planning and organizing for pharma manufacturing facility construction

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 1/33

Page 1

Planning and Organizing

for Pharmaceutical

Manufacturing Facility

  onstruction

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 2/33

Page 2

• Stringent Mandatory GovernmentRegulatory Requirements

• Market Demand to Reduce Cost

• Increase Efficiency

• New Technology

Forces Affecting the Region

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 3/33

Page 3

Requirement

Upgrade facilities orconstruct new

ones designed tohigher standards

of constructionand technology

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 4/33

Page 4

Objectives

• PICS cGMP compliant

• Multi-product/Dedicated/ Segregated

• Flexible

• Compact

• Local / National Building Compliant

• Safe and Environment Friendly

• Controlled Cost

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 5/33

Page 5

• 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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 6/33Page 6

• 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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 7/33Page 7

• 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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 8/33

Page 8

Stages

• Strategic Planning

• Conceptual Design

• Detailed Design and Engineering

• Pre-construction

• Construction / Installation

• Commissioning

• Acceptance

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 9/33

Page 9

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 10/33

Page 10

Teams Identified

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 11/33

Page 11

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 12/33

Page 12

Conceptual Design Team

• Facility engineers andproduction managers who

are projected to use thefacility when finished.

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 13/33

Page 13

Detailed Design EngineersTeam

• Architect• Civil Engineer

• Mechanical Engineer

• Electrical Engineer• Sanitary Engineer

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 14/33

Page 14

Construction Management Team

• Civil Engineer• Mechanical Engineer

• Electrical Engineer

• Sanitary Engineer

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 15/33

Page 15

Conceptual Design

• Process Requirements

• Process Line/Equipment

• Material Requirements

• Utility Requirements

• Operating Cost• Safety and Environmental

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 16/33

Page 16

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 17/33

Page 17

Conceptual Design

• Room Book• Classification

• Occupancy

• Dimension• Architectural Finishes

• Access Requirements

• Floor Loading• Environmental Factors

• Utilities and Services

• Safety

• Fixed Furniture

• Equipment

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 18/33

Page 18

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 19/33

Page 19

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 20/33

Page 20

Conceptual Design

• Site Inspection• Soil Information

• Topography

• Existing Structures• Access

• Circulation

• Site Services

• Any planning constraints

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 21/33

Page 21

Conceptual Design

• Design Concepts

CONCEPTS

CONCEPTS

CONCEPTS  PROJECT

GOALS  REFINE   SELECT

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 22/33

Page 22

Conceptual Design

• Final Design Scheme• Include detailed layouts of buildings,

process equipment, areaclassifications and preliminary HVACutilities

• Cost Estimate

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 23/33

Page 23

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 24/33

Page 24

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 25/33

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 26/33

Page 26

Detailed Design & Engineering

• Detailed engineering, lay-

out and specifications• Architectural

• Structural• Mechanical

• Electrical• Sanitary

• Process

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 27/33

Page 27

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 28/33

Page 28

Construction/Installation

• Monitoring, inspection and evaluation

of materials, construction andinstallation

• Coordinate work• Schedule delivery of materials,

equipment, labor

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 29/33

Page 29

Commissioning

• Tests

• Test Runs• Calibration

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 30/33

Page 30

 Acceptance

• Completion of tests, test runsand calibration

• Conformance to design anddefined specifications

• Secure permits and licenses• Regulatory agency approval

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 31/33

Page 31

Stages

• Strategic Planning

• Conceptual Design

• Detailed Design and Engineering• Pre-construction

• Construction /Installation• Commissioning

• Acceptance

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 32/33

Page 32

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

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

http://slidepdf.com/reader/full/planning-and-organizing-for-pharma-manufacturing-facility-construction 33/33

Page 33