Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP - - PowerPoint PPT Presentation

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Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP - - PowerPoint PPT Presentation

Mar 03, 2023 159 likes •660 views

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

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SLIDE 1

Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™

Soft Softwar are Orie ientation ion Slid Slides

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SLIDE 2

To 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

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SLIDE 3

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
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SLIDE 4

FD FDA Requir equires es SOPs for GMP P Complianc pliance

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SLIDE 5

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
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SLIDE 6

Who Who Mus ust Follow w cGMPs? s?

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SLIDE 7

7

Ba Basic Tenants of

  • f GM

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!”

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SLIDE 8

Pu Purpose of Good Manufacturing Pr Practices

Fo Following FDA re require rements for Good Ma Manufacturi ring Pr Practices

Gi Gives s you co consistent nt, high qua quality pr product ducts

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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
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SLIDE 10

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

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SLIDE 11

Enter products to be manufactured Enter materials needed for manufacturing Establish material and product specifications Prepare Master Production Record

Master Production Record Work Flow

Organize Products into Projects

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SLIDE 12

Sy System Generated Numbers

Warehouse Receiving Purchase Order Material

Part # Requisition # Receipt # Specification w/Version # Master Record w/Version # Batch #

Production Master Record Specifications

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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
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SLIDE 14

Ma Materi rials u used i in ma manufacturi ring

  • Default types

provided in InstantGMP

  • Part # automatically

assigned

  • Material ID captures

legacy numbering system

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SLIDE 15

Ma Materi rials t that a are ma manufactured

  • Products used in creating

an MPR

  • Outgoing WIP
  • Finished Goods
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SLIDE 16

Sp Speci cification

  • ns
  • 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
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SLIDE 17

Sp Speci cification

  • ns Ne

Needed F For:

  • r:
  • Components
  • In-process production
  • Labels and packaging
  • Finished batch of product
  • Packaging and labels
  • Received products
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SLIDE 18

Ins Instan antG tGMP P Spec pecif ific icatio tion n Entr try Screen een

Specifications have to be approved before material can be

  • rdered or used in a batch

Example:

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SLIDE 19

Ins Instan antG tGMP P Spec pecif ific icatio tion n Entr try Screen een

Each specification must have tests, methods and acceptance limits Example:

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SLIDE 20

Pr Projects

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SLIDE 21

Ad 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

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SLIDE 22

Ad 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
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SLIDE 23

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

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SLIDE 24

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

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SLIDE 25

MP MPR V Version

  • ning
  • 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
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SLIDE 26

MP MPR St Status D Definition

  • ns
  • 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
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SLIDE 27

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
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SLIDE 28

MP MPR V Version

  • n 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

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SLIDE 29

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
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SLIDE 30

MP MPR Su Summa mmary Sc Screen

  • Summary includes:
  • Cover page
  • Materials to be used
  • Equipment
  • In-process tests
  • Manufacturing instructions
  • MPR approvals
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SLIDE 31

Batch Production Record Work Flow

Requisition materials and components Receive materials into inventory and approve for use Add batch to inventory Generate Batch Production Record Capture production data

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SLIDE 32

Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™

Orientation Part Three: : Batch Pr Production Record

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SLIDE 33

Go Good Ma Manufacturi ring Practices and Ins and Instan antGMP™ P™

Orientation Part Three: : Batch Pr Production Record

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SLIDE 34

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
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SLIDE 35

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

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SLIDE 36

Ins Instan antG tGMP P Requis equisitio ition n Screen een

Example:

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SLIDE 37

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

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SLIDE 38

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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SLIDE 39

Ins Instan antG tGMP P Batch h Produc ductio tion n Rec ecord d Ma Manufacturi ring I Instru ruction

  • ns Sc

Screen

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Dis Distrib ibutio ion P Proce cedures

  • 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
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SLIDE 41

Tr Tracking of Inventory Distribution

Example:

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SLIDE 42
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SLIDE 43
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SLIDE 44

Su Summa mmary

  • 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!”

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SLIDE 45

Ne Next – Sof Software T 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
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Ge Gettin ting Read ady for Softw twar are Train ainin ing

  • Download the Join.me desktop App from

http://www.InstantGMP.com/joinme

  • Note: 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-request

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SLIDE 47

Fi Find articl cles s and videos s on cGM cGMP compliance ce and quality y in the Resource Center at In InstantGMP MP.com

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SLIDE 48

Batch Record Batch Record Batch Record Master Record