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Valical is an ISO 9001:2015 certified full validation service provider

that strives to maintain and inspire professional excellence by

providing validation & calibration services to Pharmaceuticals,

Bio-pharma, Biologics, Medical Services, Healthcare and Food

Industries.

We have the Experience, Expertise and Commitment to provide the

superior service required to meet all of International Regulatory

Compliance needs.

We offer a full spectrum of services such as Calibration & Validation,

Clean room certification, Temperature mapping, Cold chain monitoring,

Indoor Air quality monitoring, Process equipments and Facility

qualification.

The foundations of Valical are : Dedicated to quality, Personalized

local support and Strong integrity practices.

Our values guide all of Our Actions, Decisions and Behaviours.

We have highly diverse cultural backgrounds with different experiences

operating in broad range of markets and industries.

Our values are shared, understood and lived by everyone at Valical

and are important for our future success.

INTEGRITY

PASSION

ACCOUNTABILITY

SUSTAINABILITY

We are honest, open, ethical and fair. People trust us to adhere to our actions.

Committed in heart and mind.

Delivering the best in all we do, holding ourselves accountable for results.

We believe in sustainable growth and protecting mother nature.

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OUR SERVICES

Calibration & Validation

Cleanroom / HVAC Validation

Computer System Validation

Training and Education

Pharmacovigilance and Regulatory Compliance

Cold Chain Solutions and Validation

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Calibration helps in quantifying and controlling errors and uncertainties within various

measurement processes to an acceptable level. It helps in improving the accuracy of the

measuring device which enhances the quality of the end product making sure that the

readings of equipment or instruments are consistent with other measurements and display the

correct readings every single time.

A calibration has to pass the ISO 9000 or ISO 17025 standards in order to be considered

internationally acceptable. It would include formal, periodic and even documented calibration

so that proper quality management of these devices can take place.

Calibration can easily be performed on a new device or instrument. However, when an instrument

is damaged or modified it needs new calibrations as well. When instruments are being used for

specific purposes like measuring a set range of temperature for a certain period of time, it can be

calibrated differently as well. The accuracy is always defined when calibrating an instrument. Most

of the instruments have to go through strict benchmarks in terms of performance but only a few of

them deliver up to those standards. Calibration plays an important part in deciding this.

CALIBRATION

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Valical enables users to Design, Implement and Maintain a cost-effective calibration quality system to reduce compliance risk.

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We offer calibration services for most pressure and flow instruments :

Temperature and Humidity Instruments

Torque and Force Instruments

Electronic Instruments

Pressure Equipments

Dimensional instruments using test equipments traceable to National Institute of Standards

and Technology (NIST).

The instruments are processed in accordance with ISO/IEC 17025:2005 standard. The Certificate

of Calibration includes as found and as left data with uncertainties, tolerance and assessment of

compliance with the manufacturer's specifications.

Valical follows ISO 17025 standard to ensure uniform calibration practices for its clients. The

calibration services include establishment of calibration intervals and maintenance of

calibration data files using the latest calibration software database package.

Valical provides a full range of on-site calibration service to meet GMP or GDP standards and seek to

minimize any downtime associated with annual calibration requirements.

The calibration is conducted to high accuracy and standards to meet any quality system. It is fully

traceable to NATA standards. Certificates and Reports are issued to complete any validation or

qualification requirements.

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In Pharma Industry, it is very important apart from final testing and compliance of product

with standard that the process adopted consistently produces the expected results.

Qualification of systems and equipments are a part of validation and is a requirement of

pharmaceutical regulating agencies like FDA's GMP (Good Manufacturing Practice)

FDA or any other food and drug regulatory agency require processes, procedures, intermediate

stages of inspections and testing adopted during manufacturing and are designed such that

when adopted they produce consistently similar, reproducible, desired results which meet the

quality standard of product being manufactured. Such procedures are developed through the

process of validation. This is to maintain and assure a higher degree quality of food and drug

products. A properly designed system will provide a high degree of assurance that every step,

process, and change has been properly evaluated before its implementation.

The Validation Master Plan outlines the principles involved in the qualification of a facility, defines

the areas and systems to be validated and provides a written program for achieving and

maintaining a qualified facility with validated processes. It is the foundation of the validation

program and should include process validation, facility and utility qualification and validation,

equipment qualification, cleaning and computer validation.

VALIDATION

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Valical ensures support to clients in developing, implementing and achieving a validation strategy and programme designed to meet customer's timescales and budget fully satisfying cGMP requirements and regulatory obligations of licensing bodies.

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We deliver optimized validation for each client to ensure the organisation complies with necessary

FDA and HACCP standards.

We help clients develop a validation plan, design important qualification protocols, standard

operating procedures and audit installations for compliance. We provide facilities, HVAC system,

equipment, cleaning, process, computer system (21 CFR Part 11) and cold chain validation.

Our services are based on classic V-model and include trained validation consultants

to assist with any or all of the following activities:

Project Management

Risk Analysis

Validation Planning / Validation master plan

Software Validation

IQ/OQ/PQ Protocol Development

Test script authoring like execution, templates, creation of validation summary report, SOP

development, Regulatory compliance assessments, change control and validation training.

Whether you are subjected to :

Regulatory body audits such as (Schedule M)

WHO (Geneva)

TGA, USFDA, MHRA, MCC, ENVISA

Comply with GMP, cGMP, GAMP 5, 21 CFR Part 11 and EU Annex 11 requirements for achieving

right level of validation and traceability to National and International Standards.

CLEANROOM/HVAC

VALIDATION

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Valical offers a comprehensive range of Cleanroom/HVAC Validation services for Clean room

facilities for Pharmceutical, Healthcare, Medical devices and Biologics facilities in line with

cGMP and ISO standards.

Valical Performs the Cleanroom/HVAC Validation as per ISO 14644-1/2/3, EU GMP, MHRA,

WHO TRS 937, WHO TRS 961 and Schedule.

The Validation Services Include:

Air Velocity Measurement

Non Viable Particle Count Test

DOP/PAO Hepa Filter Integrity Test

Room Pressurization Test

Airflow Visualization Test

Recovery Time Studies

ACPH Calculations

Temperature and RH Measurement

Air Pressure balancing , Testing and Adjusting

Light Intensity and Sound Level Measurement

TRAINING,LEARNING

ANDDEVELOPMENT

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Valical can provide the adequate support by performing on site group trainings.

The content can be adjusted to your needs together with course material and assessment as

required by GxPs.

Valical’s team consultants have expertise in quality throughout the pharma business and other

lifescience area covering many fields of quality including GMPs, GDP, GCP and GLPs.

To ensure the effectiveness of our training modules, it is tied to specific results & deliverables that

are agreed upon with customer.

We provide a wide range of training services which are fully customized for client technical needs

and financial capabilities.

GMP Training at Different Levels (general, in detail for different areas of the plant)

Training in Quality Systems

Specific Training in the Area of Quality Assurance, Production Control and Production

Specific Training in the Development Area (analytical development, pharmaceutics and

clinical registration)

Specific Training in Sterile Environments (personal, environmental controls, lab, isolators….)

GMP Specific Training Required (risk analysis, preparation of audits of any regulatory

agency)

Corporate Training Deals

Development of Training Systems

Assessment of Existing Training

Systems and Plans for Improvement

COMPUTER SYSTEM

VALIDATION

At Valical we employ a risk based approach to the computer system Validation (CSV) process

ensuring the right amount of testing and documentation is undertaken. This approach to CSV

saves our client considerable time and money when implementing electronic systems. We have

a dedicated team of validation and compliance experts who develop and implement system

validation activities based on industry best practices and their significant industry knowledge.

Our knowledge of life sciences software and systems is extensive and can be leveraged in your

next review/implementation project.

Performance validation can help you to achieve FDA compliance for a wide range of computer

system types including ERP, LIMS, LIS, EDC, eQMS, laboratory instrumentation and other

business information systems. We also have extensive capability with SCADA, PLC and MES

(Manufacturing Execution System) validation with decades of experience in Computerised

system validation, performance validation is positioned to deliver right sized and integrated

solution.

Our Services Include:

21 CFR Part 11 and Annex 11 Regulatory Impact Assessment GAMP5 Software Life cycle development PIC/S annex 11 on Validated Computer System Audit Preparation and Readiness Service Comprehensive Validation Strategy

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Practically speaking the FDA part 11 regulations require drug makers, medical device manufacturers,

biotech companies, biologics developers etc to implement controls including audits, system

validations, audit trails, electronic signatures and documentation for software and systems involved

in processing electronic data. The data is specifically required to be maintained by FDA.

We deploy our services through global delivery centers in India, USA, UK and UAE. Our ability to

provide support through on shore, off shore and hybrid models enables us to offer a predictable

costing model across time zones. Companies that need to scale up to meet short term requirements

during audit preparedness, validation of new systems or data migration can be utilize our on

demand services augmented by a small team for the project duration.

Computer System Validation Deliverables

Validation Plan

System Impact Assessment

Requirements Specifications (URS,PRS,FS/TS)

System Configuration Specifications

Test Plan

Installation Qualification (IQ) Testing & Reports

Operational Qualification (OQ) Testing & Reports

Performance Qualification (PQ) Testing &Reports

Traceability Matrix

Quality Assurance Review

Validation Summary Report

Draft Review of Standard Operating Procedure (SOP)

GMP /GDP Training

Our experienced consultants have real world experience in laboratory preclinical, clinical, dug safety and regulatory areas, plus a powerful set of CSV templates, processes and procedure tools and reusable assets to reduce your CSV timeline

Pharmacovigilance is a pharmacological science that helps us to better evaluate the undesired

effects of drugs, report them to the applicable authorities and thus help in ensuring that only safe

drugs stay in the market.

Our Pharmacovigilance professionals are qualified drug safety specialists who provide

product/drug safety data and documentation. One particular area of their work includes

performing a lot of functional responsibilities like Safety Trend Analysis, Maintaining Adverse

Reaction Data, Keeping Global Safety Databases updated and conducting Safety Training.

Xendo Pharmacovigilance is a flexible service provider that gives access to a wide range of

services with a senior expert team repeatedly highlighting as an essential criterion.

Working on a global level, we understand international requirements by consistently being

quality driven and customer focused that has led to a proven track record of meeting or

exceeding client's expectations. We are also regularly asked to lecture or moderate at

international seminars and symposia as experts in the field.

We are a full-service provider for Pharmacovigilance due to sound quality management systems.

All activities conducted for and on behalf of clients are ensured to be in line with applicable

standards.

PHARMA-COVIGILANCE

AND REGULATORY COMPLIANCE

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Pharmacovigilance

Regulatory Compliance

In the pharmaceutical industry, Regulatory Compliance not only plays a crucial role in the overall drug development process but also after the drug is approved and marketed.

Regulatory compliance specialists are expected to be extremely passionate regarding the safety and efficiency of drugs and medical devices in the healthcare industry. Their interest for the sector must be deeply grounded into their function. This role demands expertise in a few distinct areas to be able to become successful.

Valical helps to navigate scientific and regulatory requirements and provide high level regulatory affairs services in all phases of product life cycle, from early stage development to marketing authorization and post approval requirements.

Our specialists have a wide understanding of legal, scientific and business concerns in order to perform their work effectively. They ensure that products are developed within the legal framework and as per recommended guidelines.

We provide a complete range of services needed for successful preparation, submission and support of pharmaceutical, bio-pharmaceutical and medical device dossiers.

The strengths of our department :

Flexibility

Experience in multidisciplinary projects.

Excellent relations with health authorities.

Deep knowledge of Legislation and

Regulatory environment.

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Quality, Safety and Risk management are crucial concerns within the pharmaceutical industry.

Valical provides Regulatory compliance and Quality solutions that guide projects from the design stage to full implementation and ongoing support.

Our Partner

GxP Audit services.

QMS Remediation services.

Supplier audits / Vendor assurance.

Laboratory systems (GLP).

Our Services :

Cold chains are universally used in the food, pharmaceutical and some chemical shipments. The

cold chain is a logistical system which manages temperature often between 2° to 8° celsius. It is a

series of distribution activities which continuously maintain this temperature in order to protect

the temperature-sensitive cargo from manufacture to the point of consumption.

Cold chain requires to additionally maintain product specific environment parameters which

include air quality levels (carbon dioxide, oxygen, humidity and others) that makes it the most

complicated cold chain to operate.

COLD CHAINSOLUTIONS

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At Valical, we offer both active as well as passive cold chain solutions considering the regulatory

standards as specified. We understand that accurate and consistent cold chain temperature

performance is critical for the business. Hence, we design, develop and offer products with the

latest tools and temperature mapping calibration capabilities to perform temperature mapping

validation with industry leading expertise.

End-to-End Solutions Steadfast Protection Intelligent Logistics

Real Time Monitoring Regulatory Compliance Risk Mitigation

Why Choose Valical?

At Valical, we offer end-to-end traceability for cold chain products using real-time temperature compliance with advanced technology platform.

Our highly qualified validation technicians are prepared with the latest tools and temperature

mapping calibration capabilities to perform temperature mapping validations with industry leading

expertise.

Our range of intelligent environmental monitoring products provide customers with the tools to

maintain stable conditions and stay compliant throughout the cold chain.

Our Services include :

Cold Chain Consulting

Cold Chain Qualification and Testing

Cold Chain Temperature Monitoring

Cold chain Packaging

Data Loggers / Temperature Recorders

Calibration and Packaging Testing

We comply with following Regulations and Directives:

USP chapter IO79: Good storage and shipping practices.

EU GDP Regulation (2013 / C343 / OI)

WHO model requirements for storage and transport of time and temperature sensitive

pharmaceutical products.

ISPE Guidelines on cold chain

PDA Technical Report No.39 guidance for temperature medicinal plants.

ICH Guidelines

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Corporate OfficeMUMBAI

C/701, Satellite Garden, Film city Road, Goregaon, Mumbai (E) - 400063

Registered OfficeMUMBAI

B4/201 Lok Nisarg, Mulund, Mumbai (W) - 400080

+91-9820795546

www.valical.com

info@valical.com