Good Manufacturing Practices and InstantGMP Overview

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

InstantGMP Quick Facts Web application hosted in the cloud Team of GMP manufacturing and quality experts used to guide software development 21 CFR Part 11, GAMP 5 and FDA validation requirements met Standard Operating Procedures for a GMP facility and software written as part of the software development Software has been in use since 2004

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

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

Implementing Good Manufacturing Practices from Start to Finish FDA Requirements Consistent, high quality products Quality System GMP Interpretation Policies and SOPs Traini ng

FDA Requires SOPs for GMP Compliance

InstantGMP SOP Sets Full Set 93 SOPs and Policies that provides a quality system for any GMP manufacturing site Core set 30 SOPs and Policies cover the basics of manufacturing with InstantGMP™ MES Holding and Distribution Set 65 SOPs and Policies that provides a quality system for any Holding and Distribution company that must comply with GMPs

Who Must Follow cGMPs? Drugs and Medical Devices Dietary SupplementsFood and Cosmetics Firms that manufacture and send out for packaging and labeling or import for sale any product that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body Firms that manufacture and send out for packaging and labeling or import for sale any dietary supplement product Does not apply to dietary ingredients Food processors and distributors Firms that manufacture, package or label cosmetics

10 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!”

Three Components of a Quality System are: Policies - Describe what is needed to be in GMP compliance Standard Operating Procedures – Implement the workflow required by the policies Documentation required by SOPs - Record in InstantGMP

Quick Discussion Are any of these concepts new to you? What do you think using a quality system will do for you personally?

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Good Manufacturing Practices and InstantGMP Master Production Record Workflow

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 -Finished Good -Outgoing WIP

Specifications Establish the basis of quality for your final product Make sure you are getting the right materials from your vendors Ensure you have the right ingredients in the product Keep contaminants from adulterating a batch Allow you to verify identity, purity, strength and composition

Specifications Needed For: Components In-process production Labels and packaging Finished batch of product Packaging and labels Product you receive from a supplier for packaging and labeling

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

Master Production Record MPR Tabs Cover Page – Product Description Materials Equipment In-Process Tests Manufacturing Instructions MPR Approvals

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Good Manufacturing Practices and InstantGMP Batch Production Record Workflow

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

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

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

InstantGMP Batch Production Record Instructions Screen

Quick Discussion Does your company have both master records and batch records? What do you see might be a challenge in using electronic batch records?

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!”

Quick Discussion What concepts have you learned that you weren't aware of before? What part of InstantGMP do you anticipate you will need support to implement?

Next Training Sessions Software Training (2 hours) – An interactive introduction of the InstantGMP software to the Project Manager (PM) and Quality Manager (QM). Product specific or company specific questions will be addressed during the Dry Run. Dry Run Preparation - An instruction session where PM and QM will learn about naming conventions and what information is needed to fill out the Dry Run Preparation spreadsheet. Dry Run (2 X 2 hours) –The PM and QM will draft a Master Production Record and practice manufacturing the product from the Dry Run Spreadsheet. This will prepare the PM and QM to enter products on their own.

Training Scheduling Designate one Project Manager and one Quality Manger who can commit to the full training program. These are the only people who will receive Software Training and Dry Run practice Training so they will need to attend all technical training sessions. Your subscription includes these 8 hours of training time If scheduled training needs to be changed, let us know 24 hours in advance, otherwise scheduled hours will be charged to your 8 hours of training time If more than 8 hours is needed or more than 2 technical trainees need training, an invoice for $349 for each 2 hour session will have to be paid in advance

Getting Ready for Technical Training Download the Join.me desktop App from Note: Make sure to use the computer that will be used during technical training. This computer should be used for Software and Configuration Training. Note: Windows and Firefox are required (or Macs set to windows mode)

Join.me Meeting - Remote Training You can share mouse control with your instructor so he/she can demonstrate functions of the software. Click the drop down on the right side of the menu and click “Share mouse control”.

Join.me Meeting - Remote Training Your instructor may ask you to return the presenter role. If so, click the drop down on the right side of the menu and click “Pass presenter role”.

Join.me Meeting - Remote Training When the session is over, you can select the drop down and click “Exit this meeting” either as a presenter (orange menu) or a participant (green menu).

Find articles and videos on cGMP compliance and quality in the Resource Center at InstantGMP.comInstantGMP.com

TITLE:NUMBER:EFFECTIVE DATE: InstantGMP OrientationTRN See Version History VERSIONEFFECTIVE DATEDESCRIPTION OF CHANGE 00New 01 Superseded by version 02 02Updated to InstantGMP v Further updates to reflect new changes in v2.052 VERSION HISTORY APPROVALSTITLESIGNATURE/DATE Reviewed By: Richard SolteroPresident Reviewed By: Patrick StauntonTrainer Approved By: Gretchen RizorQuality Assurance APPROVAL BLOCK