Software Orientation Slides Topics Batch Production Record Workflow Purchasing Material Receipt Batch Production Inventory Summary Overview Purpose of GMPs Quality Systems GMP Process Flow ID: 570816
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Good Manufacturing Practices and InstantGMP™
Software Orientation SlidesSlide2
Topics
Batch Production Record Workflow
Purchasing Material ReceiptBatch ProductionInventorySummary
OverviewPurpose of GMPsQuality SystemsGMP Process Flow
Master Production Record WorkflowMaterialsProducts to be manufacturedSpecificationsMaster Production Records
Training Overview
Training Preparation
Scheduling AppointmentsSlide3
InstantGMP Quick Facts
Cloud-based
Team of GMP manufacturing and quality
experts used to guide software development21 CFR Part 11, GAMP 5 and FDA validation requirements metSoftware has been in use since 2004Slide4
FDA Requires SOPs for GMP ComplianceSlide5
InstantGMP Consulting
Process
ConsultingHelp in making the transition from manual systems to electronic batch recordsCreate company specific Master Production Records (MPR)Map company specific process flows
GMP ConsultingAssist in understanding GMP requirementsHelp in developing a quality system for a manufacturing siteAdvise on setting specifications and choosing tests and methods for raw materials and finished products Teach GMP 101 course or annual GMP trainingSlide6
Who Must Follow cGMPs?Slide7
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Basic Tenants
of
GMPs Instructions and procedures are clear and unambiguousManufacturing processes are clearly defined and controlled Facilities are designed to minimize cross-contamination and mix-upsOperators are trainedRecords demonstrate that all required steps were taken Distribution minimizes any riskManufacturing is governed by a Quality System consisting of Policies and SOPsFDA Mantra: “If it wasn’t documented, it wasn’t done!”Slide8
Purpose of Good Manufacturing Practices
Following FDA requirements for Good Manufacturing Practices
Gives you consistent, high quality productsSlide9
Quality System
Quality = meeting specifications
Quality Control = testing to ensure specifications are metQuality Assurance = review of testing results and promotion of practices intended to ensure qualityQuality 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 systemSlide10Slide11Slide12
System Generated NumbersSlide13
Materials
Two classifications of materials:
Materials used in manufacturingRaw MaterialIncoming WIPOtherMaterials that are manufactured
Outgoing WIPFinished GoodsEach Classification has a different input screenSlide14
Materials used in manufacturing
Default types provided in InstantGMP
Part # automatically assigned
Material ID captures legacy numbering systemSlide15
Materials that are manufactured
Products used in creating an MPR
- Outgoing WIP - Finished Goods Slide16
Specifications
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 productKeep contaminants from adulterating a batchEstablish the basis of quality for your final productSlide17
Specifications Needed For:
Components
In-process production
Labels and packagingFinished batch of productPackaging and labelsReceived productsSlide18
InstantGMP Specification Entry Screen
Specifications have to be approved before material can be ordered or used in a batch
Example:Slide19
InstantGMP Specification Entry Screen
Each specification must have tests, methods and acceptance limits
Example:Slide20
ProjectsSlide21
Add a WIP/FG to a Project
1. Click Add WIP/FG Part #
2. Select a Material Name
Only FG and oWIP (outgoing WIP)show in the listSlide22
Add a WIP/FG to a Project
Material Name + Strength + Container + Suffix must be a unique combination for each
Product NameStrength, Container and Suffix are optional
3. Create a Product NameSlide23
Add
/ Delete a
WIP/FG in a ProjectMultiple products can be added to any projectProduct can be modified or deleted up until the product is used in an approved MPRSlide24
Creating a new MPR
Project/Product/Client combination creates flexibility
Strength is inherited from Product NameBatch Unit is inherited from TmaterialUnique for each MPR lineage of versionsProduct Name/Strength
ClientFormulation IDTheoretical Batch YieldBatch UnitDefinitions of “Theoretical Batch Yield” and “Batch Size” added Slide25
MPR Versioning
Each new
MPR version will be a copy that can be edited except for the following that will be kept constant:Product Name/StrengthClientFormulation IDTheoretical Batch YieldBatch UnitSlide26
MPR Status Definitions
Approved
All approvers signedBRP can be made from MPRIn-ProcessNo approvers signedMPR can still be edited
LockedAt least one approver, but not all signedRejectedOne approver rejected MPRSlide27
MPR Copy
Only Approved or Rejected MPRs can be copied
All information is copied and is editableAt least one of the following must change (to qualify as a copy not a version up):Product NameStrength
Formulation IDTheoretical Batch YieldBatch UnitSlide28
MPR Version Up
Only Approved or Rejected MPRs can be “Versioned Up”
All information is copied and is editable except the following:Product NameStrengthFormulation IDTheoretical Batch Yield & Unit
Materials“Reason for Change” is required field on MPR Cover pageSlide29
MPR Scale Up/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 NameStrengthFormulation ID
Batch UnitMaterialsQuantities in BOM and mfg instructions will be calculated based on new Theoretical Batch YieldsVersion will be 1 and MPR will be uniqueSlide30
MPR Summary Screen
Summary includes:
Cover pageMaterials to be usedEquipmentIn-process testsManufacturing instructionsMPR approvalsSlide31Slide32
Good Manufacturing Practices and InstantGMP™
Orientation Part Three: Batch Production RecordSlide33
Good Manufacturing Practices and InstantGMP™
Orientation Part Three: Batch Production RecordSlide34
Why Batch Records are Important
Shows when product was produced
Documents actual times of procedures and amounts of materials used; etc.
Assures consistency in how processes are followedEnforces uniformity and qualityIdentifies the source of material if adulteration is discoveredSlide35
Requisitions
Materials and
components must come from qualified vendorsMaterials and components must have specifications approved by the Quality UnitAll chemicals need a Material Safety Data Sheets (MSDS) on fileCertificate 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 orderSlide36
InstantGMP Requisition Screen
Example:Slide37
Material Receipt
I
dentify each lot # of material received and each lot of manufactured productConnect the material lot # to the
supplier and to each manufactured productSlide38
InstantGMP Batch Production Record
BPR Tabs
Cover Page – Product Description
MaterialsEquipmentIn-Process TestsManufacturing InstructionsBPR ReviewSlide39
InstantGMP Batch Production Record Manufacturing Instructions ScreenSlide40
Distribution Procedures
Products should only be
shipped out for distribution after they have been released by the quality unitProducts should be transported in a way that maintains their qualitySpecial transport or storage conditions should be stated on the labelA system should readily
permit the recall of a product if neededSlide41
Tracking of Inventory Distribution
Example:Slide42Slide43Slide44
Summary
Good Manufacturing Practices are
complex and thorough
Wide array of regulatory requirements need to be followedFollowing GMPs gives you high quality productsInstantGMP guides you through the GMP manufacturing processRemember the FDA mantra: “If it wasn’t documented, it wasn’t done!”Slide45
Next – Software Training
4-8 hour interactive
introduction to the InstantGMP software Familiarizes the Project Manager (PM) and Quality Manager (QM) with the workflows Designate one Project Manager and one Quality Manger who can commit to the full training
programAdditional paid training is availableSlide46
Getting Ready for Software Training
Download the
Join.me desktop App from http://www.InstantGMP.com/joinmeNote:
Make sure to use the computer that will be used during software training. To make your Software Training appointment, go to:http://www.instantgmp.com/support/appointment-requestSlide47
Find articles and videos on cGMP compliance and quality in the Resource Center at
InstantGMP.comSlide48