www.tjmphosconsultants.com

Validation ConsultingEquipment Qualification| Process Validation | Computer System Validation|Cleaning Validation | Analytical Method ValidationTJM Phos Consultants possess extensive knowledge in various pharmaceutical manufacturing processes, computerized automated control systems, computer systems, laboratory instrumentation & information systems, and manufacturing equipment, packaging equipment, gap assessments and remediation programs.

Our services include but not limited to:

Equipment QualificationWe provide the technical expertise to conform to all user requirements, design specifications, and regulatory requirements in the fields of Manufacturing Equipment, Packaging Equipment and Analytical Laboratory Equipment.

Process ValidationProcesses could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated Pharmaceutical, biopharmaceutical, API and Medical Device industries. Manufacturing Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including Aseptic Processing Validation, Environmental Baselines, Liquids (sterile/non-sterile), Ointments, Product Validation, Suspensions, Capsules and Tablets.

Computer System ValidationComputer System Validation (CSV) means establishing documented evidence that provides a high degree of assurance that a specific computerized system will consistently operate in accordance with pre-determined specifications. Computer-related system requirements document is the foundation for the computerized system validation. A successful validation project depends upon proper definition of the system. We can create the following documents and execute the validation protocols for your system.

• User Requirements Specification (URS) • Validation Change Control• Project Validation Plan • Functional Specification (FS) • Design Specification (DS) • Installation Qualification (IQ) • Operational Qualification (OQ)

• Performance Qualification (PQ) • Functional Requirement Assessment (FRA)• Failure Modes Effects Analysis (FMEA) • Data Migration (if any) • Reports

Cleaning ValidationThe prevention of cross contamination is an essential component of any GMP program and is necessary to ensure the safety of drugs, biologics and medical devices used in human or veterinary applications. We determine the cleaning processes for each piece of equipment.

Analytical Method ValidationAnalytical Method Validation is defined as the process of providing (thorough Scientific Studies) that an Analytical Method is acceptable for its intended use. Analytical Methods Development and Validation play important roles in the discovery, development and manufacturing of pharmaceuticals. The official test methods that result from these processes are used by QC lab to ensure the identity, purity, potency and performance of drug products.

Commissioning & Qualification (C&Q)We provide an efficient, effective documented program that follows and complies with global regulations and guidelines. Our engineering project life cycle experience ensures that commissioning and qualification issues impacting on the design phase of a project are fully considered and integrated at the start of a project. We can provide consistent guidance for design, construction, and commissioning and qualification of manufacturing facilities and utilities. Our qualification efforts will help with sound and responsible interpretation of regulations which govern manufacturing operations based on international standards.

We can perform C&Q for the following areas but not limited to:

• Facility and Utility

• Manufacturing Equipment with Control System

• Packaging Lines and Equipment with Computerized Systems

No. 16/1, Ground Floor, AVS Compound, 80 ft Road, 4th Block, Koramangala, Bangalore - 560034. +91-80-6566-0080

tnc@tjmphosconsultants.com +91-9901666102

TJM PHOS CONSULTANTS LLP

justin@tjmphosconsultants.com +91-9945766377

TJM PHOS CONSULTANTS LLP

Consulting with trust, integrity & solidity

Nurturing consulting relationships through bonds built on trust and integrity.

TJM PHOS Consultants is based in Bangalore, India is a premier, professional validation consultancy providing a full scope of regulatory services and products across the globe for Pharmaceutical, Biopharmaceutical and Medical Device companies. TJM PHOS offers a diverse set of expert consulting deliverables in the core areas of Compliance such as Quality Systems, Regulatory Audits, GMP Trainings, Equipment Qualification, Computer Systems Validation, Cleaning Validation and Analytical Method Validation. Our other area of expertise is Commissioning & Qualification (C&Q) and Project Management for startup companies.

We partner with major US Pharma Consultant Companies to meet your needs in regulatory compliance for Pharmaceutical, Biopharmaceutical and Medical Devices which will help you to be in compliance with international regulatory agencies.

Services and Solutions which include but not limited to:

• PLC /SCADA / Vision System Validation

Offering top quality, expertise driven regulatory consultancy services, across the globe.TJM PHOS Consultants offer GMP, Validation and Regulatory Compliance Solutions for companies seeking to obtain a competitive advantage and compliance towards various areas of GMP. Our approach to current Good Manufacturing Practice (cGMP) is very concise and provides quality documents to your staff and then makes sure that it is followed and the results are documented.

Turn-key project management and Start-up support services.

We have GMP consultants to work at your site under your direction on short notice for short or long duration projects. These include: Pharmaceutical Engineers, GMP Compliance Consultants, Validation Consultants, Project Management Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice to handle Turn-key Project Management and Start-Up Support Services.

We implement GLP and GMP Quality Management Systems, perform GMP audits and offer practical recommendations and remediation work for closing the identified gaps. Our GMP consultancy also offers GMP Training for the Pharmaceutical, Biopharmaceutical, Medical Device Life Science industries, including basic GMP training, GAMP 5 training, ISO 13485 training and Q9 / ISO 14971 Quality Risk Management training courses.

Our Validation consulting services include C & Q for Facility & Utility, Manufacturing and packaging Equipment Qualification, Cleaning Validation, Process Validation, Analytical Method Validation and Computer Systems Validation for Pharmaceutical, Biopharmaceutical and Medical Device companies based on PIC/S, ANVISA, EMEA, Health Canada, FDA and TGA Regulations.

Our Expert staffs have many years of industrial experience and held key positions in start-up and fortune five hundred companies. Their expertise in dealing with foreign regulatory agencies will provide excellent benefit for the projects TJM PHOS Consultants undertake.

We have many experienced Computer Systems Validation consultants within our GMP consultancy who can advise on various Computer Systems used in GMP environment, Equipment Control System Validation, FDA 21 CFR Part 11 and Annex 11 regulations.

Compliance ConsultingQuality Systems | Regulatory Audits | GMP Trainings

Current Good Manufacturing Practice (cGMP) regulations require all manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

Quality systemsManufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. Quality Risk Management is integral to an effective pharmaceutical quality system. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle.

TJM PHOS has expertise in the areas of Site Master Validation Plans, Periodic Reviews, Change Control, Procedures, Policies and Guidelines, CAPA, Calibration, PM Procedures and GAP Analysis / Risk Assessments.

Regulatory AuditsWe help to design audit and corrective action plans to accommodate your needs, including MHRA, EMEA, ANVISA, Health Canada and FDA regulations by offering services related to Internal Audits, Pre-approval Inspections, Contract Manufacturing GMP Audits, API Manufacturer Audits and IT Systems Audits.

GMP TrainingWe provide cGMP training programs to fit for your needs from cGMP orientation for new hires through annual cGMP Training on various cGMP Modules. Our new hire cGMP orientation is an overview of basic GMP concepts and emphasizes, to new employees, the importance of understanding and following governing regulations. This will give them a good background to promote regulatory compliance when they receive On-the-Job Training (OJT).

Regulatory consulting services customized for your specific project needs.

• Manufacturing Equipment Qualification with Control System Validation.

• Computerized System Validation such as MODA, BMS, EtQ, TrackWise, Serialization Track and Trace, QIS, QMS, FreeWeigh.Net, Empower3, and LIMS

• Laboratory Equipment Qualification and Software Validation

• Compliance oriented Validation Solutions

• Compliance Audits, recommendations and remediation services

• Facility design, construction, or operation from a compliance perspective

• Harmonized compliance efforts across diverse business software systems

• Result oriented, client-tailored approach in compliance with both domestic and international regulatory bodies

• Project Management Services for new and existing projects