Good Manufacturing Practices and InstantGMP Overview

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 Practicesfrom Start to Finish

FDA Requirements

Consistent, high quality products

Quality System

GMP Interpretation

Policies and SOPs

Training

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

DevicesDietary Supplements Food and

CosmeticsFirms 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!”

Good Manufacturing Practices Work Flows Reinforced in InstantGMP

Enter products to be manufactured

Enter materials needed for manufacturing

Establish material and product specifications

Requisition materials and components

Receive materials into inventory and approve for use

Prepare Master Production Record Add batch to inventory

Master Production Record Work Flow

Generate Batch Production Record

Batch Production Record Work Flow

Organize Products into Projects Capture production data

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?

Find articles and videos on cGMP compliance and quality in the Resource

Center at InstantGMP.com

Good Manufacturing Practices and InstantGMP

Master Production Record Workflow

Good Manufacturing Practices Work Flows Reinforced in InstantGMP

Enter products to be manufactured

Enter materials needed for manufacturing

Establish material and product specifications

Requisition materials and components

Receive materials into inventory and approve for use

Prepare Master Batch Record

Add batch to inventory

Master Production Record Work Flow

Generate Batch Production Record and capture production data

Batch Production Record Work Flow

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

System Generated Numbers

Warehouse Receiving

Purchase Order

Material

Part #

Requisition #

Receipt #

Specification w/Version #

Master Record w/Version #

Batch #

Production

Master Record

Specifications

InstantGMP automatically assigns

and tracks Part #s

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

Spec

ifica

tions

Needed

Fo

r:

•Com

ponents

•In-process production

•Labels and packaging

•Finished batch of product

•Packaging and labels

•Product you receive from

a supplier for packaging and labeling

System Generated Numbers

Warehouse Receiving

Purchase Order

Material

Part #

Requisition #

Receipt #

Specification w/Version #

Master Record w/Version #

Batch #

Production

Master Record

Specifications

InstantGMP automatically adds specification version

numbers

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 UnitDefinitions 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

Find articles and videos on cGMP compliance and quality in the Resource

Center at InstantGMP.com

Good Manufacturing Practices and InstantGMP

Batch Production Record Workflow

Good Manufacturing Practices Work Flows Reinforced in InstantGMP

Enter products to be manufactured

Enter materials needed for manufacturing

Establish material and product specifications

Requisition materials and components

Receive materials into inventory and approve for use

Prepare Master Batch Record

Add batch to inventory

Master Production Record Work Flow

Generate Batch Production Record and capture production data

Batch Production Record Work Flow

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

System Generated Numbers

Warehouse Receiving

Purchase Order

Material

Part #

Requisition #

Receipt #

Specification w/Version #

Master Record w/Version #

Batch #

Production

Master Record

Specifications

InstantGMP automatically

connects Part #, Lot # and Receipt #

Why

Ba

tch

Re

co

rds

ar

e

Impo

rtan

t

•Show

s when product w

as produced

•D

ocuments actual tim

es of procedures and am

ounts of m

aterials used; etc.

•Assures consistency in how

processes are follow

ed

•Enforces uniform

ity and quality

•Identifies the source of m

aterial if adulteration is discovered

InstantGMP automatically

assigns Batch #s

System Generated Numbers

Warehouse Receiving

Purchase Order

Material

Part #

Requisition #

Receipt #

Specification w/Version #

Master Record w/Version #

Batch #

Production

Master Record

Specifications

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 DistributionExample:

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

http://www.InstantGMP.com/joinme

• 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.com

TITLE: NUMBER: EFFECTIVE DATE:

InstantGMP Orientation TRN-1000.03-2.052 See Version History

VERSION EFFECTIVE DATE DESCRIPTION OF CHANGE00 New

01 Superseded by version 02

02 Updated to InstantGMP v2.052

03 Further updates to reflect new changes in v2.052

VERSION HISTORY

APPROVALS TITLE SIGNATURE/DATE

Reviewed By: Richard Soltero President

Reviewed By: Patrick Staunton Trainer

Approved By: Gretchen Rizor Quality Assurance

APPROVAL BLOCK