& Associates
Client Services
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isolators
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Client Services
Agalloco & Associates is a New Jersey corporation led by James Agalloco, an internationally recognized expert on pharmaceutical technology, aseptic processing and process/system validation. A&A provides a wide range of technical services to the pharmaceutical and biotechnology industries. Our experience base includes all types of pharmaceutical dosage forms, medical devices, bulk pharmaceutical chemicals and biologicals. A&A has particular expertise in the areas of validation, aseptic processing, sterilization, sterile bulk preparation, isolation technology, computer systems validation, quality assurance, and facility design. A&A draws upon a network of highly qualified individuals and organizations for the execution of larger tasks.
A&A's expertise can assist you with:
- Aseptic Processing
- Biologics
- Bulk Pharmaceutical Chemicals
- Computerized Systems
- Isolator Technology
- Manufacturing
- Medical Devices & Diagnostics
- Oral & Solid Dosage Forms
- Processing Equipment
- Regulatory Affairs & Compliance
- Research & Development
- Sterilization
- Training
- Validation
Aseptic Processing
Review of current and future technology; evaluation of contract facilities;
review of parenteral technology and regulatory compliance; in-house training
of professional staff; evaluation of facility design concepts; development
of environmental monitoring program; review of classified environment
design proposal; facility modification and reopening; conversion of aseptic
fills to terminal sterilization; assistance inregulatory compliance
Biologics
Assist in biological drug pre-approval inspection preparation; trouble
shoot bioreactor contamination problem; conceptual design of isolator
facility for fermentation / purification / formulation/ filling; conceptual
design review for facilities; application of isolation technology; review
of facility and utility systems; definition of cleaning validation program;
review of validation requirements for CGMP operations; development of
environmental monitoring program; review of vaccine facility design and
construction details; validation of aseptic processing; qualification
of laboratory equipment
Bulk Pharmaceutical Chemicals
Review of BPC validation requirements; validation of process control systems;
review of design specification for distributed control system; definition
of cleaning validation program; assistance in facility qualification /
validation; validation master planning; assistance in aseptic processing
and sterilization-in-place for sterile bulk operations; project manager
for validation of BPC facility; review of Drug Master Files; conceptual
development of facility renovation for sterile bulk operations; design
review for sterile bulk manufacturing facility
Computerized Systems
Review of facility and system design concepts for automated tablet facility;
definition of computerized systems validation requirements; audit process
control & equipment system development; review of lyophilizer control
system validation; qualification / validation of process control system;
validation master planning; change control and change management procedures
Isolation Technology
In-house training programs; assistance with liquid fill isolator qualification
/ validation; isolator based sterility test system validation; application
of isolation technology concepts for clinical production; conceptual design
of isolation technology based filling system; design concepts for integration
of isolation technology to solid dosage formulation; validation master
plan for cytotoxic parenteral facility; design and validation of microbial
sampling system; application of isolation technology to medical device
production
Manufacturing
SOP and validation audits; facility design reviews; sterile powder manufacturing
technology; facility conversion from cephlasporin production; facility
and equipment design review; qualification / validation of parenteral
facilities; preparation and review of standard operating procedures
Medical Devices & Diagnostics
Conceptual review of facility design; conduct custom validation training
program; validation of controlled environments; validation of aseptic
processing; design of environmental monitoring program; isolator based
sterility test system validation; qualification / validation of medical
device intermediates; application of isolation technology; review of cleaning
validation program; assistance with cleanroom classification and operation;
review of process validation program
Oral & Solid Dosage Forms
Review of facility design concepts; development of cleaning validation
program; cost estimate for oral products facility; review of standard
operating procedures; evaluation of contract manufacturing site; assistance
in manufacturing process development; validation support for non-sterile
products facility start-up; validation protocols and reports for tablet
products
Processing Equipment
Design and validation of sterilizer control systems; conceptual and detailed
design of novel sterilization system; development of equipment manuals
and qualification documentation; design of isolators for various applications;
development of factory acceptance test protocols
Regulatory Affairs & Compliance
Assistance in regulatory interaction; assistance with FD483 response;
assistance with regulatory letters; assistance with regulatory interface;
NDA submission preparation assistance; assistance with international regulatory
compliance
Research & Development
Preparation of process development reports for oral products; cleaning
validation master plan for clinical operations; review of parenteral formulation
design; review of operating procedures and test methods; audit and review
for pre-PAI assessment; pre-approval inspection preparation; assistance
in scale-up/validation of lyophilized formulation; design and implementation
of isolator based manufacturing system; development of qualification protocols
for analytical laboratory equipment
Sterilization
Development and validation of sterilization processes; validation of sterilization-in-place
procedures; sterilization science training program; review of terminal
sterilization validation program; validation of terminal sterilization;
conceptual design of CIP/SIP systems; sterilization process trouble shooting;
validation of radiation sterilization
Training
Aseptic Processing; Isolation Technology; Sterilization-In-Place; Master
Planning; Plant and Process Validation; Clean-in-Place; Sterilization
Processes; participate in corporate training programs; custom courses
developed upon request
Validation
Validation master plan preparation and review; development of validation
master summary; review & refinement of corporate validation programs;
preparation of validation protocols and reports; process and system validation;
review of validation programs; systems and documentation; develop WFI
and DI water system validation program; audit of critical utility system
validations; design of retrospective validation program; review of CMC
sterilization section