Learning Objectives Upon completion of this training module, you will be able to: - PowerPoint Presentation

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Learning ObjectivesUpon completion of this training module, you will be able to:

Understand the FDA requirements for current Good Manufacturing Practices

Distinguish between “Good” and “Bad” Manufacturing PracticesUnderstand your role in applying the current Good Manufacturing PracticesIdentify the key activities that are required, when working in a regulated industryKnow how to better ensure that our products are made, built, shipped, stored and distributed properly – all with the goal of keeping the patient, customer and our own employees safe. Understand Haemonetics compliance to Data Integrity.

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Content:

Lesson 1: Regulatory Requirements

Lesson 2: Process ControlGood Process ControlProcess Qualification and Change ControlLabeling and Packaging Control

Storage, Handling and Distribution Control

Lesson 3: Production Control

Material and Component ControlTools and Equipment ControlFacilities and Environment ControlDocumentation and Record ControlIT Systems and Electronic Record ControlLesson 4: Reporting IssuesLesson 5: Data IntegritySummary

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It is good for our customers

Patients rely on our products – it is crucial that these products be safe and effective.

High quality products reduce the cost for our customers.It is good for our businessOur credibility and reputation depend on the quality of our products.We reduce the cost of repair/rework when our products are high quality to begin with.We operate in a regulated industryThere are multiple requirements across many different countries that we must comply with, in order to provide products to our customers in those countries.

Why is Quality so critical?

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Lesson 1

: Regulatory Requirements

These regulations require that the following be built into all drugs and medical devices: Safety: product is free from unknown side effects when used as directedIdentity: product is what the labeling describes it to beStrength (Potency): product delivers what its label claimsPurity: product is free from microbial, chemical and physical contaminationQuality: product meets regulatory requirements wherever sold, and can be made consistently, time after timeWhy?

These regulations make sure the customer is protected and is only receiving high quality product. If a product does not meet the above requirements, it is considered adulterated and is not fit for use.

cGMP – Current Good Manufacturing Practices

cGMP training is compliant with

ISO13485 standards as well as 21CFR 820 and Part 210/211

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Lesson 1

: Regulatory Requirements

What does this mean to you? In other words…Each person should be made aware of the importance of his or her individual contributions in the overall effort to achieve an acceptable level of quality. All personnel should be made aware that product quality is not solely the responsibility of management or any other single group. Quality is the responsibility of every employee.

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Content:

Lesson 1: Regulatory Requirements

Lesson 2: Process ControlGood Process ControlProcess Qualification and Change ControlLabeling and Packaging Control

Storage, Handling and Distribution Control

Lesson 3: Production Control

Material and Component ControlTools and Equipment ControlFacilities and Environment ControlDocumentation and Record ControlIT Systems and Electronic Record ControlLesson 4: Reporting IssuesLesson 5: Data IntegritySummary

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Lesson 2

: Process Control

Qualification and Change Control Labeling and Package Control Storage, Handling and Distribution ControlGOOD PROCESS CONTROL, controls HOW the product is built

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Lesson 2: Process Control

Good Process Control means having established systems that consistently produce a quality product, such as using documented procedures for product builds.

Some examples of this in Haemonetics are: Standard Operating Procedures (SOP)Work Instructions (WI or WINs) Manufacturing Instructions (MI)Standing Instructions (SI) What does this mean for you? Always make sure that you: Have

the correct written instructions before starting a task.

H

ave completed training on the instructions before performing those activities. Follow the instructions precisely. Follow instructions in MI, SI, and Device History Records (DHR or PHRs) in order. Lookout for mistakes, defects and unusual events.

Report

them to your supervisor

immediately

.

Make clear, accurate records of what was done and the checks that were carried out.

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Lesson 2: Process Control

There can be no change to a product, material, process, major equipment, test method, document or specification unless approved according to the appropriate procedure.

As a part of this change control process, it must be determined what re-training or additional training might be required, due to the significance of the change (whether it is major or minor). Process Qualification and Change ControlThese change control requirements are designed to make sure that the product being built after a change will continue to meet its specifications.

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Lesson 2: Process Control

Proper controls of labeling are important to prevent mix-ups and the use of unapproved labeling. These controls include labeling that is needed for receipt, identification, storage, handling, sampling, examination and/or testing.

Mislabeling of product can result in health hazards for our customers and the recalling of our products. Packaging and Labeling Control What does this mean for you? Always make sure that you: Look out for labeling errors and only use labels that are approved. Be sure to follow all labeling and line clearance procedures.Check that labels are stored in a sealed bag or the adhesive will get weaker over time. Check that the surface is clean where the label will be put.

Report issues to your supervisor, when you see that labels are coming detached or appear to be incorrect or in the wrong place.

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Lesson 2

: Process Control

The distribution of products must track each lot of product to the customer to ensure a system is able to recall the product if necessary. The distribution process should ship the oldest approved lots as a priority. (First In, First Out) The storage of products and component materials must follow a written process that defines how the quarantine process prevents the use of unapproved products and materials. Storage, Handling and Distribution ControlThe process must also state the conditions for storage to maintain appropriate:

Temperature

Humidity and

Light This is so that the identity, strength, quality, and purity of the products are not adversely affected.

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Content:

Lesson 1: Regulatory Requirements

Lesson 2: Process ControlGood Process ControlProcess Qualification and Change ControlLabeling and Packaging Control

Storage, Handling and Distribution Control

Lesson 3: Production Control

Material and Component ControlTools and Equipment ControlFacilities and Environment ControlDocumentation and Record ControlIT Systems and Electronic Record ControlLesson 4: Reporting IssuesLesson 5: Data IntegritySummary

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Lesson 3

: Production Control

Material and Component Control Tools and Equipment Control Facilities and Environment Control Documentation and Record Control IT Systems and Electronic Record ControlGOOD PRODUCTION CONTROL, controls what is USED to build the product

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These processes focus on:

Receiving and Incoming Material Inspection

Receipt to Shelf and Shelf to Point-of-UsePut-away processesStorage, Handling, Sampling, TestingApproval or rejection of materialsINCOMING ACCEPTANCE: Materials are quarantined and checked for the correct part number and no damage to the packaging at receipt. They are then segregated based on those that can: Proceed directly to Inventory Need a CoC (Certificate of Conformance)Full Incoming Material InspectionLesson 3: Production ControlMaterials

that do not meet

specifications must be

rejected by Quality, quarantined and cannot be used to produce a finished product. The status (Quarantined/ Accepted/ NCR’d) of each lot must always be identified. Material and Component Control

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Lesson 3: Production Control

Rejected material on the shop floor must be easily identifiable or marked or labeled as non-conforming. This includes making sure parts or lots are listed with non-conforming numbers and are stored in a well-identified Non-Conforming Material Area.

Material and Component Control

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Lesson 3

: Production Control

Equipment and facilities must be designed, validated, controlled, calibrated, inspected, and maintained according to written procedures. Records of these activities must be maintained. Properly designed, installed, maintained, and cleaned equipment and facilities will help make sure that products meet their intended specifications. Tool and Equipment Control What does this mean for you? Always make sure that you: Check that each tool or piece of equipment is identified with a unique code. Check that each piece of equipment is stored properly. Make sure you have completed training on how to use equipment, before using it.

Check all date-coded materials

prior

to use to make sure the materials are still acceptable for use. Check that if a tool or piece of equipment appears damaged or inoperable in any way, you report it to your supervisor immediately.

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Lesson 3: Production Control

Tool and Equipment Control

All manufacturing equipment must be properly cleaned and sanitized. This helps prevent contamination to our products.

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Lesson 3

: Production Control

Calibration is the comparison of two instructions or measuring devices – one of which is the standard of known accuracy. By comparing these tools, we make sure that the tools used to measure, test or inspect product, are consistently accurate. This is important, because it makes sure that the parts and products we build are consistently accurate. Calibration What does this mean for you? Always make sure that you: Check all tools and equipment for calibration dates prior to use. Check that for any tools used for measurement and that determine if a part “passes” or “

fails”, make sure it is calibrated.

Check that if a tool or piece of equipment appears damaged or inoperable in any way, you report it to your supervisor immediately.

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Lesson 3

: Production Control

The term Electro-Static Discharge (ESD) refers to a charged person or object, discharging static electricity. Current associated with such a static charge is low, but the electric potential can be in the millions of volts and can severely damage electronic components. This is a safety measure for our employees as well as our customers. These labels can be affixed to the floor, a work station or indicate an entire area.

When these signs are present, ESD practices are a MUST!

Facilities and Environment Control

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Lesson 3

: Production Control

Check the heel strap and wrist strapTest your shoes once every 4 hoursElectro-Static Discharge EtiquetteGround strap monitoring

Electro-static dissipative

lotion

Electro-static dissipative footwear

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Haemonetics policies are designed with your safety in mind.

ALWAYS follow procedures, safety rules and posted signs.

Lesson 3: Production ControlFacilities and Environment Control

Buildings and facilities are also designed to ensure a clean, maintained environment for our operations and our employees.

Be sure to report any facility issues or areas that require maintenance.

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Lesson 3: Production Control

Facilities and Environment Control

Contamination control prevents an undesirable substance from entering a product. Contamination control can also include proper procedures for pest control, air handling systems, sampling methods and facility access and maintenance. Contamination can come from many different sources: Clothing fibersLintMake-up HairFalse eyelashes

Dirt & dust

Water

Food

Smoking

Paper & pencils

Inadequate cleaning

Cuts, burns or sores

New tattoos/body piercings

Poor personal hygiene

Coughing & Sneezing

Infections and illness

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Lesson 3: Production Control

Facilities and Environment Control

A lack of personal hygiene and cleanliness can lead to contamination from many sources. Employees must take care to limit or eliminate introducing these into all manufacturing areas. All of these items can be sources of contamination and must be kept out of the cleanrooms:

NO MAKEUP, LIPSTICK, ARTIFICIAL NAILS

, ARTIFICIAL EYELASHES,

OR NAIL POLISH

WATCHES, JEWELRY AND EARRINGS ARE PROHIBITED

NO HATS, LARGE COATS OR JACKETS

LEGS MUST BE COVERED AT ALL TIMES

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Lesson 3

: Production Control

Facilities and Environment Control

What does NOT belong in a cleanroom?

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Lesson 3: Production Control

Facilities and Environment Control

Proper gowning and cleanroom procedures make sure that we prevent as much contamination from reaching the product as possible. Employees that work in these areas, must comply with the following: Always follow your local procedures for gowning-up and gowning-down properly.

Wash your hands thoroughly – this may be with either water or alcohol gel, depending on your site.

When putting on shoe booties,

but be sure to keep

feet

with booties

touching only the

“clean”

side.

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Lesson 3

: Production Control

Facilities and Environment Control What does this mean for you? Always make sure that you: Wear the appropriate gear per your local procedures. This may include head-coverings, beard-coverings, earplugs, shoe booties, smocks or jumpsuits or lab coats, safety goggles, gloves, etc. Gown-up and gown-down the correct way, in the correct order. Gown-up: Head to toeGown-down: Toe to head

Dispose of any hair coverings or ear-plugs. Do not re-use these items.

Always be sure to follow the correct procedures, for the area you will be working in.

For restricted areas, only authorized personnel are allowed. Follow all work-signs in your area (ESD, Authorized Personnel, Gowning/Cleanroom, Disposal signs). Your supervisor will provide training on special requirements for your work area.

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Lesson 3: Production Control

Facilities and Environment Control

Employee sanitation habits are key to preventing contamination: Daily bathingClean clothes and work shoesClean and trimmed fingernailsWash your hands frequentlyEmployee health is also key to making sure no contaminants reach our products and our customers. Please contact your supervisor if you have any of the following:

Do NOT enter the cleanroom if you

have

or could have any of the following: Pink eye

Ringworm

Lice

Severe colds

Excessive coughing

Excessive runny nose

Open sores or lesions on your hands

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Good documentation helps to make sure the production and distribution of a product that will meet the safety, identity, strength, quality and purity standards.

All procedures must be:

DocumentedApprovedCurrent AvailableLesson 3: Production ControlDocumentation and Record ControlSome records required by the GMP regulations: Calibration Records

Validation Records

Device History Records (DHRs or PHRs)

Training RecordsNon-conforming material recordsChange RecordsStandard Operating Procedures (SOPs)Work Instructions (WI or WINS)Manufacturing Instructions (MI)Standing

Instructions (SI

)

Bill of Materials (BOM)

Specification Sheets (Specs)

Complaints

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Using Good Documentation Practices helps ensure the identity, authenticity and accuracy of documents. It explains:

WHAT you did

WHEN you did it and HOW you did it. Lesson 3: Production ControlGood Documentation Practices What does this mean for you? Always make sure that you:

Use permanent ink

Completely and accurately fill in documents and forms, immediately after the task is completed

Submit documents and forms in a timely manner. Quality records must be retained and stored properly. Make corrections by: Putting a single line through the errorRecord the correct value or informationAdd your initials and date near the correctionDo NOT use white-out or erase information

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Lesson 3: Production Control

Documentation and Record Control

Never use ‘white-out’ or correction tape

The Right Way

The Wrong Way

The Right Way

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Lesson 3: Production Control

Data and Document Falsification

The intentional actions can include: Recording incorrect or altered data Back-dating or future-dating entries Failure to record information Failure to record information at the time it happened Recording information without signing and dating the document Copying information without indicating the information was copied Destroying/Throwing out original data Signing another individual’s name Note: Because falsification of data or documents can lead to products that are adulterated or misbranded being shipped or used by our customers, falsification of data or documents is against the law.

Having adulterated medical products available to our customers and patients is illegal and punishable by the law

.

Falsification of data involves purposeful, deliberate, or intentional actions.

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Lesson 3

: Production Control

The electronic systems must be: ValidatedControlledSecuredRecords created and maintained by the system must be retained and stored per record retention procedures. A user of the electronic system should realize that data entered might require an electronic signature. If so, this electronic signature has the same significance and is as legally binding as their handwritten signature. Electronic, IT, Data System Control

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Content:

Lesson 1: Regulatory Requirements

Lesson 2: Process ControlGood Process ControlProcess Qualification and Change ControlLabeling and Packaging Control

Storage, Handling and Distribution Control

Lesson 3: Production Control

Material and Component ControlTools and Equipment ControlFacilities and Environment ControlDocumentation and Record ControlIT Systems and Electronic Record ControlLesson 4: Reporting IssuesLesson 5: Data IntegritySummary

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Lesson 4: Reporting issues

What do I do if I find a non-conforming event?

Definition: A non-conforming event, is an event that is not in conformance with the established requirements or specifications. It can be either process or product focused.Action: Log a Non-Conforming Event (NCE) in Agile. Haemo NCE Owner access will need to be requested/granted, before this can begin. If you don’t have the appropriate access, you can:

Contact your supervisor or a quality representative.

Request access via HaemoITHelp

Note: NCEs are assessed for whether a CAPA (Corrective Action/Preventive Action) may be required. This assessment is documented in the NCE record.

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Key questions to answer, when documenting a Non-Conforming Event (NCE):

Lesson 4

: Reporting issues

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Complaints

Within Haemonetics, a product complaint is defined as:

“Any written, electronic or oral communication alleging deficiencies relating to the identity, quality, durability, reliability, effectiveness, safety, security or performance of a released Haemonetics product or an expression of dissatisfaction with a Haemonetics product.” Note:

Services are also considered products and can be subject to a complaint. ISO-13485 states that wherever the term “product” occurs, it could also mean “service

”. Service records are reviewed for potential complaints.

http://haemonetics.com/en/Support.aspx To log a complaint or potential complaint:

Contact your supervisor

OR

Connect to the Haemonetics.com website

 then click on Customer Support

Lesson 4

: Reporting issues

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GMP Summary

Using current Good Manufacturing Practices is everyone’s responsibility:

What does this mean for you? Make sure you’re using the latest revision of a procedure or document Make sure you are trained to the latest revision of a procedure or document, before performing that activity/task Keep your workplace clean and tidyAlways check the quality of your work before you hand it overAlways follow the proper gowning and de-gowning proceduresAlways follow good sanitation and employee health habits to prevent contaminationAlways obey the signs for limited or restricted access areasAlways report an issue or problemIf you don’t know what to do, ask your supervisor

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Content:

Lesson 1: Regulatory Requirements

Lesson 2: Process ControlGood Process ControlProcess Qualification and Change ControlLabeling and Packaging Control

Storage, Handling and Distribution Control

Lesson 3: Production Control

Material and Component ControlTools and Equipment ControlFacilities and Environment ControlDocumentation and Record ControlIT Systems and Electronic Record ControlLesson 4: Reporting IssuesLesson 5: Data Integrity

Summary

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Data Integrity

All data must be recorded on durable media

Data

Integrity

The degree to which a collection of data are complete, consistent and accurate throughout the data lifecycle.

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FDA Requirements for Data Integrity

Data Integrity and Compliance With Drug CGMP Guidance for Industry (Dec 2018)

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Data Integrity Effort & RemediationEfforts are focused on

Prevention of Data Integrity Issues!!

Senior Management Support required to ensure policies are in place to educate and/or deal with potential DI issuesEstablish and maintain GDP and Data Integrity policies. Train affected personnel on these policiesSystem design with lifecycle approach Validate the system intended useEstablish and implement the appropriate controls to prevent and detect potential issuesUse the Quality Risk Management approach for managing changesData management integration into the Quality SystemContinuous improvement and Culture of “Notify Immediately”Data integrity assessments into the audit programQuality audits to enforce policies

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Data GovernanceThe sum of arrangements to ensure that data are recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle.

This is irrespective of the format in which is generated.

Elements of Data Governance

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Data Integrity Requirements for Computerized SystemsRequirements for Electronic Records and Electronic Signatures (ERES)

Record retention requirements do not differ from paper applications that require ER and are applicable to:

Automated Manufacturing EquipmentLab EquipmentProcess Controls (PLC)Data Analysis (Minitab)Planning and Manufacturing execution system (ORACLE)Lab Information Management Systems (LIMS)Contact Management Systems (CMS)Spreadsheets (Excel)

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ALCOA

A

ttributable: Identify the individual who performed the recorded task.Legible: Information must de readableContemporaneous: Actions, events or decisions shall be recorded on paper or electronically.Original: First-capture of information, whether recorded on paper or electronically.A

ccurate

: Results and records shall be accurate (generated by validated systems or certified personnel).

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Applicability of ALCOA

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Applicability of ALCOA (cont.)

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Applicability of ALCOA (cont.)

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FINISH:You have successfully completed the course – current Good Manufacturing Practices (cGMP)

Before you receive credit for this course, you must complete and pass the quiz.