2. 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
3. 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
5. 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
7. 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!”
8. Purpose of Good Manufacturing Practices
Following FDA
requirements for Good
Manufacturing
Practices
Gives you
consistent, high
quality products
9. 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
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
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
12. System Generated Numbers
Warehouse Receiving
Purchase Order
Material
Part #
Requisition #
Receipt #
Specification w/Version #
Master Record w/Version #
Batch #
Production
Master Record
Specifications
13. 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
14. Materials used in manufacturing
• Default types
provided in
InstantGMP
• Part # automatically
assigned
• Material ID captures
legacy numbering
system
15. Materials that are manufactured
• Products used in creating
an MPR
- Outgoing WIP
- Finished Goods
16. 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
17. Specifications Needed For:
• Components
• In-process production
• Labels and packaging
• Finished batch of product
• Packaging and labels
• Received products
18. InstantGMP Specification Entry Screen
Specifications have to be approved before material can be
ordered or used in a batch
Example:
21. 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
22. 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
23. 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
24. 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
25. 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
26. 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
27. 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
28. 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
29. 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
30. MPR Summary Screen
• Summary includes:
• Cover page
• Materials to be used
• Equipment
• In-process tests
• Manufacturing instructions
• MPR approvals
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
34. 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
35. 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
37. 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
40. 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
44. 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!”
45. 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
46. Getting Ready for Software 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
software training.
• To make your Software Training appointment, go to:
http://www.instantgmp.com/support/appointment-request
47. Find articles and videos on cGMP compliance and quality
in the Resource Center at
InstantGMP.com
Welcome to our orientation session on InstantGMP. In this session, we will describe some of the important aspects of meeting Good Manufacturing Practices and show how InstantGMP works to reinforce them.
The topics we will cover were selected to give you an appreciation of what is required for GMP compliance and how InstantGMP reinforces the requirements for you. In the first part of this orientation we’ll go into using GMPs and Quality Systems and go over the GMP process flow.
In the second part of this orientation, we will go through the prerequisites needed to create a Master Production workflow. This includes describing the materials needed for manufacturing, describing the products to be manufactured, setting specifications for the materials and creating the Master Production Record.
Then we’ll move to Batch Production Records, we will follow the typical route that a material goes though in a manufacturing environment, from the time it is purchased and received until the time it is used in manufacturing the final product. We will then follow the product as it is entered into inventory and then shipped out the door.
First, let’s start with some quick facts about InstantGMP. This is cloud-based software accessed from your internet browser. As long as you have an internet connection, it can be accessed anywhere. It was originally developed by a team of GMP manufacturing and quality experts who worked hand-in-hand with the software developer to ensure that the best practices of manufacturing were incorporated into the software.
InstantGMP is in compliance with the pharmaceutical industry standards for software validation. It meets the 21 CFR part 11 requirements for electronic documentation and is in compliance with GAMP 5 and FDA validation requirements. InstantGMP has been in use since 2004 and is continually updated in our constant effort to make GMP manufacturing easier.
Coming into compliance with Good Manufacturing Practices is not easy when someone is just getting started. The FDA requires SOPs for compliance, but the regulations are written in very general terms so they have to be interpreted for each type of manufacturing operation. The interpretation shows up in the policies and standard operating procedures that are written by or for the manufacturing company.
InstantGMP makes several sets of SOPs available to meet the needs of different types of companies. Be sure to check out our website page on SOPs for more information and see what sets are available for purchase.
InstantGMP also provides consulting services when companies need help with moving to electronic manufacturing or with GMP compliance.
Our Process Consultants can provide help in making the transition from manual systems to electronic batch records and in creating company specific Master Production Records. Sometimes they will map a company’s work flow to show how InstantGMP can make them more efficient.
Our GMP Consultants can be used to assist in understanding GMP requirements or to provide help in developing a quality system for a manufacturing site. They can advise on setting specifications and in choosing tests and methods for raw materials and finished products. If needed, they can teach a GMP 101 course or provide annual GMP training.
Each software license receives a certain amount of included process consulting hours. Be sure to look over your year to year agreement for the specifics. Additional hours are available for a separate hourly rate. The software, with SOPs and consulting, lays for the foundation of a total quality system.
There are different GMP standards for different industries, but anyone who manufactures products regulated by the FDA must meet their respective standards. Drug and Medical Device firms manufacture products that are used in the diagnosis or treatment of a disease. Dietary Supplements firms manufacture orally delivered ingredients that are intended to supplement the diet. Food and Cosmetics companies must meet their own version of Good Manufacturing Practices. E-Liquid manufacturers now have their own set of regulations to follow.
The basics of current Good Manufacturing Practices starts with documentation. The FDA says “If it wasn’t documented, it wasn’t done”. Other important tenants of GMP include making sure instructions and procedures are clear and unambiguous, that manufacturing processes are clearly defined and controlled, that facilities are designed to minimize cross-contamination and mix-ups. You have to make sure that your operators are trained and that records demonstrate that all required steps were taken. You need to ensure that distribution minimizes any risk and that your manufacturing is governed by a Quality System.
The purpose of using Good Manufacturing Practices is fairly straightforward. If you follow FDA requirements for Good Manufacturing Practices, you wind up with a quality system that promotes making consistent, high quality products. This ensures your customer get products from you that they can trust.
I’ve mentioned the word quality a lot, but what is quality? Any discussion of Good Manufacturing Practices has to start with its definition. The term “Quality System” or “Quality” is often misinterpreted by customers who tend to associate quality as a characteristic of a product that costs more. In their words, if it costs more than it must have a higher quality. The definition is much simpler. Quality can be defined as meeting specifications. These are the standards a product must meet to show that it was made in a consistent and acceptable way.
Quality Control is the organization that does the testing to ensure specifications are met.
Quality Assurance is the organization or processes for the review of testing results and promotion of practices intended to ensure quality.
The Quality System is the collection of policies, standard operating procedures and other documentation that define the practices needed to ensure quality.
All GMP manufacturers are required to write and manage Master Production Records (MPR) and Batch Production Records (BPRs) in order to comply with FDA regulations. Our software was designed around keeping you in compliance with these regulations through our electronic batch records. The Master Record is different from the Batch Record in one significant way, the Batch Record is a copy, or a child product of the Master Record. The Batch Record is where you can document the when, how, by whom a product was produced. This ensures that multiple batches made from copies of the Master will be uniform and will meet its anticipated requirements. This is one of the fundamentals of quality in manufacturing.
This diagram illustrates the steps needed to create a master and then a batch record.
A typical work flow to get to a Master Production Record is shown on the left side. Master Production Records, also known as Master Manufacturing Formulas and Master Batch Records, are documents that include the manufacturing instructions that will be followed during Batch Production. Think of a Master Batch Record as a plan that has to have Quality approval that ensures each batch you make will be done properly.
The Batch Production Record work flow is on the right side of this diagram. These steps include requisitioning the purchasing of some materials, receiving them into inventory, updating their status to “Approved” and generating a Batch Production Record. That is when you will actually manufacture your product.
During your software training, you will be guided step by step through the prerequisites needed to create a master production record. You will enter some personnel, several vendors and some materials and a product for training purposes. You will then create specifications for each material and your product. Then you can create your first MPR. When you finish writing the Master Production Record, you will guided through the prerequisite steps needed to create a Batch Production Record.
The Master Production Record work flow begins with identifying the materials and products that will be used or made in the facility. InstantGMP manages the types and statuses for you. The vendors that will supply raw materials, ingredients and components can be entered into the system. InstantGMP has separate SOPs that guide the qualification of those vendors. Every material that will used in a product as well as each finished product has to have specifications. Specifications describe the characteristics of a material and how to test that material to ensure that it meets your quality requirements. Our software will manage these specifications and automatically track version numbers.
InstantGMP automatically generates numbers that keep your information organized and ensures you meet GMP regulations. It creates a unique Part # for every material that is entered into the system, generates a receipt # when materials are ordered, and connects that receipt with the received vendor lot to the material; providing that full connectivity and traceability. Unique Master Production Record numbers are assigned automatically.
Let’s take a more detailed look at Materials. In InstantGMP, we provide two classifications of materials to make it easy to manage them. The first classification is for materials used in manufacturing. These include Raw Material, Incoming Work in Process, and other materials such as supplies. An Incoming WIP is usually something you buy and then use in the manufacturing process.
The second classification if for materials that are manufactured. This includes Outgoing Work in Process and Finished Goods. These are typically made to be sold. An Outgoing WIP could be something that is sold directly to a customer or is made in your plant and then used as a component in a finished good elsewhere. Each Classification has its own unique input screen where you can define each material separately.
If you are a new customer who already has a list of materials, let your InstantGMP trainer know and they will arrange to have that list imported for you.
There are many types of these materials and a default list is provided to help you keep them organized. InstantGMP will automatically assign a part # to each material when it is entered into the system. If you have your own way of identifying your materials in a legacy system, you can enter that in the Material ID field to associate your identifies with the InstantGMP Part #.
Materials that are manufactured include Outgoing Work In Process and Finished Goods. These are the products you will plan to manufacture when you create a Master Production Record.
Information that was entered at the setup submenus will auto-populate the drop downs. For example, if you entered ambient as a storage condition, you will be able to select it here.
If you enter the cost per unit, it will appear when you requisition this material.
Specs make sure you are getting the right materials from your vendors. They allow you to verify identity, purity, strength and composition and keep contaminants from adulterating a batch. InstantGMP will manage these specifications and automatically track version numbers.
Specifications are needed for anything that will be in the final product, that was used in the manufacturing of the final product or that touches the final product. This includes components, in-process production, labels and packaging, the finished batch and the packaging and labels. They are also needed for products or Incoming WIP received from a supplier where you are just going to do the packaging and labeling.
InstantGMP provides an automated method of creating specifications and keeping track of their different versions. They also include the safety and handling instructions for operators and the sampling instructions for quality
Since InstantGMP is designed to follow the work rules of Good Manufacturing Practices, it will require specifications to be developed and approved before materials can be ordered or used in production. A specification is a list of the tests, the analytical methods and the acceptance ranges that you use to make sure you get the quality you want. Specifications describe the characteristics of a material and how to test that material to ensure that it meets your quality requirements.
Projects are a convenient way to keep Finished Goods/Outgoing WIPs, Clients and Personnel organized. Each project can have multiple products, multiple clients, multiple personnel and multiple roles for each person. The Project Titles and assigned Products will be available via dropdown when you go to create a Master Production Record.
The first step is to name the Project and provide a description. Then, we add a WIP or FG to the Project. To do this you will select a Material name from the Product Name Selection List. Only materials that are classified as Finished Goods or outgoing WIP will show on this list. This is the product that you will be manufacturing.
The next step is to create a Product Name. The Product Name is the combination of the material name, strength, container and suffix. Any of the strength, container and suffix fields can be left blank. Each product name combination can be used only once so each combination has to be unique. This is unrelated to the name of the project.
Multiple products can be added to any project, however, the product can be only modified or deleted up until the product is used in an approved MPR.
We are now at the point where a new Master Production Record can be created. You will select the project title from the first drop down and the product name from the update arrow. The information pulled from that project will populate. The clients on this project are the only ones that are selectable. Theoretical batch yield is what you’re expecting to manufacture, aka the size of the batch. It differentiates from the batch size in that it accounts for sampling, rejects, and losses. A primary container is selectable, and you can enter the amount per container.
If you select the auto-populate BOM QTY on MFG instructions, it will add the step of weighing the materials before their use and is instrumental when scaling a batch up or down. Essentially, it’s optional, but if you want to be able to scale this batch, you will need to have it checked.
A version of an MPR has specific characteristics. Every version of an MPR will have the same Product Name, Strength, Client, Formulation ID, Theoretical Batch Yield and Batch Unit. If a subsequent MPR is a new version, those fields will remain the same. All fields in a versioned up MPR can be edited except the ones shown here. This is in line with the norms for GMP manufacturing.
Every Master Production Record will have status that will change as the MPR changes. When an MPR is first created, it is In-Progress until an approver applies their digital signature. At that point the MPR is Locked. When all the approvals are completed, the MPR is in the Approved status. If any approver rejects, the MPR, the Status will be Rejected.
A copy can be made from any approved or rejected Master Production Record. The copy is identical in every way to the MPR with one exception: at least one of the following have to change: Product Name, Strength, Client, Formulation ID, Theoretical Batch Yield or Batch Unit. Otherwise it is not a copy, but a new version of an existing MPR.
Versioning up is the act of making a complete copy of an Approved or Rejected MPR. All of the information is copied and is editable except the following: Product Name, Strength, Formulation ID, Theoretical Batch Yield & Unit, and the Bill of Materials. A new required field labeled “Reason for Change” will appear on MPR Cover page.
InstantGMP allows you to quickly and accurately scale up or scale down a batch in a copy of an Approved or Rejected MPR. Where the BOM QTY is checked can be scaled. The copy is identical to the original MPR with one exception that at least the Theoretical Batch Yield has to change. When a new value is entered, the quantities in the Bill Of Materials and in the manufacturing instructions will be automatically recalculated based on new Theoretical Batch Yield. Since the Theoretical Yield changes, the new MPR Version will be 1 and the MPR will be unique.
A completed Master Production Record summary is shown here. It includes tabs that contain the information for the Product Description, Bill of Materials, Equipment, In-Process Tests, Manufacturing Instructions and Approvals. Once an MPR is approved it is locked down and cannot be edited. It can, however, be used to generate a Batch Production Record.
Now that you have seen the steps necessary to create a Master Production Record, we can go through the steps needed to get ready to manufacture using a Batch Production Record. These steps include purchasing some materials, receiving them into inventory, updating their status to approved and generating a Batch Production Record. At that point the process of actually manufacturing something begins. When manufacturing is done, the product is added into inventory and is then available for quality testing and eventually for sale to your customers.
Welcome to our orientation session on InstantGMP. In this session, we will describe some of the important aspects of meeting Good Manufacturing Practices and show how InstantGMP works to reinforce them.
Welcome to our orientation session on InstantGMP. In this session, we will describe some of the important aspects of meeting Good Manufacturing Practices and show how InstantGMP works to reinforce them.
Batch production records are needed to document when each batch was produced, what lots of raw materials and ingredients were used in that batch and that the product was made in compliance with the master production record.
The batch record must show that any deviations that occurred during manufacturing were investigated and resolved. These requirements will allow uniform batches that meet established quality requirements and specifications. A good batch record system keeps track of raw materials and ingredients that went into a batch and so if a problem occurs, it makes it easy to find a root cause, which can prevent problem from reoccurring.
Before you start to requisition or purchase a material or component, you should make sure your materials come from a qualified vendor and the specifications were approved by your Quality Unit. InstantGMP will check for approved specifications for you. Material Safety Data Sheets should be on file for each chemical, raw materials and ingredient at the site where they are stored or used. Certificates of Analysis are needed for every material or component that will be used in a final product. Every incoming material should be checked to make sure it is consistent with its corresponding purchase order.
InstantGMP requisitions let you select your vendors and the materials that you will order from them. InstantGMP will automatically convert from one measurement system to another, for example, kgs to lbs or gallons to liters. If you input the cost per unit at the material screen, it will appear here for you.
For each material that you receive, you have to identify a unique lot within each unique shipment of components. You have to be able to trace the lot # to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected), and to the product that you manufactured and distributed. InstantGMP automatically connects the Part # of the material received with that materials Lot # and with a unique Receipt #. That way it can take care of tracking each material that is received into the system. The assigned Receipt # follows that specific material throughout its use in production.
A Batch Production Record summary is shown here. It includes tabs that contain the information for the Product Description, Bill of Materials, Equipment, In-Process Tests, Manufacturing Instructions and Signature Reviews. Once it is issued by QA, it can be used for batch manufacturing.
This is an example of the screen that operators will use to enter their results during batch production. In this example, it automatically shows the name, part #, Vendor Lot # and quantity of the material that was staged in the production area. If a comment is entered into the deviation field, a separate QA signature will be needed for the batch to be completed.
In this last part of production, we will talk about distribution and how materials and finished goods should be tracked once a product has been manufactured and shipped out. Good Manufacturing Practices describes the procedures needed during and after distribution. Products should only be shipped out for distribution after they have been released by the quality unit. Products should be transported under conditions that maintains their quality. For example, if a product will degrade in the heat, it should be shipped in refrigerated or cooled containers. If there are special transport or storage conditions necessary, these should be stated on the label. Also, a tracking system should be in place whereby the location and the history of any product can be readily determined in order to permit its recall. InstantGMP generates records for vendor lot and batch lot traceability for this purpose.
InstantGMP allows for tracking inventory and maintaining a history of it distribution. Each time some material is used up, a record of use, the amount used and purpose is entered. This information is available on-line so it is easy to keep track of where the inventory is located and how it was used.
The Production Lot Traceability Report will show which component lots were used in any specific batch.
If any component lot is identified as having issues or was used in a finished product that was recalled, the Vendor Lot Traceability report that can identify all of the production batches where that component lot was used.
To summarize, the FDA requirements for Good Manufacturing Practices are complex and thorough. There are a wide array of regulatory requirements that need to be followed. The good news it that following GMPs results in high quality products and InstantGMP is there to guide you through the GMP manufacturing process. Just Remember the FDA mantra: “If it wasn’t documented, it wasn’t done!”
At this point you have completed the orientation to InstantGMP. The next step is the training plan is the Software Training. This training is an interactive introduction of the InstantGMP software and will take 4 to 6 hours. It will be given to the Project Manager (PM) and Quality Manager (QM) who have been selected for this training.
If your company has not yet done so, please have them designate one Project Manager and one Quality Manger who can commit to the full training program. This must be done ahead of your software training appointment. Failure to do so will result in having to select a new appointment slot. Please fill in this information on the appointment calendar when prompted.
To make your Software Training appointment, go to: http://www.instantgmp.com/support/appointment-request
We use the full functionality of Join Me during this training. Participants will often have to change presenter roles and allow trainer access to mouse functions. Thus, we do require Join Me to be installed on your computer. To get ready for the software training, download the Join.me desktop App from http://www.InstantGMP.com/joinme
Make sure to set up the join.me on the computer that will be used during software training prior to your appointment. Not doing so ahead of time may result in the trainer ending the appointment and have you reschedule. In that case, you will lose those 2 hours as training time and will need to wait 72 hours for a new appointment.
Thanks for your attention and participation today. If you want to learn more about GMP compliance and quality, you find many articles and videos on these topics in the Resource Center at InstantGMP.com.
