planning and organizing for pharma manufacturing facility construction

8/9/2019 Planning and Organizing for Pharma Manufacturing Facility Construction

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Planning and Organizing

for Pharmaceutical

Manufacturing Facility

onstruction



• Stringent Mandatory GovernmentRegulatory Requirements

• Market Demand to Reduce Cost

• Increase Efficiency

• New Technology

Forces Affecting the Region



Requirement

Upgrade facilities orconstruct new

ones designed tohigher standards

of constructionand technology



Objectives

• PICS cGMP compliant

• Multi-product/Dedicated/ Segregated

• Flexible

• Compact

• Local / National Building Compliant

• Safe and Environment Friendly

• Controlled Cost



• Change Control Initiation Form,Form 02v-001

• Review of Major/Critical Changes Form,Form 02v-002

Change

Type CodeType of change Critical Major Minor

C4Change in manufacturing location / new or

renovated facility √

• Change Control Committee

• Validation Committee• Risk Management Committee



• Impact Assessment• Conditions to be fulfilled

• Impact on sites SOPs, batch and documentation

• Impact on supply

• Training of Personnel

• Responsibilities

• Cleaning Validation

• Process Validation

• Equipment Qualification

• Safety• Cost

• Regulatory impact

• Downstream impact on customers

• Priority

• Timeline



• Recommended Consequent Actions• Document Change (Lay-out, Room Book, SMF, SVMP, SOPs,

SOIs, EMF, UMF, IMF etc.)• Training

• Regulatory Action/ variation application

• Allocate budget and resources

• Customer approval

• Qualification/requalification

• Process Validation

• Room Temperature Profiling• Cleaning Validation

• Increased Testing / Sampling

• Trial production batch

• Laboratory experiment



Stages

• Strategic Planning

• Conceptual Design

• Detailed Design and Engineering

• Pre-construction

• Construction / Installation

• Commissioning

• Acceptance



Manufacturing Strategic Planning

• Policies, goals and objectives clearly defined

• Identify the products and product risks

• Process requirements and process risks

• Product lines and volume requirements• Cost drivers

• Capacities, flexibility and technology• Organization in the facility

• Schedule



Teams Identified



Validation Team

• Initially the team consist of;

• Construction Manager• Production Manager (end

user of the facility)

• Plant Engineer (end userof the facility)

• QA Manager / Validation

Manager

• JM Tolmann Validation Team

• Managing Director• QA Validation Supervisor

• Production Supervisor• QC Supervisor

• MSD In-Charge



Conceptual Design Team

• Facility engineers andproduction managers who

are projected to use thefacility when finished.



Detailed Design EngineersTeam

• Architect• Civil Engineer

• Mechanical Engineer

• Electrical Engineer• Sanitary Engineer



Construction Management Team

• Civil Engineer• Mechanical Engineer

• Electrical Engineer

• Sanitary Engineer



Conceptual Design

• Process Requirements

• Process Line/Equipment

• Material Requirements

• Utility Requirements

• Operating Cost• Safety and Environmental



Conceptual Design

• Facility Requirements(number and areas of functional areas required)

• Process and production

• Materials receipt, dispatch,staging, storage

• Mechanical utilities andmaintenance

• Personnel related activities



Conceptual Design

• Room Book• Classification

• Occupancy

• Dimension• Architectural Finishes

• Access Requirements

• Floor Loading• Environmental Factors

• Utilities and Services

• Safety

• Fixed Furniture

• Equipment



Building Cephalosporin Series No. 13RBDS01

Storey 1 Reference Drawing No.

Room No. 111 Working hours 8 hrs /shift

Room description Bottle Blowing Room Class D

General Room Data Fittings Data

Length (m) 2.39 Flooring Epoxy finished, coved sides

Width (m) 1.90 Walls Concrete

Clearance height (m) 2.44 Ceiling False ceiling, hardiflex Area (m2) 4.54 Paint color White, Semi-gloss latex

Room volume (m3) 11.68 Number of doors 1

Number of Persons 1 Type of doors Wooden Sliding Door

Number of Equipment 1 Doors locked N/A

Room Conditions Number of windows N/A

Temperature (oC) 24 Type of windows N/A

Relative Humidity (%) 62 Utilities

Pressure differential Purified water None

Air exchange (1/h) Compressed air 1

Noise level dB(A) HVAC 1

Room Book Data Sheets

Form 02v-030



Monitoring Instrument Others

Thermohygrometer None Air Conditioning Units (#, HP) None

Thermometer None Electric Fan None

Magnehelic None Tap Water Supply None

Pressure Gauge 1 Cabinet 1

Electro/Data Technology Table (Number, Type) None

Gen. room lighting (Lux) Chair/Bench (Number, Type) None

Lamps (Number, Watts) 1 Hood Outlet None

Light switches (Number) 1 Hatch None

Sockets 110V (Number, Ph) Louver None

Sockets 220V (Number, Ph) 1Ph,3Ph Ladder None

Telephone (Local Number) None Ceiling Manhole None

Paging system None Safety

LAN/Internet outlet None Emergency Light None

CCTV None Smoke Detector None

Control Panel None Fire Exit None

Sanitary System Fire Extinguisher None

Floor drains 1 Safety Shower NoneSink / Wash Basin None First Aid Kit / Cabinet None

Equipment/s (Manufactur ing, Laboratory, Office)

Bottle Blowing Machine

Name Signature Date

Compiled by

Checked by

Released by



Conceptual Design

• Site Inspection• Soil Information

• Topography

• Existing Structures• Access

• Circulation

• Site Services

• Any planning constraints



Conceptual Design

• Design Concepts

CONCEPTS

CONCEPTS

CONCEPTS PROJECT

GOALS REFINE SELECT



Conceptual Design

• Final Design Scheme• Include detailed layouts of buildings,

process equipment, areaclassifications and preliminary HVACutilities

• Cost Estimate



GMP Zonal Concept

AREA DEFINITION COMMENT

WarehouseOfficesLaboratoriesSecondary Packaging

Not defined -

Production PrimaryPackaging

Rooms and equipmentaccording to therequirements of the EUGMP Guideline,

Chapter 3

Standard arrangementFilter correspondswith room Class D, butwith regular monitoring

Sterile Production Class A, B, C, D See EU GMP Guideline



Technical Details for the Layout of

RoomsVentilationTechnology

Filter stages, pressure characteristics, airexchange, air flow

Components Walls, doors, ceilings, floors, windows

Layout Personnel and material locks (PAL, MAL), Materialand Personnel Flow

Other buildingservices

Gases, Water, Waste Water, Plumbing, Lighting

Control Systems for Pressure differential, temperature, moisture,particles

Equipment Cleanability and sterility; no shedding of wear debris,oil, particles, microorganisms; ease of operation,maintenance and repair



Detailed Design & Engineering

• Detailed engineering, lay-

out and specifications• Architectural

• Structural• Mechanical

• Electrical• Sanitary

• Process



Pre-construction

• Review of design and specifications

• Qualification of suppliers,contractors, materials, prototypes

of design• Bidding and negotiation

• Final project cost estimate• Contracts review and signing

• Secure Permits



Construction/Installation

• Monitoring, inspection and evaluation

of materials, construction andinstallation

• Coordinate work• Schedule delivery of materials,

equipment, labor



Commissioning

• Tests

• Test Runs• Calibration



Acceptance

• Completion of tests, test runsand calibration

• Conformance to design anddefined specifications

• Secure permits and licenses• Regulatory agency approval



Stages

• Strategic Planning

• Conceptual Design

• Detailed Design and Engineering• Pre-construction

• Construction /Installation• Commissioning

• Acceptance



PLANNING

DQ

VENDOR QUALIFICATION

TESTING IQ

TESTING OQ

FINAL RESULTS

STRATEGIC PLANNING

CONCEPTUAL DESIGN

DETAILED DESIGN & ENG’R

PRECONSTRUCTION

CONSTRUCTION AND

INSTALLATION

COMMISSIONING

ACCEPTANCE

VALIDATION PLANNING AND CONSTRUCTION

• VMP

• GMP Critical Reviews

• Requirement Analysis

• User Requirements

• Risk Assessment

• Functional Specification

planning and organizing for pharma manufacturing facility construction

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