Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™ Soft Softwar are Orie ientation ion Slid Slides
Topics To Master Production Overview Batch Production Record Workflow Record Workflow • Purpose of GMPs • Materials • Purchasing • Quality Systems • Products to be • Material Receipt • GMP Process Flow manufactured • Batch Production • Specifications Training Overview • Inventory • Master Production • Summary • Training Preparation Records • Scheduling Appointments
Ins Instan antG tGMP P Quic uick Fac acts ts • Cloud-based • Team of GMP manufacturing and quality experts used to guide software development • 21 CFR Part 11, GAMP 5 and FDA validation requirements met • Software has been in use since 2004
FD FDA Requir equires es SOPs for GMP P Complianc pliance
Ins Instan antG tGMP P Cons nsulting ulting • Process Consulting • Help in making the transition from manual systems to electronic batch records • Create company specific Master Production Records (MPR) • Map company specific process flows • GMP Consulting • Assist in understanding GMP requirements • Help in developing a quality system for a manufacturing site • Advise on setting specifications and choosing tests and methods for raw materials and finished products • Teach GMP 101 course or annual GMP training
Who Who Mus ust Follow w cGMPs? s?
Ba Basic Tenants of of GM GMPs FDA Mantra: “ If it wasn’t documented, it wasn’t done!” • Instructions and procedures are clear and unambiguous • Manufacturing processes are clearly defined and controlled • Facilities are designed to minimize cross-contamination and mix- ups • Operators are trained • Records demonstrate that all required steps were taken • Distribution minimizes any risk • Manufacturing is governed by a Quality System consisting of Policies and SOPs 7
Pu Purpose of Good Manufacturing Pr Practices Fo Following FDA Gi Gives s you re require rements for Good co consistent nt, high Ma Manufacturi ring qua quality pr product ducts Practices Pr
Qu Quality S System • Quality = meeting specifications • Quality Control = testing to ensure specifications are met • Quality Assurance = review of testing results and promotion of practices intended to ensure quality • Quality System – policies, standard operating procedures and other documentation that define the practices needed to ensure quality • Good Manufacturing Practices lay the foundation for a quality system
Good Manufacturing Practices Work Flows Reinforced in InstantGMP Master Production Record Batch Production Record Work Flow Work Flow Enter materials needed for manufacturing Requisition materials and components Receive materials into inventory Enter products to be manufactured and approve for use Establish material and product specifications Generate Batch Production Record Organize Products into Projects Capture production data Prepare Master Production Record Add batch to inventory
Master Production Record Work Flow Enter materials needed for manufacturing Enter products to be manufactured Establish material and product specifications Organize Products into Projects Prepare Master Production Record
Sy System Generated Numbers Part # Material Specification w/Version # Specifications Requisition # Purchase Order Receipt # Warehouse Receiving Master Record w/Version # Master Record Batch # Production
Ma Materi rials • Two classifications of materials: • Materials used in manufacturing • Raw Material • Incoming WIP • Other • Materials that are manufactured • Outgoing WIP • Finished Goods • Each Classification has a different input screen
Ma Materi rials u used i in ma manufacturi ring • Default types provided in InstantGMP • Part # automatically assigned • Material ID captures legacy numbering system
Ma Materi rials t that a are ma manufactured Products used in creating • an MPR - Outgoing WIP - Finished Goods
Sp Speci cification ons • Make sure you are getting the right materials from your vendors • Allow you to verify identity, purity, strength and composition • Ensure you have the right ingredients in the product • Keep contaminants from adulterating a batch • Establish the basis of quality for your final product
Sp Speci cification ons Ne Needed F For: or: • Components • In-process production • Labels and packaging • Finished batch of product • Packaging and labels • Received products
Ins Instan antG tGMP P Spec pecif ific icatio tion n Entr try Screen een Example: Specifications have to be approved before material can be ordered or used in a batch
Ins Instan antG tGMP P Spec pecif ific icatio tion n Entr try Screen een Example: Each specification must have tests, methods and acceptance limits
Pr Projects
Ad Add a WIP/FG to a Project 2. Select a Material Name 1. Click Add WIP/FG Part # Only FG and oWIP (outgoing WIP) show in the list
Ad Add a WIP/FG to a Project 3. Create a Product Name • Material Name + Strength + Container + Suffix must be a unique combination for each Product Name • Strength, Container and Suffix are optional
Ad Add / D / Delete a a WI WIP/FG in in a a Projec ect • Multiple products can be added to any project • Product can be modified or deleted up until the product is used in an approved MPR
Cr Creating a new MP MPR • Project/Product/Client combination creates flexibility • Strength is inherited from Product Name • Batch Unit is inherited from Tmaterial • Unique for each MPR lineage of versions • Product Name/Strength • Client • Formulation ID • Theoretical Batch Yield • Batch Unit Definitions of “Theoretical Batch Yield” and “Batch Size” added
MP MPR V Version oning • Each new MPR version will be a copy that can be edited except for the following that will be kept constant: • Product Name/Strength • Client • Formulation ID • Theoretical Batch Yield • Batch Unit
MP MPR St Status D Definition ons • Approved • All approvers signed • BRP can be made from MPR • In-Process • No approvers signed • MPR can still be edited • Locked • At least one approver, but not all signed • Rejected • One approver rejected MPR
MP MPR Cop Copy • Only Approved or Rejected MPRs can be copied • All information is copied and is editable • At least one of the following must change (to qualify as a copy not a version up): • Product Name • Strength • Formulation ID • Theoretical Batch Yield • Batch Unit
MP MPR V Version on U Up • Only Approved or Rejected MPRs can be “Versioned Up” • All information is copied and is editable except the following: • Product Name • Strength • Formulation ID • Theoretical Batch Yield & Unit • Materials • “Reason for Change” is required field on MPR Cover page
MP MPR Sc Scale U Up/D /Down • Only Approved or Rejected MPRs where the BOM QTY is checked can be scaled • All information is copied and is editable except the following: • Product Name • Strength • Formulation ID • Batch Unit • Materials • Quantities in BOM and mfg instructions will be calculated based on new Theoretical Batch Yields • Version will be 1 and MPR will be unique
MP MPR Su Summa mmary Sc Screen • Summary includes: • Cover page • Materials to be used • Equipment • In-process tests • Manufacturing instructions • MPR approvals
Batch Production Record Work Flow Requisition materials and components Receive materials into inventory and approve for use Generate Batch Production Record Capture production data Add batch to inventory
Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™ Orientation Part Three: : Batch Pr Production Record
Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™ Orientation Part Three: : Batch Pr Production Record
Wh Why y Batch h Records ds are Impo portant • Shows when product was produced • Documents actual times of procedures and amounts of materials used; etc. • Assures consistency in how processes are followed • Enforces uniformity and quality • Identifies the source of material if adulteration is discovered
Re Requisitions • Materials and components must come from qualified vendors • Materials and components must have specifications approved by the Quality Unit • All chemicals need a Material Safety Data Sheets (MSDS) on file • Certificate of Analysis (COA) is needed for each material to be used in manufacturing a product • Incoming materials must be same material and same grade as specified on purchase order
Ins Instan antG tGMP P Requis equisitio ition n Screen een Example:
Ma Materi rial R Receipt • Identify each lot # of material received and each lot of manufactured product • Connect the material lot # to the supplier and to each manufactured product
Ins Instan antG tGMP P Batch h Produc ductio tion n Rec ecord • BPR Tabs • Cover Page – Product Description • Materials • Equipment • In-Process Tests • Manufacturing Instructions • BPR Review
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