• Like
  • Save

GMP Dietary Supplement Manufacturing

  • 1,710 views
Uploaded on

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 …

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.

  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
No Downloads

Views

Total Views
1,710
On Slideshare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
0
Comments
0
Likes
1

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1. GMP Dietary Supplements Manufacturing A Presentation from InstantGMPInstantGMP: Electronic Batch Record System for GMP Manufacturing
  • 2. Topics  Dietary Supplements  Dietary Ingredients  GMP Manufacturing of Dietary Supplements  InstantGMP ManufacturingInstantGMP: Electronic Batch Record System for GMP Manufacturing 2
  • 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 vitaminInstantGMP: 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 supplementsInstantGMP: 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  PowdersInstantGMP: 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 products 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 yearInstantGMP: 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 challengesInstantGMP: 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 timelinesInstantGMP: 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 processesInstantGMP: 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 ServerInstantGMP: 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 ManufacturingInstantGMP: 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 productionInstantGMP: Electronic Batch Record System for GMP Manufacturing
  • 15. Efficiency Vendors, Tests and Methods need to be added only onceInstantGMP: 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  NorwayInstantGMP: Electronic Batch Record System for GMP Manufacturing 16
  • 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 riskInstantGMP: Electronic Batch Record System for GMP Manufacturing 17
  • 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 commerceInstantGMP: Electronic Batch Record System for GMP Manufacturing 18
  • 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-inInstantGMP: Electronic Batch Record System for GMP Manufacturing 19
  • 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 trailInstantGMP: 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  WashingInstantGMP: Electronic Batch Record System for GMP Manufacturing 21
  • 22. Small Scale CTM Manufacturing Facility Example Material flowInstantGMP: Electronic Batch Record System for GMP Manufacturing 22
  • 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 inspectorsInstantGMP: Electronic Batch Record System for GMP Manufacturing 23
  • 24. Typical GMP Facilities in US and UKInstantGMP: Electronic Batch Record System for GMP Manufacturing 24
  • 25. Materials Only QA approved materials can be used in CTM manufacturing Excipients Containers/Closures Components Work in ProcessInstantGMP: Electronic Batch Record System for GMP Manufacturing 25
  • 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 CompletedInstantGMP: Electronic Batch Record System for GMP Manufacturing 26
  • 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 personnelInstantGMP: 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 auditInstantGMP: Electronic Batch Record System for GMP Manufacturing 28
  • 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 LogInstantGMP: Electronic Batch Record System for GMP Manufacturing 29
  • 30. Room LogInstantGMP: Electronic Batch Record System for GMP Manufacturing 30
  • 31. Equipment LogInstantGMP: Electronic Batch Record System for GMP Manufacturing 31
  • 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 HandlingInstantGMP: Electronic Batch Record System for GMP Manufacturing 32
  • 33. Specifications Specifications have version control to keep track of changes Most recent specs apply, but old specs must be kept available for reviewInstantGMP: Electronic Batch Record System for GMP Manufacturing 33
  • 34. Specifications Specifications can have Safety, Handling and Sampling instructionsInstantGMP: Electronic Batch Record System for GMP Manufacturing 34
  • 35. Specifications Specifications include Test, Methods and Limits that will go on Certificate of AnalysisInstantGMP: Electronic Batch Record System for GMP Manufacturing 35
  • 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 ReleaseInstantGMP: Electronic Batch Record System for GMP Manufacturing 36
  • 37. ReceivingInstantGMP: Electronic Batch Record System for GMP Manufacturing 37
  • 38. Inventory Once materials are received, they automatically go into inventory with a Quarantine status. Only QA can change the status.InstantGMP: Electronic Batch Record System for GMP Manufacturing 38
  • 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 statusInstantGMP: 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 40
  • 41. Process Flow - Production Manufacturing Instructions Bill of Master Batch Approve Materials Production Production Batch Record In Process Equipment Tests Quality Facility Sponsor Manager ManagerInstantGMP: Electronic Batch Record System for GMP Manufacturing 41
  • 42. Master Production RecordInstantGMP: Electronic Batch Record System for GMP Manufacturing 42
  • 43. Master Production Record Bill of MaterialsInstantGMP: Electronic Batch Record System for GMP Manufacturing 43
  • 44. Master Production Record – Manufacturing InstructionsInstantGMP: Electronic Batch Record System for GMP Manufacturing 44
  • 45. Batch Production Record – Manufacturing InstructionsInstantGMP: Electronic Batch Record System for GMP Manufacturing 45
  • 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 inventoryInstantGMP: Electronic Batch Record System for GMP Manufacturing 46
  • 47. Tracking of Inventory DistributionInstantGMP: Electronic Batch Record System for GMP Manufacturing 47
  • 48. Security Security Access assigned to: • Each Person • Each Role • Each ScreenInstantGMP: 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 2004InstantGMP: 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.comInstantGMP: Electronic Batch Record System for GMP Manufacturing