Good Manufacturing Practices and InstantGMP™ Software Orientation Slides

Topics Batch Production Record Workflow Purchasing Material Receipt Batch Production Inventory Summary Overview Purpose of GMPs Quality Systems GMP Process Flow Master Production Record Workflow Materials Products to be manufactured Specifications Master Production Records Training Overview Training Preparation Scheduling Appointments

InstantGMP Quick Facts 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

FDA Requires SOPs for GMP Compliance

InstantGMP Consulting 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 Must Follow cGMPs?

7 Basic Tenants of GMPs 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 FDA Mantra: “If it wasn’t documented, it wasn’t done!”

Purpose of Good Manufacturing Practices Following FDA requirements for Good Manufacturing Practices Gives you consistent, high quality products

Quality 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

System Generated Numbers

Materials 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

Materials used in manufacturing Default types provided in InstantGMP Part # automatically assigned Material ID captures legacy numbering system

Materials that are manufactured Products used in creating an MPR - Outgoing WIP - Finished Goods

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 product Keep contaminants from adulterating a batch Establish the basis of quality for your final product

Specifications Needed For: Components In-process production Labels and packaging Finished batch of product Packaging and labels Received products

InstantGMP Specification Entry Screen Specifications have to be approved before material can be ordered or used in a batch Example:

InstantGMP Specification Entry Screen Each specification must have tests, methods and acceptance limits Example:

Projects

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 list

Add a WIP/FG to a Project Material Name + Strength + Container + Suffix must be a unique combination for each Product Name Strength, Container and Suffix are optional 3. Create a Product Name

Add / Delete a WIP/FG in a Project Multiple products can be added to any project Product can be modified or deleted up until the product is used in an approved MPR

Creating a new 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

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/Strength Client Formulation ID Theoretical Batch Yield Batch Unit

MPR Status Definitions 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

MPR 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

MPR Version 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

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 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

MPR Summary Screen Summary includes: Cover page Materials to be used Equipment In-process tests Manufacturing instructions MPR approvals

Good Manufacturing Practices and InstantGMP™ Orientation Part Three: Batch Production Record

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 followed Enforces uniformity and quality Identifies the source of material if adulteration is discovered

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

InstantGMP Requisition Screen Example:

Material 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

InstantGMP Batch Production Record BPR Tabs Cover Page – Product Description Materials Equipment In-Process Tests Manufacturing Instructions BPR Review

InstantGMP Batch Production Record Manufacturing Instructions Screen

Distribution Procedures Products should only be shipped out for distribution after they have been released by the quality unit Products should be transported in a way that maintains their quality Special transport or storage conditions should be stated on the label A system should readily permit the recall of a product if needed

Tracking of Inventory Distribution Example:

Summary Good Manufacturing Practices are complex and thorough Wide array of regulatory requirements need to be followed Following GMPs gives you high quality products InstantGMP guides you through the GMP manufacturing process Remember the FDA mantra: “If it wasn’t documented, it wasn’t done!”

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 program Additional paid training is available

Getting Ready for Software Training Download the Join.me desktop App from Note: Make sure to use the computer that will be used during software training. To make your Software Training appointment, go to:

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