gtps vs. cgmps

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WR Tolbert & AssociatesConsultants to the

Biopharmaceutical Industry

11483 Cypress Woods DriveSan Diego, CA 92131-3535

858-693-8163

[email protected] / www.wrtolbert.com

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Dogs Bark, Cows Moo, Regulators Regulate...

Frank Young, M.D.former FDA Commissioner

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FDA History 1820 U.S. PHARMACOPEIA 1848 DRUG IMPORTATION ACT 1902 BIOLOGICS CONTROL ACT

1901 – 13 Children Died of Tetanus due to Contaminated Diphtheria Antitoxin

1906 FOOD AND DRUGS ACT 1938 THE FEDERAL FOOD, DRUG, AND

COSMETIC (FDC) ACT 1944 PUBLIC HEALTH SERVICE ACT 1976 MEDICAL DEVICE AMENDMENTS

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FDA’s Purpose To ensure the

Safety Efficacy Quality (Identity, Strength/Potency, Purity)

of Drug, Biologic and Device Products by control of manufacturing, advertising and distribution though various licensing and approval requirements.

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FDA “Centers” CDER – Center for Drug Evaluation and

Research (Small Molecule Drugs and Specified Biotechnology Products).

CBER – Center for Biologic Evaluation and Research (Vaccines, Blood, Non-Specified Biotechnology Products).

CDRH – Center for Devices and Radiological Health (Medical Devices).

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FDA Inspections ORA – Office of Regulatory Affairs

(Regional and District Offices) All inspections except for CBER pre-

approval (PAI) for biologic products.

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Foreign Regulatory Agencies Health Canada -Health Products and

Food Branch [www.hc-sc.gc.ca/hpfb-dgpsa/

index_e.html] EMEA (EU Regulatory Body)

[www.emea.eu.int]

Japan Ministry of Health, Labour and Welfare [www.mhlw.go.jp/english]

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Information Sources

FDA Home Page [www.fda.gov] CDER Home Page [www.fda.gov/cder] CBER Home Page [www.fda.gov/cber] CDRH Home Page [www.fda.gov/cdrh] ORA Home Page [www.fda.gov/ora] FDA Search Page

[www.fda.gov/search.html]

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Information Sources

Federal Register: 1994 – 2005 [www.gpoaccess.gov/fr/index.html]

The Code of Federal Regulations [www.gpoaccess.gov/cfr/index.html]

CLIA Home Page [www.fda.gov/cdrh/clia]

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The Primary Requirement / Roadblock

FDA Market Approval NDA, ANDA - CDER BLA - CBER PMA, 510K - CDRH

Obtained by data on Safety and Efficacy collected during clinical trials. (IND/IDE)

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FDA Tools Laws

The Federal Food Drug and Cosmetic (FDC) Act (1938)

The Public Health Service Act (1944 – Biologics) Medical Device Amendments (1976)

Regulations – Title 21 Code of Federal Regulation (21 CFR) – May be enforced in court.

Guidelines – Provide FDA’s current regulatory positions/thinking on various topics.

ICH Guidelines – Internationally accepted.

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Cross Regulation Themes and Concerns

Documentation. Personnel qualification and training. Independent oversight by the Quality

Unit (Quality Assurance and/or Quality Control Unit).

Data integrity. Personal Responsibility.

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The Existing Regulatory Environment

21 CFR PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES [Computer Use]

21 CFR PART 58—GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES [GLPs]

21 CFR PARTs 210-211—CURRENT GOOD MANUFACTURING PRACTICE [cGMPs]

21 CFR PARTs 600-680—BIOLOGICAL PRODUCTS 21 CFR PART 820—QUALITY SYSTEM REGULATION

[Medical Device GMPs] 42 CFR 493—LABORATORY REQUIREMENTS

[Clinical Laboratory Improvement Amendments of 1988 – CLIA]

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How are Cell-Based Products Different?

Potential for adventitious agents in starting material - possible lack of adequate methods for testing or removal.

Requirement for “aseptic processing”

Inability to effectively “sterilize” the product and often implantation must occur before testing is complete.

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FDA Driving Forces & Challenges for Cell Products

Previous approach (pre 1997) fragmented inadequate inadequate

New products (e.g. stem cells, tissue-engineered, etc.)

New manufacturing technologies, degree of manipulation

Increasing public health concern Increasing demand for cells and tissues Public confidence in products - expectation for

expectation for safe & effective product Industry standards not always followed, not

enforceable

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Cell and Tissue Characteristics

Autologous vs. Allogeneic Viable vs. Nonviable Banked vs. Unbanked Homologous vs. Non-homologous function Minimal vs. More than minimal

manipulation Structural vs. Systemic function Combination product– device, biologic or

drug

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FDA Regulation of Cellularand Tissue-based Products

Human cells, tissues, or cellular or tissue-based products based products [HCT/P’s] Articles containing human cells or tissues that

are intended for transplantation, infusion or transfer into a human recipient

Not including vascularized organs, allogeneic bone marrow transplantation, transfusable blood/blood components, xenotransplantation

Provides a unified, comprehensive regulatory framework

Provides a tiered regulatory approach level of regulation proportional to the degree of

risk

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New FDA Regulation 21 CFR 1271: PART 1271— HUMAN CELLS,

TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Subpart A—General Provisions Subpart B—Procedures for Registration and Listing Subpart C—Donor Suitability Subpart D—Current Good Tissue Practice (cGTPs) Subpart E—Additional Requirements for

Establishments Described in § 1271.10 (PHS 361 Products)

Subpart F—Inspection and Enforcement of Establishments Described in § 1271.10 (PHS 361 Products)

Final Rule is effective May 25, 2005.

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21 CFR Part 1271“A Line in the Sand”

Regulated As

HCT/P’s under Section 351 of PHS Act

(Biologics or Devices -Must prove safety and

efficacy)

HCT/P’s under Section 361 of PHS Act

(Only for prevention of communicable disease –

No proof of efficacy)

· More than minimally manipulated

· Intended for Non-Homologous Use

· Systemic effect dependent upon metabolic activity (Allogeneic, except close relative)

· Clinical effect is systemic or dependent upon the metabolic activity of the cells for its primary function

· Combined with a device, drug or biologic

· Generally, HCT/P’s recovered, processed, stored, or distributed by methods not intended to change tissue function or characteristics

· Minimally manipulated, homologous use, metabolic tissue for self or close blood relative, or for reproductive use

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Regulatory Requirements for HCT/P’s

“A Line in the Sand”

cGMPs Biologics cGTPs

cGTPs cGTPs cGTPs

QSRs Biologics cGTPs

Tissue CellularTherapeutic

TissueEngineering(Combination of Cells and Device)

Requirements

Premarket Approval

351 PHS Act , FD&CIND, IDE, BLA, PMA

Marketing NotificationFD&C 361 PHS Act

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21 CFR Part 1271Establishment Registration and Listing

Requires establishments to register with FDA and list HCT/P’s Exclusions for some (e.g., storage,

carriers, contractors engaging only in recovery and transport)

Lists criteria to determine if HCT/P’s regulated solely under 361 PHS Act

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21 CFR Part 1271Donor Eligibility

Screening and testing of most cell and tissue donors for relevant communicable diseases Exception for autologous donor/ sexually intimate

partner Donor must be eligible prior to HCT/P

administration Free of risk factors & clinical evidence of

communicable disease Acceptable test results Limited exception to use when eligibility

determination not completed urgent medical need, w/o other comparable HCTP

available Limited use of HCT/P from an ineligible donor

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21 CFR Part 1271Good Tissue Practices

Procedures and controls to prevent introduction, transmission and spread of communicable disease by HCT/P’s communicable disease agents – prior to and

during manufacturing Organized around core requirements, with

supporting requirements Follow all GTP requirements applicable to

function performed Requirement for a Quality Program

Flexibility to determine how to meet requirements

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21 CFR Part 1271

Inspection and Enforcement Applicability

Above the line (351 HCT/Ps) – Same as for other Biologics and Devices (Clinical, Pre Approval, Post Approval)

Below the line (361 HCT/Ps) – New requirements specified (Any time after registration)

Inspections May include your establishment, facilities, equipment, finished

and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and controls required to be maintained under Part 1271.

May question the personnel of the establishment as necessary to determine compliance

May take samples, may review and copy any records required to be kept under this part, and may use other appropriate means to record evidence of objectionable observations

The inspection may be made with or without prior notification The frequency of inspection will be at the agency’s discretion

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21 CFR Part 1271 Inspection and Enforcement

HCT/Ps offered for import Importer must notify, either before or at the time of

importation, the appropriate district director of the FDA (ORA)

Must provide sufficient information for FDA to make an admissibility decision

Does not apply to peripheral blood stem/progenitor cells regulated solely under PHS section 361, unless unreasonable risk of communicable disease

Enforcement Actions Include orders of retention, recall, destruction, and

cessation of manufacturing

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Compliance to cGMPs, QSRs, and Biologics Regulations vs. cGTPs

“The current good manufacturing practice regulations in parts 210 and 211 of this chapter and the quality system regulations in part 820 of this chapter supplement, and do not supersede, each other unless the regulations explicitly provide otherwise. In the event that a regulation in part 1271 of this chapter is in conflict with a requirement in parts 210, 211, or 820 of this chapter, the regulations more specifically applicable to the product in question will supersede the more general.” (For PHS 351 Products)

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Comparison cGMPs vs. cGTPs

No corresponding procedure

Personnel Appropriate education,

training, and experience

Specific training requirements

Specific responsibilities Adequate number of

personnel and supervisors

Exemptions and alternatives Procedure to request

changes in cGTPs for specific products

Personnel Appropriate

education, training, and experience

Train all personnel to perform their assigned responsibilities adequately.

Sufficient personnel to ensure compliance

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Responsibilities of quality control unit Must be independent Authority to review production

records and to assure that errors have been fully investigated

Responsibility and authority to approve or reject all components, in-process materials, drugs and drug products

Responsibility and authority or reject all procedures and specifications

The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

Adequate testing facilities shall be available

Establishment and maintenance of a quality program Preventing the introduction,

transmission, or spread of communicable diseases through the manufacture and use of HCT/Ps.

Ensuring that procedures exist for receiving, investigating, evaluating, and documenting information relating to core cGTP requirements

Providing audits and ensuring appropriate corrective actions relating to core cGTP requirements

Investigating and documenting HCT/P deviations relating to core CGTP requirements

Validate the performance of computer software

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Buildings and Facilities Buildings shall be of suitable

size, construction and location to facilitate cleaning, maintenance and proper operations.

Buildings shall have adequate space for equipment and materials and for process flows to prevent mix-up and contamination

Specific defined areas for operations to prevent mix-up and contamination

Other general and specific requirements for HVAC, plumbing, lighting, sanitation and maintenance

Specific aseptic processing requirements, as needed (2004 Aseptic Guidelines)

Requirements for written procedures and documentation.

Facilities Must be of suitable size,

construction, and location to prevent contamination and to ensure orderly handling of HCT/Ps without mix-ups.

Must maintain the facility in a good state of repair with suitable lighting, ventilation, plumbing, drainage, and sanitation to prevent the introduction, transmission, or spread of disease

Must divide a facility used in the manufacture of HCT/Ps into separate or defined areas of adequate size for each operation

Specific environmental control and monitoring requirements

Must document, and maintain records of, all cleaning and sanitation activities

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Equipment Equipment shall be of

appropriate design, adequate size and suitably located for its intended use

Product contact surfaces shall not be reactive, additive, or absorptive

Equipment shall be cleaned, maintained, and sanitized

Written procedures shall be established

Automatic equipment, including computers or related systems shall be routinely calibrated and inspected and input to and output shall be checked for accuracy

Appropriate controls shall be exercised to assure that only authorized changes

Records shall be kept of maintenance, cleaning, sanitizing, and inspection

Equipment Equipment must be of

appropriate design for its use and must be suitably located and installed to facilitate operations, including cleaning and maintenance. Any automated, mechanical, electronic, or other equipment used for inspection, measuring, or testing must be capable of producing valid results

Where appropriate, you must routinely calibrate all automated, mechanical, electronic, or other equipment used for inspection, measuring, and testing in accordance with this part

You must document and maintain records of all equipment maintenance, cleaning, sanitizing, calibration, and other activities performed

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Control of components and Containers and Closures Written procedures are required

for receipt, quarantine storage, status labeling and release

Specific procedures are require for sampling, testing and release or rejection and first in/first out shall be used to rotate released components

Rejected components shall be identified and controlled under a quarantine procedure

Containers and closures shall be clean and where appropriate, sterile and pyrogen free and shall not be reactive, additive, or absorptive

Standards/specifications and methods for testing, cleaning, sterilization, and depyrogenation shall be written

Supplies and reagents Must not use supplies and

reagents until they have been verified to meet specifications. Verification may be accomplished by the using establishment, or by the vendor of the supply or reagent

Reagents used in processing and preservation of HCT/Ps must be sterile, where appropriate.

Must validate and/or verify the processes used for production of in-house reagents

Must maintain records of the receipt, including the type, quantity, manufacturer, lot number, date of receipt, and expiration date; records of the verification; certificate of analysis and records of the lot of supply or reagent used in the manufacture of each HCT/P.

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Production and Process Controls Written procedures are

required for production and process control, change control and deviations must be recorded and justified

Adequate supervision and second person required to verify all critical steps

Equipment shall be uniquely identified and identification number recorded in the batch production record

Appropriate sampling and testing of in-process materials is required and valid in-process specifications shall be consistent with drug product final specifications and where possible determined by suitable statistical procedures

Processing and Process Controls Must recover and process each

HCT/P in a way that does not cause contamination or cross-contamination

Human cells or tissue from two or more donors must not be pooled during manufacturing

Must ensure that specified requirements for in-process controls are met, and that each in-process HCT/P is controlled until the required inspection and tests or other verification activities have been completed, or necessary approvals are received and documented. Sampling of in-process HCT/Ps must be representative of the material to be evaluated.

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Production and Process Controls Control procedures shall be

established to monitor and validate the performance of the manufacturing process to ensure uniformity

When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product

Procedures for non-sterile drug products shall be designed to prevent contamination. Procedures for sterile products and sterilization systems shall be validated

Written procedures shall be established for reprocessing batches. Reprocessing shall have quality control unit approval

Processing and Process Controls Any change to a process must

be verified or validated to ensure that the change does not create an adverse impact elsewhere in the operation, and must be approved before implementation by a responsible person

Where the results of processing cannot be fully verified by subsequent inspection and tests, you must validate and approve the process according to established procedures. Changes to a validated process must be reviewed and revalidation performed where appropriate

A published validated process must be verified in your establishment

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Packaging and Labeling Control There shall be written procedures

describing in sufficient detail the receipt, identification, storage, handling, sampling, examination and/or testing of labeling and packaging materials, including label specifications; quarantine and release; destruction of rejected or obsolete labels and reconciliation of label quantities issued, used, and returned

Holding and Distribution Written procedures are required

for holding, quarantine, and storage of a drug product

Written procedures are required for distribution of drug products and the distribution system shall facilitate recall, if necessary

Labeling controls Must establish and maintain

procedures to control the labeling of HCT/Ps and must design these procedures to ensure proper HCT/P identification and to prevent mix-ups.

Must include verification of label accuracy, legibility, and integrity.

Storage Must control storage areas and

stock rooms to prevent mix-ups, contamination, and cross-contamination of HCT/Ps, supplies, and reagents

Must establish acceptable storage conditions of HCT/Ps at each step of the manufacturing process to inhibit the growth of infectious agents and must document storage conditions.

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Laboratory Controls Specifications, standards,

sampling plans and other laboratory controls shall be reviewed and approved by the quality control unit

Out-of-specification results shall be appropriately investigated. OOS events shall be tracked (Bar Decision-not specifically listed in regulation)

All laboratory operations shall be documented at the time of performance

Calibration of instruments, apparatus, gauges, and recording devices at suitable intervals in accordance with an established written program

No Corresponding Laboratory Requirements

Receipt, predistribution Must evaluate each incoming

HCT/P for the presence and significance of microorganisms and inspect for damage and contamination.

Must determine whether to accept, reject, or place in quarantine each incoming HCT/P, based upon pre-established criteria designed to prevent communicable disease transmission

Shipments prior to distribution must ensure prevention of disease transmission

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Laboratory Controls The accuracy, sensitivity,

specificity, and reproducibility of test methods employed by the firm shall be established and documented (Methods Validation)

Release testing is required prior to drug product distribution and products failing to meet specifications and any other relevant quality control criteria shall be rejected

There are specific requirements for stability testing and establishment of expiration dates

Appropriately identified reserve sample(s) representative of each product lot and active ingredient shall be retained

Distribution of an HCT/P Prior to distribution must review

HCT/P manufacturing and tracking records and must verify and document that the release criteria have been met. A responsible person must document and date the determination that an HCT/P is available for distribution

Must not make available for distribution an HCT/P that is in quarantine, is contaminated, or is recovered from a donor who has been determined to be ineligible

Packaging and shipping containers must be designed and constructed to protect the HCT/P from contamination

You must establish and maintain procedures, including release criteria, for the these activities

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Records and Reports There are specific requirements

for record retention and storage, either as originals or as true copies by an accepted method

All documents and records shall be readily available for inspection

Records must be maintained to facilitate annual review of data for evaluation of product specifications and production procedures. Written procedures shall be established and followed for such evaluations

Responsible officials of the firm shall be notified in writing of any investigations, recalls, reports of inspectional observations issued by the FDA, or any regulatory actions relating to cGMPs

Procedures Must establish and maintain

procedures appropriate to meet core cGTP requirements for all steps that you perform in the manufacture of HCT/Ps and must design these procedures to prevent increased risk of the introduction, transmission, or spread of communicable diseases. Before implementation, a responsible person must review and approve these procedures.

If adopt current standard procedures from another organization, must verify that the procedures meet the cGTP requirements and are appropriate for your operations.

These procedures must be readily available to the operating personnel

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Records and Reports Equipment cleaning and use

log Component, drug product

container, closure and labeling records

Master and Batch Production and Control Records (MPR and BPR)

Distribution records All records must be reviewed

and approved by the quality control unit

Thorough investigation is required for any failure or discrepancy, including other related product batches

A written record shall be made of the investigation and shall include the conclusions and follow-up

Records Must maintain records

concurrently with the performance of each step required by the cGTPs

All records must be accurate, indelible, and legible and must identify the person performing the work and the dates of the various entries, and must be as detailed as necessary to provide a complete history of the work performed

Must establish and maintain a records management system relating to core cGTP requirements. Under this system, records pertaining to a particular HCT/P must be maintained in such a way as to facilitate review of the HCT/Ps history before making it available for distribution

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Laboratory Records Shall include complete data

derived from all tests necessary to assure compliance with established specifications and standards

A description of the sample received for testing with identification of source, quantity, lot number, date sample was taken, and date sample received

A statement of each method used in the testing of the sample and a complete record of all data secured in the course of each test

A record of all calculations performed in connection with the test and a statement of the results of tests and how the results compare with established standards/specifications

Records May maintain required records

electronically, as original paper records, or as true copies. Electronic records must be backed up

Must retain all records for 10 years after their creation, unless stated otherwise and retain the records pertaining to a particular HCT/P at least 10 years after the date of its administration

Tracking Must establish and maintain a

system that enables the tracking of all HCT/Ps from donor to the consignee or final disposition and from consignee or final disposition to the donor.

Must ensure that each HCT/P is assigned and labeled with a distinct identification code

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Records and Reports The signature of the person who

performs each test and the date(s) the tests were performed and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards

Complete records shall be maintained for

Any modification of an established method

Any testing and standardization of reference standards, reagents, and standard solutions

Periodic calibration of laboratory instruments, apparatus, gauges, and recording devices

All stability testing performed

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Complaint File Written procedures describing

the handling of all written and oral complaints regarding a drug product shall be established and followed

Procedures shall include provisions for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications

Procedures shall include provisions for review to determine whether the complaint represents a serious and unexpected adverse drug experience which is required to be reported to the FDA

A written record of each complaint shall be maintained in the file

Complaint File Must establish and maintain

procedures for the review, evaluation, and documentation of complaints relating to core current good tissue practice (cGTP) requirements, and the investigation of complaints as appropriate

Must maintain a record of complaints that you receive in a file designated for complaints that is available for review and copying upon request from FDA

Must determine if the complaint is related to an HCT/P deviation or to a adverse reaction, and whether an Adverse Reaction Report to the FDA is required

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Complaint File Specific retention times for the

complaint files are listed The written record shall

include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant

Where an investigation is conducted, the written record shall include the findings of the investigation and followup

Where an investigation is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination

Complaint File As soon as practical, you must

review, evaluate, and investigate each complaint that represents an event required to be reported to FDA or a complaint relating to core cGTP requirements

When no investigation is made, you must maintain a record that includes the reason no investigation was made, and the name of the individual(s) responsible for the decision not to investigate.

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Returned drug products Returned drug products shall be

identified as such and held until appropriate disposition

If the conditions under which returned drug products have been held, stored, or shipped casts doubt on drug quality attributes, it shall be destroyed

A drug product may be reprocessed provided the subsequent drug product meets appropriate standards, specifications, and characteristic

Records of returned drug products shall be maintained

Drug product salvaging Drug products that have been

subjected to improper storage conditions shall not be salvaged and returned to the marketplace

Return to inventory You must establish and

maintain procedures to determine if an HCT/P that is returned to your establishment is suitable to be returned to inventory

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FDA Inspections Except for pre-approval inspections associated with

PMA (Devices), BLA (Biologics) or NDA/ANDA (Drugs) applications, FDA inspectors will arrive unannounced.

FDA inspectors are the equivalent of law enforcement officers and if refused admittance will return with a Federal Marshal

Drug and biologic manufacturing facilities producing approved products will be inspected on a two year cycle

Any facility may be inspected for cause at any time Testing facilities are most likely to be inspected as

an extension of an FDA inspection of a client organization

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cGMP Sanctions The ultimate sanction for a cGMP violation

is jail for executives and responsible individuals

Lesser sanctions include fines, closing of the facility, warning letters, consent decrees, disqualification of testing results, etc.

All negative findings including 483’s are available to anyone through the Freedom of Information Act

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Additional Valuable cGMP Information

Compliance Program Guidance Manual for FDA Staff – Inspections [www.fda.gov/cder/dmpq/compliance_guide.htm]

FDA/ORA Compliance Policy Guides Manual [www.fda.gov/ora/compliance_ref/cpg]

ICH Guideline Q7A - Good Manufacturing Practices for Active Pharmaceutical Ingredients [www.fda.gov/cder/guidance/4286fnl.htm]

Aseptic Processing Guideline [www.fda.gov/cder/guidance/5882fnl.htm]

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Open vs. Closed Manufacturing Systems

FDA Cleared or Approved Sterile Tube Connecting Device (STCD) – Tubing Welders Developed for the Blood industry.

STCDs may be used for interconnecting sterile bag systems for cell and gene therapy applications.

6ftBiosafety

Process Room20.5' x 12.0'

PassThru

Roller

Incubator

Centri-fuge

Media

Tank

Waste

Tank

Cart

MicroFluidizerBioreactor

Sys HarvestTank

HarvestTank

Cart

Pass

Th

ru

Car

tP

ass

Th

ru

SS TableMicroscope

Example of Required Facility Flows

PersonnelFlow

BiologicalComponent Flow

Material andSupply Flows

Sterile EquipFlow

Was

te F

low

Con

tam

inat

ed E

quip

Flo

w

In-ProcessProduct Flow

PersonnelFlow

Class 10,000

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Material and Supply Flow

Locked

Quarantine

Cage

LN2 Tanks T418B

TechnicianCubicals

T417

TechnicianCubicals

T415

QC AnalyticalLaboratory

T430

Equipment CleaningT414

Equipment PreparationReady Supplies T416

ReleasedMaterials

T420Cell BankT431

QCMicrobiologyLaboratory 1

T433

QCMicrobiologyLaboratory 2

T435

Acc

ess

Cor

rido

r AT

410

Clean Staging T450

PlasmidBuffer Prep

T470

Level 1 Degown

T412

Exit Staging T460

Plasmid PassThru T471

PlasmidLevel 1GownT472

PlasmidProduction 2

T475

PlasmidProduction 1

T474

Access C

orridor BT

418

Level 1 GownT445

Level 3Gown/Degown

T454 ProductFreezing

QuarantineT447

LabelInspect T448

ProductFillingT455Gene Therapy 1

T453Gene Therapy 2

T463

Cell Therapy 1T452

Cell Therapy 2T462

Clinical Production Corridor T400A

CoatsDepackaging

T405

DocumentationT407

QA ManagerT409

Production DirectorT411

QC ManagerT413

Level 2Degown

T461

Level 2GownT451

PassThru

PassThru

K

L

L

K

PlasmidLevel 1Degown

T473

Cart

Pass

Thru

L

K

CartPassThru

CartPassThru

Bul

k P

rodu

ctS

tora

ge

K

CartPassThru

CartPassThru

Autoclave MechRm T414A

CleanClosetT441

CartPassThru

CartPassThru K

Gas Cylinders T418A

Cart

Pass

Thru

K

UnisexLockerT443

Clean

Storage

Au

to-clave

Aut

o-cl

ave

ChangeToiletT444

K

Pas

sT

hru

Cart

Pass

Thru

Pass

Thru

EPass

Thru

K

QuarantinedMaterials

ReleasedMaterials

PlasmidBuffer

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Administration CubiclesRm 190

14.0' x 20.5'

QA ManagerOffice

Rm 17411.0' x 8.0'

Women's ToiletRm 187

12.0' x 11.7'Toilet Toilet Toilet

Men's ToiletRm 186

12.0' x 11.7'

Sink

ToiletUrinal Urinal

Sink

SinkSink

Retain SamplesRm 158

9.0' x 5.5'

Gown / Degown Rm 17022.0' x 8.0'

SterilityTesting ARm 172

10.0' x 23.0'

SterilityTesting BRm 173

10.0' x 23.0'

Access C

orridor C

Rm

102 101.0' x 6.0'

QC Lab 3Flow Cytometer

Rm 16812.0' x 30.0'


Rm 16212.0' x 30.0'

Patient CellIrradiation

Rm 1579.0' x 9.5'

Clean C

orridor B

Rm

104 42.5' x 6.0'

Clean C

orridor BR

m 104

23.0' x 6.0'

Clean C

orridor B R

m 104

46.0' x 6.0'

Clean C

orridor BR

m 104

16.5' x 6.0'

Personnel Entry Rm 12018.5' x 8.5'

Acc

ess

Cor

ridor

A R

m 1

00

66.0

' x

6.0'

Acc

ess

Cor

ridor

A R

m 1

00

57.5

' x

6.0'

Cle

an C

orrid

or A

R

m 1

03

25.5

' x

6.0'

Cle

an C

orrid

or A

Rm

103

37

.0'

x 6.

0'C

lean

Cor

ridor

A

Rm

103

44

.0'

x 6.

0'

Gown Corridor B Rm 107 52.0' x 6.0'

Prod

uctio

n 4

Rm

129

19

.0'

x 8.

0'

Prod

uctio

n 5

Rm

130

19

.0'

x 8.

0'

Prod

uctio

n 3

Rm

128

19

.0'

x 8.

0'

Prod

uctio

n 2

Rm

127

19

.0'

x 8.

0'

Production Support A 133 52.0' x 11.0'

Gown Corridor A Rm 106 52.0' x 6.0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownA

Rm 1326.0'

x 9.5'

Prod

uctio

n 1

Rm

126

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 6

Rm

131

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PTPTPT

Prod

uctio

n 10

Rm

137

19

.0'

x 8.

0'

Prod

uctio

n 11

Rm

138

19

.0'

x 8.

0'

Prod

uctio

n 9

Rm

136

19

.0'

x 8.

0'

Prod

uctio

n 8

Rm

135

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownB

Rm 1476.0'

x 10.0'

Prod

uctio

n 7

Rm

134

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 12

Rm

139

19

.0'

x 8.

0'

PT

R D

uct

R D

uct

R D

uct

R D

uct

PTPT R Duct

R Duct

Prod

uctio

n 16

Rm

144

19

.0'

x 8.

0'

Prod

uctio

n 17

Rm

145

19

.0'

x 8.

0'

Prod

uctio

n 15

Rm

143

19

.0'

x 8.

0'

Prod

uctio

n 14

Rm

142

19

.0'

x 8.

0'

Production Support B 148 52.0' x 11.0'

R D

uct

R D

uct

R D

uct

R D

uct

Prod

uctio

n 13

Rm

141

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 18

Rm

146

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PTPTPT

Prod

uctio

n 22

Rm

153

19

.0'

x 8.

0'

Prod

uctio

n 23

Rm

154

19

.0'

x 8.

0'

Prod

uctio

n 21

Rm

152

19

.0'

x 8.

0'

Prod

uctio

n 20

Rm

151

19

.0'

x 8.

0'

Gown Corridor C Rm 108 52.0' x 6.0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownC

Rm 1566.0'

x 10.0'

Prod

uctio

n 19

Rm

150

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 24

Rm

155

19

.0'

x 8.

0'

PT

R D

uct

R D

uct

R D

uct

R D

uct

PTPT R Duct

R Duct

Access Corridor B Rm 101 135.5' x 6.0'

Clean Corridor C Rm 105 78.0' x 6.0'

GownC

Rm 1496.0'

x 12.5'

GownB

Rm 1406.0'

x 12.5'

GownA

Rm 1256.0'

x 12.0'


11.5' x 13.0'ToiletToilet Toilet

Men's ToiletRm 115

11.5' x 13.0'

Sink

ToiletUrinal Urinal

Sink

SinkSink

Women's LockerRm 119

18.5' x 24.0'

Men's LockerRm 113

18.5' x 24.0'

Cle

an C

orrid

or A

Rm

103

19

.0'

x 6.

0'

Product ReleasePackagingRm 124

18.5' x 15.0'

CleanCloset

Rm 1225.8' x 10.0'

Janitor'sCloset

Rm 1215.8' x 10.0'

Ready Supplies AKit Assembly

Rm 110 18.5' x 25.5'

Release SuppliesRm 109 18.5' x 25.5'

Quarantine SuppliesRm 111 18.5' x 18.5'

ReceivingRm 114

18.5' x 10.0'

Truck DockRm 116

18.5' x 20.0'

ShippingRm 118

18.5' x 10.0'

Mechanical AreaRm 123

18.5' x 24.5'

Cold Room112

9.0' x 14.0'

Car

tPa

ssT

hru

Car

tPa

ssT

hru



Men's ToiletRm 164

12.5' x 11.7'

Sink

ToiletUrinal Urinal

Sink

SinkSink

Surrogate Culture 1Rm 161 19.5' x 12.0'

PT


PT


PT


PT

QC Lab 2Blastogenesis

Rm 16612.0' x 12.0'

9.0' x 5.0'

QC MicrobiologyEnvironmental

MonitoringRm 159

12.0' x 21.0'

QC MicroMaterialTestingRm 160

10.0' x 21.0'

Radio Isotope LabRm 171

16.0' x 8.0'

K

K

K

K

K

K

K

K

K

K

K

K

QA DocumentVault

Rm 17511.0' x 14.5'

PurchasingManager

OfficeRm 197

11.0' x 8.0'

QA / RA / Purchasing CubiclesRm 196

27.0' x 31.5'

Medical DirectorOffice

Rm 20111.0' x 9.0'

QA ManagerOffice

Rm 19811.0' x 8.0'

Copy / FaxRm 199

11.0' x 5.0'

Production / QC / EngineeringCubiclesRm 179

29.0' x 26.0'

FacilitiesDirectorOffice

Rm 1809.0' x 10.0'

Production DirectorOffice

Rm 17814.5' x 8.5'

Copy / FaxRm 181

9.0' x 5.0'

ProductionMangersOffice

Rm 17611.5' x 8.5'


Rm 17711.5' x 8.5'

QC DirectorOffice

Rm 1829.0' x 10.0'

Training / ConferenceRm 193

20.5' x 15.5'

BreakroomRm 183

22.5' x 19.5'

HR ManagerOffice

Rm 19511.0' x 8.0'

HR AssistantOffice

Rm 19411.0' x 7.0'

IMS ManagerOffice

Rm 1849.0' x 10.0'

ComputerCenter

Rm 1859.0' x 9.0'

Plant ManagerOffice

Rm 19211.0' x 12.0'

ExecutiveAssistant

OfficeRm 191

11.0' x 8.0'

ReceptionRm 188

19.0' x 8.5'

Janitor's ClosetRm 189

12.5' x 6.0'

QA DirectorOffice

Rm 20011.0' x 9.0'

6.0'

x 9

.0'

6.0'

x 1

6.0'

K

K

K

E

K

6.0'

x 1

9.5'

K

K

Room Layout - Total Facility Dimensions 188.5' x 134.0'E

E

E E

13.0' x 6.0'

WRT&A

Com

puter

Com

puterCom

pute

rCom

puterCom

pute

r

Com

puterCom

pute

rCom

puterCom

pute

rCom

puterCom

pute

r

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

StainlessTable

Flow

Cyt

omet

er

Administration CubiclesRm 190

14.0' x 20.5'

QA ManagerOffice

Rm 17411.0' x 8.0'


12.0' x 11.7'Toilet Toilet Toilet

Men's ToiletRm 186

12.0' x 11.7'

Sink

ToiletUrinal Urinal

Sink

SinkSink

Retain SamplesRm 158

9.0' x 5.5'

Gown / Degown Rm 17022.0' x 8.0'

SterilityTesting ARm 172

10.0' x 23.0'

SterilityTesting BRm 173

10.0' x 23.0'

Access C

orridor C

Rm

102 101.0' x 6.0'


Rm 16812.0' x 30.0'


Rm 16212.0' x 30.0'

Patient CellIrradiation

Rm 1579.0' x 9.5'

Clean C

orridor B

Rm

104 42.5' x 6.0'

Clean C

orridor BR

m 104

23.0' x 6.0'

Clean C

orridor B R

m 104

46.0' x 6.0'

Clean C

orridor BR

m 104

16.5' x 6.0'

Personnel Entry Rm 12018.5' x 8.5'

Acc

ess

Cor

ridor

A R

m 1

00

66.0

' x

6.0'

Acc

ess

Cor

ridor

A R

m 1

00

57.5

' x

6.0'

Cle

an C

orrid

or A

R

m 1

03

25.5

' x

6.0'

Cle

an C

orrid

or A

Rm

103

37

.0'

x 6.

0'C

lean

Cor

ridor

A

Rm

103

44

.0'

x 6.

0'

Gown Corridor B Rm 107 52.0' x 6.0'

Prod

uctio

n 4

Rm

129

19

.0'

x 8.

0'

Prod

uctio

n 5

Rm

130

19

.0'

x 8.

0'

Prod

uctio

n 3

Rm

128

19

.0'

x 8.

0'

Prod

uctio

n 2

Rm

127

19

.0'

x 8.

0'

Production Support A 133 52.0' x 11.0'

Gown Corridor A Rm 106 52.0' x 6.0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownA

Rm 1326.0'

x 9.5'

Prod

uctio

n 1

Rm

126

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 6

Rm

131

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PTPTPT

Prod

uctio

n 10

Rm

137

19

.0'

x 8.

0'

Prod

uctio

n 11

Rm

138

19

.0'

x 8.

0'

Prod

uctio

n 9

Rm

136

19

.0'

x 8.

0'

Prod

uctio

n 8

Rm

135

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownB

Rm 1476.0'

x 10.0'

Prod

uctio

n 7

Rm

134

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

PT PT PT

Prod

uctio

n 12

Rm

139

19

.0'

x 8.

0'

PT

R D

uct

R D

uct

R D

uct

R D

uct

PTPT R Duct

R Duct

Prod

uctio

n 16

Rm

144

19

.0'

x 8.

0'

Prod

uctio

n 17

Rm

145

19

.0'

x 8.

0'

Prod

uctio

n 15

Rm

143

19

.0'

x 8.

0'

Prod

uctio

n 14

Rm

142

19

.0'

x 8.

0'

Production Support B 148 52.0' x 11.0'

R D

uct

R D

uct

R D

uct

R D

uct

Prod

uctio

n 13

Rm

141

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

Prod

uctio

n 18

Rm

146

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

Prod

uctio

n 22

Rm

153

19

.0'

x 8.

0'

Prod

uctio

n 23

Rm

154

19

.0'

x 8.

0'

Prod

uctio

n 21

Rm

152

19

.0'

x 8.

0'

Prod

uctio

n 20

Rm

151

19

.0'

x 8.

0'

Gown Corridor C Rm 108 52.0' x 6.0'

R D

uct

R D

uct

R D

uct

R D

uct

DegownC

Rm 1566.0'

x 10.0'

Prod

uctio

n 19

Rm

150

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

Prod

uctio

n 24

Rm

155

19

.0'

x 8.

0'

R D

uct

R D

uct

R D

uct

R D

uct

R Duct

R Duct

Access Corridor B Rm 101 135.5' x 6.0'

Clean Corridor C Rm 105 78.0' x 6.0'

GownC

Rm 1496.0'

x 12.5'

GownB

Rm 1406.0'

x 12.5'

GownA

Rm 1256.0'

x 12.0'



Men's ToiletRm 115

11.5' x 13.0'

Sink

ToiletUrinal Urinal

Sink

SinkSink

Women's LockerRm 119

18.5' x 24.0'

Men's LockerRm 113

18.5' x 24.0'C

lean

Cor

ridor

AR

m 1

03

19.0

' x

6.0'

Product ReleasePackagingRm 124

18.5' x 15.0'

CleanCloset

Rm 1225.8' x 10.0'

Janitor'sCloset

Rm 1215.8' x 10.0'

Ready Supplies AKit Assembly

Rm 110 18.5' x 25.5'

Release SuppliesRm 109 18.5' x 25.5'

Quarantine SuppliesRm 111 18.5' x 18.5'

ReceivingRm 114

18.5' x 10.0'

Truck DockRm 116

18.5' x 20.0'

ShippingRm 118

18.5' x 10.0'

Mechanical AreaRm 123

18.5' x 24.5'

Cold Room112

9.0' x 14.0'

Car

tPa

ssT

hru

Car

tPa

ssT

hru



Men's ToiletRm 164

12.5' x 11.7'

Sink

ToiletUrinal Urinal

Sink

SinkSink


PT



PT


PT

QC Lab 2Blastogenesis

Rm 16612.0' x 12.0'

9.0' x 5.0'

QC MicrobiologyEnvironmental

MonitoringRm 159

12.0' x 21.0'

QC MicroMaterialTestingRm 160

10.0' x 21.0'

Radio Isotope LabRm 171

16.0' x 8.0'

K

K

K

K

K

K

K

K

K

K

K

K

QA DocumentVault

Rm 17511.0' x 14.5'

PurchasingManager

OfficeRm 197

11.0' x 8.0'

QA / RA / Purchasing CubiclesRm 196

27.0' x 31.5'

Medical DirectorOffice

Rm 20111.0' x 9.0'

QA ManagerOffice

Rm 19811.0' x 8.0'

Copy / FaxRm 199

11.0' x 5.0'

Production / QC / EngineeringCubiclesRm 179

29.0' x 26.0'

FacilitiesDirectorOffice

Rm 1809.0' x 10.0'

Production DirectorOffice

Rm 17814.5' x 8.5'

Copy / FaxRm 181

9.0' x 5.0'


Rm 17611.5' x 8.5'


Rm 17711.5' x 8.5'

QC DirectorOffice

Rm 1829.0' x 10.0'

Training / ConferenceRm 193

20.5' x 15.5'

BreakroomRm 183

22.5' x 19.5'

HR ManagerOffice

Rm 19511.0' x 8.0'

HR AssistantOffice

Rm 19411.0' x 7.0'

IMS ManagerOffice

Rm 1849.0' x 10.0'

ComputerCenter

Rm 1859.0' x 9.0'

Plant ManagerOffice

Rm 19211.0' x 12.0'

ExecutiveAssistant

OfficeRm 191

11.0' x 8.0'

ReceptionRm 188

19.0' x 8.5'

Janitor's ClosetRm 189

12.5' x 6.0'

QA DirectorOffice

Rm 20011.0' x 9.0'

6.0'

x 9

.0'

6.0'

x 1

6.0'

K

K

K

E

K

6.0'

x 1

9.5'

K

K

Equipment Layout - Total Facility Dimensions 188.5' x 134.0'E

E

E E

13.0' x 6.0'

Towels

Towels

LaboratoryCasework

FlowC

ytometer

LaboratoryC

asework

FlowC

ytometer

LaboratoryCasework

Flow

Cyt

omet

erSi

nk

Double D

oorR

efrigerator

LaboratoryCasework

SS WireShelving

Computer

SS WireShelving

IPAWash

SoiledGowns

6ft

Bio

safe

tyO

vr/U

ndC

O2

Incu

bato

rR

efrig

erat

or

Cent

R D

uct

Cart

Cent

6ft

Bio

safe

ty

Cent

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

Cent

6ft

Bio

safe

tyO

vr/U

ndC

O2

Incu

bato

rR

efrig

erat

or

Cent Cent

6ftB

iosafetyO

vr/Und

CO

2Incubator

Refrig

erator

CentCent

6ft

Bio

safe

tyO

vr/U

ndC

O2

Incu

bato

rR

efrig

erat

or

Cent Cent

6ftB

iosafetyO

vr/Und

CO

2Incubator

Refrig

erator

Cent Cent

CellCounter

Computer

SS WireShelving

Computer

IPAWash

SoiledGowns

6ft

Bio

safe

tyO

vr/U

ndC

O2

Incu

bato

rR

efrig

erat

or

CentCent

6ftB

iosafetyO

vr/Und

CO

2Incubator

Refrig

erator

CentCent

6ft

Bio

safe

tyO

vr/U

ndC

O2

Incu

bato

rR

efrig

erat

or

CentCent

6ft

Bio

safe

ty

Cent

Ovr/U

ndC

O2

IncubatorR

efrigerator

Car

t

Cent

Com

pute

r6f

tB

iosa

fety

Cent

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

Cent

6ftB

iosafetyO

vr/Und

CO

2Incubator

Refrig

erator

CentCent

CellCounter

CellCounter

CellCounter

SS WireShelving

SS WireShelving

Computer

SS WireShelving

Com

pute

r6f

tB

iosa

fety

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

StainlessTable Cent

R D

uct

Cart

Cent

Com

puter

StainlessTable

6ft

Bio

safe

ty

Cent

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

Cent

Com

pute

r6f

tB

iosa

fety

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

StainlessTableCent Cent

Com

puter6ft

Biosafety

Ovr/U

ndC

O2

IncubatorR

efrigerator

StainlessTable CentCent

Com

pute

r6f

tB

iosa

fety

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator


Com

puter6ft

Biosafety

Ovr/U

ndC

O2

IncubatorR

efrigerator


CellCounter

Computer

SS WireShelving

Computer

Com

pute

r6f

tB

iosa

fety

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator


Com

puter6ft

Biosafety

Ovr/U

ndC

O2

IncubatorR

efrigerator


Com

pute

r6f

tB

iosa

fety

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator


Com

puter

StainlessTable

6ft

Bio

safe

tyCent

Ovr/U

ndC

O2

IncubatorR

efrigerator

Car

tCent

Com

pute

r

StainlessTable

6ft

Bio

safe

ty

Cent

Ovr

/Und

CO

2In

cuba

tor

Ref

riger

ator

Cent

Com

puter6ft

Biosafety

Ovr/U

ndC

O2

IncubatorR

efrigerator


CellCounter

CellCounter

CellCounter

SS WireShelving

Bench

Mirror

IPAW

ash

Wir

eSh

elvi

ng

Bench

Mirror

IPA

Was

h

Wir

eSh

elvi

ng Bench

Mirror

Towels

Towels

IPAW

ash

Wir

eSh

elvi

ng

Stainless Steel WireShelving

Stai

nles

sTa

ble

Double DoorRefrigerator

Free

zer

Cart Cart

Lock

ers

Cle

an S

crub

s

Lockers

Bench

Lockers

Ben

ch

Bench

StorageC

abinet

Sink Sink

Stor

age

Cab

inet

Com

pute

r

Computer

Computer

Com

puter

Shelving

ShelvingTabl

e

Stee

l She

lvin

g

Steel ShelvingShelving

Shelving

FreezerC

omputer

Freezer

Pack

age

Was

teTa

ble

Cart

Cart

Car

tC

art

Stai

nles

sTa

ble

StorageCabinet

Storage Cabinet

StainlessTable

Shelving

Car

t

Microscope

Microscope

Microscope

Microscope

Microscope

Microscope

Microscope

Microscope

Double DoorRefrigerator

Free

zer


StainlessTable

Stai

nles

sTa

ble


Com

pute

r

Cart

Coat Storage

CellIrradia

tor

Towels

Towels

6ftBiosafety

Ovr/UndCO2

Incubator6ft

Biosafety

6ftBiosafety

Ovr/UndCO2

Incubator

6ftBiosafety

6ftBiosafety

Ovr/UndCO2

Incubator6ft

Biosafety

6ftBiosafety

Ovr/UndCO2

Incubator

6ftBiosafety

6ftBiosafety

Ovr/UndCO2

Incubator6ft

Biosafety

6ftBiosafety

Ovr/UndCO2

Incubator

6ftBiosafety

6ftBiosafety

Ovr/UndCO2

Incubator6ft

Biosafety

6ftBiosafety

Ovr/UndCO2

Incubator

6ftBiosafety

FlowC

ytometer

LaboratoryC

asework

FlowC

ytometerLaboratory

Casework

Flow

Cyt

omet

erFl

owC

ytom

eter

Sink

Double D

oorR

efrigerator

LaboratoryCasework

LaboratoryCasework

Mic

rosc

ope

Mic

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