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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.
0101
OUR SERVICES
Calibration & Validation
Cleanroom / HVAC Validation
Computer System Validation
Training and Education
Pharmacovigilance and Regulatory Compliance
Cold Chain Solutions and Validation
02
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
03
Valical enables users to Design, Implement and Maintain a cost-effective calibration quality system to reduce compliance risk.
04
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.
04
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
05
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.
06
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
07
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
08
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
09
10
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
11
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.
12
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
13
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
14
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