Good Manufacturing Practices and InstantGMP Orientation

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

3 Topics Purchasing Material Receipt Master Production Records Batch Records Storage and Distribution Summary Purpose of GMPs Quality Systems GMP Process Flow Materials Vendor Qualification Specifications

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

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

6 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

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 FDA Mantra: “If it wasn’t documented, it wasn’t done!”

FDA Requirements Good Manufacturing Practices InstantGMP Workflows, Policies and SOPs

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

10 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

Material Controls

12 Material Controls Need written procedures for material receipt, identification, storage, handling, sampling and distribution Need to have specifications and to be purchased only from approved vendors or suppliers Need to track materials throughout warehouse and production Relevant SOPs: POL-303 Material Control SOP-300 Specifications SOP-302 Material Types SOP-304 Material Status SOP-305 Material Sampling SOP-308 Part # Assignment

14 InstantGMP Material Screen InstantGMP ensures materials are in compliance with SOPs Example:

Vendors

16 Vendor Qualification Qualification of all suppliers including components, ingredients and labels Periodic audits and re-qualifying of vendors Confirmation of vendor's test results and COAs Review of specifications, procedures, and lab controls Regular review of vendor’s documentation Relevant SOPs: POL-0203 Service Provider Policy POL-0302 Vendor Selection and Qualification POL-0510 Quality Audits SOP-203 Quality Agreement Preparation SOP-212 Program to Qualify Vendors

17 InstantGMP Vendor Entry Screen Example: Vendors should be audited prior to ordering materials from them

18 Quick Discussion How does your firm currently qualify suppliers and vendors?

Specifications

20 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 Relevant SOPs:SOP-215 TestsSOP-216 MethodsPOL-0307 Purchasing Requirements SOP-300 SpecificationsSOP-305 Material Sampling

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 needs tests, methods and acceptance limits Example:

Requisitions

26 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 Incoming materials must be same material and same grade as specified on purchase order

27 InstantGMP Requisition Screen Example: Relevant SOPs: POL-0302 Vendor Selection and Qualification POL-0307 Purchasing Requirements SOP-100 Purchase Requisition

Material Receipt

29 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 Relevant SOPs: POL-0303 Material Control SOP-302 Material Types SOP-303 Material Receipt SOP-304 Material Status SOP-305 Material Sampling SOP-306 Material Inventory Control and Reconciliation

InstantGMP Inventory Use Screen Example:

32 Quick Discussion How does this differ from how your firm controls in-coming materials and inventory?

Master Production Record

Master Production Records (MPR) describe how manufacturing will be done An MPR copy creates a Batch Production Record which captures what is actually done when a batch is made Each MPR can be used to make multiple Batch Production Records MPRs are needed for: Work in Process Manufacturing Packaging Labeling Relevant SOPs:POL-0306 InstantGMP Production System StrategySOP-600 Master Production Record

InstantGMP MPR Manufacturing Instructions Example:

InstantGMP MPR Manufacturing Instructions Example:

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 Relevant SOPs:POL-0300 InstantGMP ManufacturingPOL-0306 InstantGMP Production System StrategySOP-601 Batch Production Record

InstantGMP BPR Instructions Screen Example:

42 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

44 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 Relevant SOPs: SOP-208 Deviations SOP-209 Complaints SOP-211 Product Recalls SOP-214 Material Disposition

Tracking of Inventory Distribution Example:

48 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!”

49 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?

50 Getting Ready for Technical Training Preparation: Downloading Join.me desktop App Presenting your screen in Join.me for Technical Training sessions 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)

51 Join.me Meeting - Remote Training When the trainer passes the presenter role, you will download the App:

52 Join.me Meeting - Remote Training When prompted, click Save File:

53 Join.me Meeting - Remote Training Click the Download arrow in the upper right corner of your Firefox window. Click the join.me.exe entry at the top of the list:

54 Join.me Meeting - Remote Training Click Run when prompted: Close window:

55 Join.me Meeting - Remote Training At this point, you have shown that you can share your screen so we can start the next Technical Training session

56 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”.

57 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”.

58 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).

59 Join.me Meeting - Remote Training Troubleshooting Others cannot see my screen, or sees something different from what I am presenting Primary fix: Use the sharing button in the middle of the join.me interface to select the proper screen if you have multiple displays. The downward pointing drop-down triangle has Share screen... option. If you click this, then click anywhere in the display you want to share, the problem should be resolved Alternate fix: Make sure Adobe Flash Player is installed from the following link: It can be install from here for free: User gets redirected to the join.me home page, with an error about Flash Player User will need to install Flash for free by going to Unable to see the customer's screen When you request to pass the presenter role for screen sharing, the user will be asked to download join.me. This process will vary by browser, but steps 5-8 will apply if using Firefox. Chrome and IE place the download notifications in a bar on the lower part of their screen. Once the user downloads join.me, they will be able to share their screen.

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

TITLE:NUMBER: EFFECTIVE DATE: Upon last signature PAGE 60 of 60 InstantGMP OrientationTRN VERSIONEFFECTIVE DATEDESCRIPTION OF CHANGE 00New 01 VERSION HISTORY APPROVALSTITLESIGNATURE/DATE Reviewed By: Richard Soltero President 5/4/15 Reviewed By: Patrick Staunton Trainer 5/4/2015 Approved By: Gretchen Rizor Quality Assurance 5/4/2015 APPROVAL BLOCK