: Electronic Batch Record System for GMP Manufacturing
15. Efficiency
Vendors, Tests and Methods need to be added only once
InstantGMP: Electronic Batch Record System for GMP Manufacturing
16. ICH Q7A Good Manufacturing
Practice
International Conference on
Harmonization
ICH Member Countries –
European Union (EU) - 27 countries
Japan
United States
Australia
Canada
Norway
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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17. Basic of GMPs according to ICH
Instructions and procedures are clear and
unambiguous
Manufacturing processes are clearly defined and
controlled
Facilities designed to minimize cross-
contamination and mix-ups
Operators are trained
Records demonstrate that all required steps
were taken
Distribution minimizes any risk
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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18. Different approaches to GMPs
compliance depending on country
There is a global disequilibrium – quality and
compliance are different
A nation’s relative development dictates the level
of compliance they can afford
ICH signatories have the best quality
BRIC nations generally are struggling with the
cost of compliance, even while they recognize
the value for international commerce
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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19. InstantGMP starts with the Quality
System Structure
First step was design of
the quality system
structure
Next was design of
processes that link
material and process
controls together
Finally writing a
comprehensive
manufacturing solution
with compliance built-in
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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20. Automated Compliance
cGMP compliance controls are built into the system
Some of the many features:
Limited access based on user/role security settings
Purchasing restricted to approved materials and
vendors
Materials quarantine/restricted until QA approval
Specification version control
Master and Batch Record version control
Required signatures at specified batch record steps
Deviations must be approved before batch is
released
Complete automated audit trail
InstantGMP: Electronic Batch Record System for GMP Manufacturing
21. Manufacturing Facility Compliance is
Sponsor’s Responsibility
Facility and flow designed to minimize
potential contamination and mix-ups
Defined areas for:
Receipt
Quarantine
Storage
Production
Packaging
Washing
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22. Small Scale
CTM Manufacturing Facility Example
Material flow
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23. GMP Facility Inspection is Sponsor’s
Responsibility
FDA conducts facility inspections for
products to be sold in the US
Doesn’t include CTM facilities
Doesn’t include clinical stage products
UK and EU use UK’s “Orange Guide” to
check compliance
China, Japan, India et al rely on local
inspectors
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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24. Typical GMP Facilities in US and UK
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25. Materials
Only QA approved materials can be used
in CTM manufacturing
Excipients Containers/Closures
Components
Work in Process
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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26. Getting ready for manufacturing –
Control of Materials
API, excipients Assign Part #s,
and components tests, methods,
identified Specs
PM Initiates Vendors Specs
Yes Yes
Project Qualified? Approved?
Quality Quality
No Manager Manager
Project
Vendor Project
Manager Select Personnel
Qualification Definition
and Roles
Completed
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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27. Automatic Control
Automated rules and entries, that are based on the SOPs, are
integrated in the system.
Some of the many features:
System assigns lot numbers upon receipt
QA enters and controls raw material status based on QC
Lab input
System issues purchase requisitions
Production can only use approved raw materials
Drop downs for entries in batch records ensure accuracy
Electronic signatures allow remote, easy approvals
Security settings limit access to only authorized personnel
InstantGMP: Electronic Batch Record System for GMP Manufacturing
28. Vendors
QA shall qualify vendors for materials
used in CTM
Phase 1 CTM
Paper based quality survey
Phase 2 CTM
Either a paper based quality survey or an on-site audit
Phase 3 CTM
On-site audit
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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29. Rooms and Equipment
Room List – names of manufacturing rooms
Room Log – record of activities in rooms, e.g.
Cleaning
Maintenance
Batch use
Equipment List – names of production
equipment
Shows up in drop down lists in batch records
Equipment Log – similar to Room Log
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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32. Specifications
QA shall approve specifications of
materials and components
Test - A measurement of a quality attribute such as
potency or water content
Method - The procedure by which the quality
attribute is measured
Limit - The acceptable range for the attribute
Other Requirements
Sampling Instructions
Safety and Handling
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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33. Specifications
Specifications have
version control to
keep track of
changes
Most recent specs
apply, but old specs
must be kept
available for review
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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34. Specifications
Specifications can have Safety, Handling
and Sampling instructions
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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35. Specifications
Specifications include Test, Methods and
Limits that will go on Certificate of Analysis
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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36. Process Flow – Material Management
Receipt at Available for Bill
Warehouse Record into
Released Yes of Materials &
Inventory
Production
No
Quarantine, Quality
Facility Test & Manager
Manager Release
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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38. Inventory
Once materials are received, they automatically go into inventory with a
Quarantine status. Only QA can change the status.
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39. Automated Inventory Compliance
Materials need to be
In an approved status to
be used in batches
Materials need to have qualified
Vendors before being used in batches
Only a Quality Manager can update a material’s status
InstantGMP: Electronic Batch Record System for GMP Manufacturing
40. Quality Testing and Release is
Sponsor’s Responsibility
InstantGMP generates form that can be sent with sample to QC.
QA can update inventory status when material is released.
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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41. Process Flow - Production
Manufacturing
Instructions
Bill of Master Batch Approve
Materials Production Production Batch Record
In Process
Equipment
Tests
Quality Facility Sponsor
Manager Manager
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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43. Master Production Record
Bill of Materials
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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44. Master Production Record –
Manufacturing Instructions
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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45. Batch Production Record –
Manufacturing Instructions
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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46. Testing and Release of Final Product
is Sponsor’s Responsibility
Samples pulled from production batch
QC will test according to methods in
specifications
In US, QA will disposition batch after
final product in made in the US
in the UK and Europe, QP (Qualified
Person) is used for batch release
Finished products are entered into
inventory
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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47. Tracking of Inventory Distribution
InstantGMP: Electronic Batch Record System for GMP Manufacturing
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48. Security
Security Access assigned to:
• Each Person
• Each Role
• Each Screen
InstantGMP: Electronic Batch Record System for GMP Manufacturing
49. Quick Facts
Developed by the manufacturing and
quality experts at PharmaDirections
Integrated internet based application
developed through “Quality by Design”
approach
20 Core Standard Operating Procedures
built in
21 CFR Part 11 Compliant
System has been in use since 2004
InstantGMP: Electronic Batch Record System for GMP Manufacturing
50. InstantGMP™ Summary
Suite of virtual GMP manufacturing systems
Takes full advantage of cloud-based computing
21 CFR Part 11 compliant database with hard coded SOP
requirements
Streamlines entire process of producing GMP materials
Simplifies the documentation and approval procedures to
reduce production lead times
Ideally suited to making any GMP material including APIs,
drug products, OTCs, generics and dietary supplements
For more information, contact:
JPittman@InstantGMP.com
InstantGMP: Electronic Batch Record System for GMP Manufacturing