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VALIDATION SERVICES & LAB FURNITURE INSTALLATION DIVISION
PHARMA CONSULTING, CORP. was founded July 22, 2003. It is a multidisciplinary and net Puerto Rican company which offers professional services of validation to pharmaceutical businesses. The services will be directed to the areas of Engineering, Manufacture, Utilities, Processes, Laboratories and other.
Our personnel are prepared in the pharmaceutical field with extensive experience in different areas.
Pharma Consulting, Corp. personnel is totally trained and certified to work in any pharmaceutical company that requires of its services.
Pharma Consulting, Corp. is a business strictly dedicated to insure that every company regulated by the FDA does not commit irregularities that may damage the quali ...ty of the pharmaceutical products marketed inside and out of our country.
Our Validation Corp. maintains a staff of specialists dedicated to providing outstanding validation services to client companies. These services are aimed at compliance of regulatory requirements such as the Current Manufacturing Practices for Finished Pharmaceuticals (21 CFR 211); the Good Manufacturing Practices for Medical Devices (21 CFR 820) of the Federal Food, Drug and Cosmetic Act; the Guide to Inspection of Computerized Systems in Drug Processing; and related Compliance Policy Guides as required by the United States Food and Drug Administration.
The Validation Corp. assembled by PCC is a group of specialists with extensive experience in the validation of pharmaceutical, bulk chemical and medical devices facilities. We offer complete validation services, from planning through document preparation, field execution and final reporting.
The Validation Services Corp. frequently teams with our Validation staff to provide clients with a complete, fully comprehensive validation program that addresses all concerns from a regulatory perspective. Additionally, on projects that we design, our validation experts are available for consulting to ensure that the design meets all regulatory requirements before construction, thus assuring a fully validated facility when construction is complete.
The PCC expertise is derived from many years of experience in the pharmaceutical industry, as well as diverse project experience. We strongly believe that to ensure a system is validated in the shortest time, in a cost effective manner, and remains validated during operation,
the validation process must begin in the design phase and continue through implementation and start-up. This is called the life-cycle approach. It requires close interface and coordination among the designers, vendors and validation team.
Along with our validation capability, we apply strong project management and technical skills to the validation approach. This enhances our validation capability by making it more cost effective and schedule oriented, and, at the same time, insuring validation work of the highest quality.
Specifically, our designed and executed validation program will:
Minimize the number of documents subject to regulatory review
Confirm by documentation that the facility, equipment, computer system or process meets the specifications
Demonstrate that the facility, equipment, computer system or process is in compliance with regulatory requirements
Provide professional training of plant operators, supervisors, and maintenance personnel
Provide criteria for the development and certification of sound maintenance and calibration program
We can customize our services to fit your specific personnel needs or provide you with a complete turnkey validation program. We work closely with you to achieve the ultimate goal of providing a validated/certified facility, equipment, computer system or process ready to manufacture your product as quickly and as cost-effectively as possible.
We can provide a complete validation staff to perform all validation procedures. Or, if desired, we can perform validation services on a stand-alone basis, working with your staff to supplement or complement their efforts.
Manufacturing companies can rely on PCC for a wide spectrum of contract services based on the following:
Personnel with over fifteen (15) years of average validation experience in Puerto Rico
Fully trained personnel
Personalized One-To-One communication with our clients
Timely status/review report
Top quality service, yet cost effective
Our Experience:
Retrospective validation
CAPA
Statistical process control & analysis
Packaging lines
CGMP/GLP compliance
Bulk sterilization systems
Components preparation
Computer Validation
Method Validation And Optimization Parentherals
Liquid/Solid Dosage Forms
Bulk Pharmaceutical Chemicals
QA/QC testing laboratories
Transfer technology
New product start-up
Pharmaceutical air, water handling systems
HVAC systems
Utilities (compressed gases, steam, chilled water systems, etc.)
Cleaning validation, CIP, SIP
Sterilizers (steam, ETO, gamma, dry heat)
Dehydrogenation (rinsing or dry heat)
Laboratory equipment (stability ovens, incubators, refrigerators, walk-in inc., etc.)
Filter integrity test equipment
Laminar flow pattern evaluation
Our Services:
Regulatory consulting services
Develop validation Master Plans
Develop qualification documents (installation, operational, performance protocols including mechanical and computer validation)
Define process/system requirements (equipment, procedure, specifications, etc.)
Evaluate GMP/GLP requirements (including SOPs, forms or general documentation)
Troubleshooting of pharmaceutical needs
Change control assessment
Quality audits as part of the on going system evaluation (Life Cycle Approach)
Customized seminars on selected validation topics to fit the client expectations.
I Laboratory:
Depending on our clients requests and requirements, we offer the
following professional services:
Laboratory Technician
Laboratory Analyst
Laboratory Analyst licensed
Senior Laboratory Analyst
PhD
Develop and Execute IOPQ for laboratory instruments
Raw Material, Finished Products, Incoming, In Process, products, Stability.
Develop Standard Operation Procedures (SOPs to assure the control process).
Execute and evaluate Analytical and Cleaning Validations and Method Transfer.
Pharmacopeias USP, EP, JP, FCC and ICH.
Knowledge of cGMPs GLP, GCP or (GXP).
Experienced in equipment validation of all brands in the industry.
Atomic Absorption, Fluorescents Spectrometry, Micro Centrifuges,
Water Purifications, Analytical balance, Dionne, Refractometer, Autoclaves, Polarimeter, UV/VIS, Conduct meter, Freezer, Refrigerators, Incubators, Balance, Fume Hoods, Pipettes, Centrifuges, Electrophoresis, GC, HPLC, FTIR, Thermal Analyzer, Dissolution Bath, Humidity Chamber, Washers,TOC- Sievers (Data Guard Software), Karl Fisher, Coulometer, Chemstation, Zymark TPW 11, Multydose System, Reverse Osmosis, NIR System, Water Pro, Ultrasonic Bath-Branson
Calibration, Verification and Functionality Computer and General Use
Instrument Operational and Calibration Training
Software Validation development
Gauge calibration verification
Electronic Calibration Verification
II - Method Validation and Optimization:
Equipment, Computer, Cleaning and Process Validations
Accuracy
Precision
Specificity
Detection Limit
Quantification Limit
Stability of Solutions
Linearity and Range
Ruggedness
Robustness
System Suitability
III - Solid Oral Dosage:
Equipment, Computer, Cleaning and Process Validations
Blenders
High Shear, Tumbler, and Conical Mixers
Fluid Bed Dryers
Milling Equipment
Check Weighers
Tablet Presses
Tablet Coaters
Tablet Printers
Samples Testers (densities, particle size, etc.)
Isolators
Laboratory equipment
Microwave Drying
Pumps (Centrifugal and Diaphragm)
Capsule Machines
Compactors
Solution Preparation Systems And Tanks
Granulators/ Dust Collector
Vertical Manufacturing Trains
Auto Test 4 Pharmatron Tablet Tester (AT4)
Metal Detectors
CIP And WIP Systems
IV Packaging:
Equipment, Computer, Cleaning and Process Validations
Unscramblers
Fillers
Cappers
Labelers
Batch/Date/Bar Coders
Blister Packers
Accumulation Tablets
Cartonners
Wrappers
Sealers
Palletizers
Cottonners
Retorquers
Casepackers
Conveyors
Controls and Indicators
V Utilities:
Equipment, Computer and Process Validations
HVAC Systems
Clean Steams
Plant Steams
Purified Water
Chiller Water Systems
Jacket Vessels
Heat Exchangers
Vacuum
Emergency Power
Water for Injection
Sterile Air
Compressed Air
Plant Air
Air and Water Quality Monitoring
Nitrogen
Dust Collection
VI Facilities:
Equipment, Computer, Cleaning and Process Validation
Compounding / Formulation
Aseptic Suites
Laboratories
Controlled Substances
Environmental Rooms
Containment Areas
Medical Devices
Barrier Technology
VII Bulk Pharmaceuticals:
Equipment, Computer and Process Validation
Reactors
Solvent Recovery
Distillation Columns
Crystallizers
Extruders
Filtration
Drying
Holding Tanks
Tank Farms
Vessels / Agitators
VIII - Computer System Validation:
Equipment, Computer, Cleaning and Process Validations
Computer Validation and Audit Trail
Data Security and Integrity
CAPAs Plans
Retention of Electronics Records
Modification of Legacy Systems
Passwords, ID Codes an signatures
Problems Areas Like:
Database Queries
Handwrite FDA
Media Access
Hybrid Systems
Our Services Include:
Lab Furniture Installation Division:
PCC offers professional, factory-trained installers with comprehensive knowledge of furniture components and extensive experience to assure fast, trouble-free installations.
Our Clients:
Clients (Validation Services)
Abbott Fermentation Products
Abbott Laboratory
Abbott Diagnostic
Bristol Myers-Squibb
Bio Vail
VWR International
Cardinal Health Plans
Johnson & Johnson Pharmaceuticals Partners
Lilly Del Caribe
Jacobs
Watson Laboratories
Wyeth Guayama
Wyeth Carolina
I VAX CIDRA
ST. CROIX
Tyco Healthcare ( USSC ) - Ponce
Clients (Installation Services)
Schering Plough Manati
Schering Plough Las Piedras
Baxter Jayuya
Bristol Barceloneta
Abbott Jayuya
Boston scientific Miami
Baxter Maricao
Bristol Mayaguez
Baxter Maricao
Bristol Manati
Colegio Marista
Hewlett Packard
ICN Humacao
I Vax
Janssen
Watson
Lilly Mayaguez
Mc Neil
Ortho
Schering Plough
UPR Ponce
UPR Mayaguez
Johnson & Johnson
University Puerto Rico Mayaguez, Rio Piedras, Cayey
ON SITE PROJECT MANAGEMENT SERVICES
Pharma Consulting Corp. (PCC) can supply client project management needs by providing on site resources. Our experienced project management group can provide the following services:
Overall project supervision
Project scheduling
Cost control
Technical coordination and inspection
Subcontractors work supervision and coordina Read more
PHARMA CONSULTING, CORP. was founded July 22, 2003. It is a multidisciplinary and net Puerto Rican company which offers professional services of validation to pharmaceutical businesses. The services will be directed to the areas of Engineering, Manufacture, Utilities, Processes, Laboratories and other.
Our personnel are prepared in the pharmaceutical field with extensive experience in different areas.
Pharma Consulting, Corp. personnel is totally trained and certified to work in any pharmaceutical company that requires of its services.
Pharma Consulting, Corp. is a business strictly dedicated to insure that every company regulated by the FDA does not commit irregularities that may damage the quali ...ty of the pharmaceutical products marketed inside and out of our country.
Our Validation Corp. maintains a staff of specialists dedicated to providing outstanding validation services to client companies. These services are aimed at compliance of regulatory requirements such as the Current Manufacturing Practices for Finished Pharmaceuticals (21 CFR 211); the Good Manufacturing Practices for Medical Devices (21 CFR 820) of the Federal Food, Drug and Cosmetic Act; the Guide to Inspection of Computerized Systems in Drug Processing; and related Compliance Policy Guides as required by the United States Food and Drug Administration.
The Validation Corp. assembled by PCC is a group of specialists with extensive experience in the validation of pharmaceutical, bulk chemical and medical devices facilities. We offer complete validation services, from planning through document preparation, field execution and final reporting.
The Validation Services Corp. frequently teams with our Validation staff to provide clients with a complete, fully comprehensive validation program that addresses all concerns from a regulatory perspective. Additionally, on projects that we design, our validation experts are available for consulting to ensure that the design meets all regulatory requirements before construction, thus assuring a fully validated facility when construction is complete.
The PCC expertise is derived from many years of experience in the pharmaceutical industry, as well as diverse project experience. We strongly believe that to ensure a system is validated in the shortest time, in a cost effective manner, and remains validated during operation,
the validation process must begin in the design phase and continue through implementation and start-up. This is called the life-cycle approach. It requires close interface and coordination among the designers, vendors and validation team.
Along with our validation capability, we apply strong project management and technical skills to the validation approach. This enhances our validation capability by making it more cost effective and schedule oriented, and, at the same time, insuring validation work of the highest quality.
Specifically, our designed and executed validation program will:
Minimize the number of documents subject to regulatory review
Confirm by documentation that the facility, equipment, computer system or process meets the specifications
Demonstrate that the facility, equipment, computer system or process is in compliance with regulatory requirements
Provide professional training of plant operators, supervisors, and maintenance personnel
Provide criteria for the development and certification of sound maintenance and calibration program
We can customize our services to fit your specific personnel needs or provide you with a complete turnkey validation program. We work closely with you to achieve the ultimate goal of providing a validated/certified facility, equipment, computer system or process ready to manufacture your product as quickly and as cost-effectively as possible.
We can provide a complete validation staff to perform all validation procedures. Or, if desired, we can perform validation services on a stand-alone basis, working with your staff to supplement or complement their efforts.
Manufacturing companies can rely on PCC for a wide spectrum of contract services based on the following:
Personnel with over fifteen (15) years of average validation experience in Puerto Rico
Fully trained personnel
Personalized One-To-One communication with our clients
Timely status/review report
Top quality service, yet cost effective
Our Experience:
Retrospective validation
CAPA
Statistical process control & analysis
Packaging lines
CGMP/GLP compliance
Bulk sterilization systems
Components preparation
Computer Validation
Method Validation And Optimization Parentherals
Liquid/Solid Dosage Forms
Bulk Pharmaceutical Chemicals
QA/QC testing laboratories
Transfer technology
New product start-up
Pharmaceutical air, water handling systems
HVAC systems
Utilities (compressed gases, steam, chilled water systems, etc.)
Cleaning validation, CIP, SIP
Sterilizers (steam, ETO, gamma, dry heat)
Dehydrogenation (rinsing or dry heat)
Laboratory equipment (stability ovens, incubators, refrigerators, walk-in inc., etc.)
Filter integrity test equipment
Laminar flow pattern evaluation
Our Services:
Regulatory consulting services
Develop validation Master Plans
Develop qualification documents (installation, operational, performance protocols including mechanical and computer validation)
Define process/system requirements (equipment, procedure, specifications, etc.)
Evaluate GMP/GLP requirements (including SOPs, forms or general documentation)
Troubleshooting of pharmaceutical needs
Change control assessment
Quality audits as part of the on going system evaluation (Life Cycle Approach)
Customized seminars on selected validation topics to fit the client expectations.
I Laboratory:
Depending on our clients requests and requirements, we offer the
following professional services:
Laboratory Technician
Laboratory Analyst
Laboratory Analyst licensed
Senior Laboratory Analyst
PhD
Develop and Execute IOPQ for laboratory instruments
Raw Material, Finished Products, Incoming, In Process, products, Stability.
Develop Standard Operation Procedures (SOPs to assure the control process).
Execute and evaluate Analytical and Cleaning Validations and Method Transfer.
Pharmacopeias USP, EP, JP, FCC and ICH.
Knowledge of cGMPs GLP, GCP or (GXP).
Experienced in equipment validation of all brands in the industry.
Atomic Absorption, Fluorescents Spectrometry, Micro Centrifuges,
Water Purifications, Analytical balance, Dionne, Refractometer, Autoclaves, Polarimeter, UV/VIS, Conduct meter, Freezer, Refrigerators, Incubators, Balance, Fume Hoods, Pipettes, Centrifuges, Electrophoresis, GC, HPLC, FTIR, Thermal Analyzer, Dissolution Bath, Humidity Chamber, Washers,TOC- Sievers (Data Guard Software), Karl Fisher, Coulometer, Chemstation, Zymark TPW 11, Multydose System, Reverse Osmosis, NIR System, Water Pro, Ultrasonic Bath-Branson
Calibration, Verification and Functionality Computer and General Use
Instrument Operational and Calibration Training
Software Validation development
Gauge calibration verification
Electronic Calibration Verification
II - Method Validation and Optimization:
Equipment, Computer, Cleaning and Process Validations
Accuracy
Precision
Specificity
Detection Limit
Quantification Limit
Stability of Solutions
Linearity and Range
Ruggedness
Robustness
System Suitability
III - Solid Oral Dosage:
Equipment, Computer, Cleaning and Process Validations
Blenders
High Shear, Tumbler, and Conical Mixers
Fluid Bed Dryers
Milling Equipment
Check Weighers
Tablet Presses
Tablet Coaters
Tablet Printers
Samples Testers (densities, particle size, etc.)
Isolators
Laboratory equipment
Microwave Drying
Pumps (Centrifugal and Diaphragm)
Capsule Machines
Compactors
Solution Preparation Systems And Tanks
Granulators/ Dust Collector
Vertical Manufacturing Trains
Auto Test 4 Pharmatron Tablet Tester (AT4)
Metal Detectors
CIP And WIP Systems
IV Packaging:
Equipment, Computer, Cleaning and Process Validations
Unscramblers
Fillers
Cappers
Labelers
Batch/Date/Bar Coders
Blister Packers
Accumulation Tablets
Cartonners
Wrappers
Sealers
Palletizers
Cottonners
Retorquers
Casepackers
Conveyors
Controls and Indicators
V Utilities:
Equipment, Computer and Process Validations
HVAC Systems
Clean Steams
Plant Steams
Purified Water
Chiller Water Systems
Jacket Vessels
Heat Exchangers
Vacuum
Emergency Power
Water for Injection
Sterile Air
Compressed Air
Plant Air
Air and Water Quality Monitoring
Nitrogen
Dust Collection
VI Facilities:
Equipment, Computer, Cleaning and Process Validation
Compounding / Formulation
Aseptic Suites
Laboratories
Controlled Substances
Environmental Rooms
Containment Areas
Medical Devices
Barrier Technology
VII Bulk Pharmaceuticals:
Equipment, Computer and Process Validation
Reactors
Solvent Recovery
Distillation Columns
Crystallizers
Extruders
Filtration
Drying
Holding Tanks
Tank Farms
Vessels / Agitators
VIII - Computer System Validation:
Equipment, Computer, Cleaning and Process Validations
Computer Validation and Audit Trail
Data Security and Integrity
CAPAs Plans
Retention of Electronics Records
Modification of Legacy Systems
Passwords, ID Codes an signatures
Problems Areas Like:
Database Queries
Handwrite FDA
Media Access
Hybrid Systems
Our Services Include:
Lab Furniture Installation Division:
PCC offers professional, factory-trained installers with comprehensive knowledge of furniture components and extensive experience to assure fast, trouble-free installations.
Our Clients:
Clients (Validation Services)
Abbott Fermentation Products
Abbott Laboratory
Abbott Diagnostic
Bristol Myers-Squibb
Bio Vail
VWR International
Cardinal Health Plans
Johnson & Johnson Pharmaceuticals Partners
Lilly Del Caribe
Jacobs
Watson Laboratories
Wyeth Guayama
Wyeth Carolina
I VAX CIDRA
ST. CROIX
Tyco Healthcare ( USSC ) - Ponce
Clients (Installation Services)
Schering Plough Manati
Schering Plough Las Piedras
Baxter Jayuya
Bristol Barceloneta
Abbott Jayuya
Boston scientific Miami
Baxter Maricao
Bristol Mayaguez
Baxter Maricao
Bristol Manati
Colegio Marista
Hewlett Packard
ICN Humacao
I Vax
Janssen
Watson
Lilly Mayaguez
Mc Neil
Ortho
Schering Plough
UPR Ponce
UPR Mayaguez
Johnson & Johnson
University Puerto Rico Mayaguez, Rio Piedras, Cayey
ON SITE PROJECT MANAGEMENT SERVICES
Pharma Consulting Corp. (PCC) can supply client project management needs by providing on site resources. Our experienced project management group can provide the following services:
Overall project supervision
Project scheduling
Cost control
Technical coordination and inspection
Subcontractors work supervision and coordina Read more
Categoria
- Laboratorio farmaceutico
- Attrezzatura farmaceutica
- Stanze sterili
- Personale farmaceutico
- Consulenti farmaceutici