Webinar validation of pharmaceutical manufacturing processesDr. Ganesh Prasad
This is a one hour presentation on the recent concepts of pharmaceutical manufacturing process validation in line with the 2011 FDA and EMA guidelines.
Webinar validation of pharmaceutical manufacturing processesDr. Ganesh Prasad
This is a one hour presentation on the recent concepts of pharmaceutical manufacturing process validation in line with the 2011 FDA and EMA guidelines.
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
This Presentation provide the understanding about importance of following standards and comply with regulatory requirements. This PPT Prepared to provide Awareness Training on Quality Management System as per ISO 17025:2017 with case studies and Questionnaires
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Xcelience is a contract research organization that has provided formulation development and clinical trial manufacturing solutions for pharmaceutical companies since 1997. The company is renowned for reliably expediting early development activities to speed potential drugs to clinical trials while applying stage-specific scientific knowledge and experience. Core services include: API Characterization, Analytical Development and Stability Services, Formulation Development, and Clinical Trial Manufacturing, Packaging and Labeling. For more detailed information about Xcelience, visit www.xcelience.com
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
This Presentation provide the understanding about importance of following standards and comply with regulatory requirements. This PPT Prepared to provide Awareness Training on Quality Management System as per ISO 17025:2017 with case studies and Questionnaires
Laxmi Genchem Sciences Pvt Ltd is contract research & generic API manufacturing organization that services global pharma industry; is operated in Hyderabad, INDIA. Established in 2013, has a rich experience in a focused business to rapidly assist our partners in development of NCEs & Generic API non-fringing route scouting; will support the commercial manufacturing with all global regulatory requirements;A Global company in its aspiration with a focus on all stake holders, the employees, the customers and finally the consumers of the products (finished dosages) that carry our quality Ingredients.
Creating knowledge, building strong intellectual base, cultivating an environment with values such as respect, diligence and strong sense of creativity shall be our hallmarks.
Visit us:
www.laxmigenchem.com
Master of Good Manufacturing Practice - Course Detailsutspharmacy
Staff who hold postgraduate degrees in Good Manufacturing Practice (GMP) are essential for many pharmaceutical, biologic, medical device and food manufacturing companies.
This presentation provides an overview of the Master of Good Manufacturing Practice offered at the University of Technology, Sydney (UTS) in Australia. For more information visit www.gmp.uts.edu.au
Commrcialization is the process of bringing new product to services to market . The broader act of commercializ
Commercialization is the process of bringing new product to services to market. The broader act of commercialization entails production, distribution, marketing, sales, customer support, and other key function critical to achieving the commercial success of the new product or service.
PAT and QbD concepts in designing the LiMS and other Electronic systems in La...balakrishna t
tQmlab® is the premier management system for GxP operations and for supporting regulatory submissions. It delivers transformational productivity for QA/QC labs supporting customised workflows for quality control of drugs, stability testing, product release testing and post-release quality testing.
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
Ian brings 16 years of experience in the Biotech/Pharmaceutical Industry in Quality Assurance and Quality Control. He has extensive knowledge of all of the applicable regulatory requirements.
My last projects as an independent contractor were with SHIRE, LONZA and NOVARTIS. I conducted Product Investigations from Inoculations of Media to Manufacturing projects which included from line clearance issues to inclusions of foreign material. Also, Inspection of all product packaging to determine a non-negative product impact.
DevOps and Testing slides at DASA ConnectKari Kakkonen
My and Rik Marselis slides at 30.5.2024 DASA Connect conference. We discuss about what is testing, then what is agile testing and finally what is Testing in DevOps. Finally we had lovely workshop with the participants trying to find out different ways to think about quality and testing in different parts of the DevOps infinity loop.
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
LF Energy Webinar: Electrical Grid Modelling and Simulation Through PowSyBl -...DanBrown980551
Do you want to learn how to model and simulate an electrical network from scratch in under an hour?
Then welcome to this PowSyBl workshop, hosted by Rte, the French Transmission System Operator (TSO)!
During the webinar, you will discover the PowSyBl ecosystem as well as handle and study an electrical network through an interactive Python notebook.
PowSyBl is an open source project hosted by LF Energy, which offers a comprehensive set of features for electrical grid modelling and simulation. Among other advanced features, PowSyBl provides:
- A fully editable and extendable library for grid component modelling;
- Visualization tools to display your network;
- Grid simulation tools, such as power flows, security analyses (with or without remedial actions) and sensitivity analyses;
The framework is mostly written in Java, with a Python binding so that Python developers can access PowSyBl functionalities as well.
What you will learn during the webinar:
- For beginners: discover PowSyBl's functionalities through a quick general presentation and the notebook, without needing any expert coding skills;
- For advanced developers: master the skills to efficiently apply PowSyBl functionalities to your real-world scenarios.
Dev Dives: Train smarter, not harder – active learning and UiPath LLMs for do...UiPathCommunity
💥 Speed, accuracy, and scaling – discover the superpowers of GenAI in action with UiPath Document Understanding and Communications Mining™:
See how to accelerate model training and optimize model performance with active learning
Learn about the latest enhancements to out-of-the-box document processing – with little to no training required
Get an exclusive demo of the new family of UiPath LLMs – GenAI models specialized for processing different types of documents and messages
This is a hands-on session specifically designed for automation developers and AI enthusiasts seeking to enhance their knowledge in leveraging the latest intelligent document processing capabilities offered by UiPath.
Speakers:
👨🏫 Andras Palfi, Senior Product Manager, UiPath
👩🏫 Lenka Dulovicova, Product Program Manager, UiPath
Accelerate your Kubernetes clusters with Varnish CachingThijs Feryn
A presentation about the usage and availability of Varnish on Kubernetes. This talk explores the capabilities of Varnish caching and shows how to use the Varnish Helm chart to deploy it to Kubernetes.
This presentation was delivered at K8SUG Singapore. See https://feryn.eu/presentations/accelerate-your-kubernetes-clusters-with-varnish-caching-k8sug-singapore-28-2024 for more details.
State of ICS and IoT Cyber Threat Landscape Report 2024 previewPrayukth K V
The IoT and OT threat landscape report has been prepared by the Threat Research Team at Sectrio using data from Sectrio, cyber threat intelligence farming facilities spread across over 85 cities around the world. In addition, Sectrio also runs AI-based advanced threat and payload engagement facilities that serve as sinks to attract and engage sophisticated threat actors, and newer malware including new variants and latent threats that are at an earlier stage of development.
The latest edition of the OT/ICS and IoT security Threat Landscape Report 2024 also covers:
State of global ICS asset and network exposure
Sectoral targets and attacks as well as the cost of ransom
Global APT activity, AI usage, actor and tactic profiles, and implications
Rise in volumes of AI-powered cyberattacks
Major cyber events in 2024
Malware and malicious payload trends
Cyberattack types and targets
Vulnerability exploit attempts on CVEs
Attacks on counties – USA
Expansion of bot farms – how, where, and why
In-depth analysis of the cyber threat landscape across North America, South America, Europe, APAC, and the Middle East
Why are attacks on smart factories rising?
Cyber risk predictions
Axis of attacks – Europe
Systemic attacks in the Middle East
Download the full report from here:
https://sectrio.com/resources/ot-threat-landscape-reports/sectrio-releases-ot-ics-and-iot-security-threat-landscape-report-2024/
Key Trends Shaping the Future of Infrastructure.pdfCheryl Hung
Keynote at DIGIT West Expo, Glasgow on 29 May 2024.
Cheryl Hung, ochery.com
Sr Director, Infrastructure Ecosystem, Arm.
The key trends across hardware, cloud and open-source; exploring how these areas are likely to mature and develop over the short and long-term, and then considering how organisations can position themselves to adapt and thrive.
UiPath Test Automation using UiPath Test Suite series, part 4DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 4. In this session, we will cover Test Manager overview along with SAP heatmap.
The UiPath Test Manager overview with SAP heatmap webinar offers a concise yet comprehensive exploration of the role of a Test Manager within SAP environments, coupled with the utilization of heatmaps for effective testing strategies.
Participants will gain insights into the responsibilities, challenges, and best practices associated with test management in SAP projects. Additionally, the webinar delves into the significance of heatmaps as a visual aid for identifying testing priorities, areas of risk, and resource allocation within SAP landscapes. Through this session, attendees can expect to enhance their understanding of test management principles while learning practical approaches to optimize testing processes in SAP environments using heatmap visualization techniques
What will you get from this session?
1. Insights into SAP testing best practices
2. Heatmap utilization for testing
3. Optimization of testing processes
4. Demo
Topics covered:
Execution from the test manager
Orchestrator execution result
Defect reporting
SAP heatmap example with demo
Speaker:
Deepak Rai, Automation Practice Lead, Boundaryless Group and UiPath MVP
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
The Art of the Pitch: WordPress Relationships and SalesLaura Byrne
Clients don’t know what they don’t know. What web solutions are right for them? How does WordPress come into the picture? How do you make sure you understand scope and timeline? What do you do if sometime changes?
All these questions and more will be explored as we talk about matching clients’ needs with what your agency offers without pulling teeth or pulling your hair out. Practical tips, and strategies for successful relationship building that leads to closing the deal.
2. Overview
●
Located in Bangalore, a Dedicated cGMP and cGLP Compliance
Laboratory
●
●
●
Established in September 2010
●
●
Registered with USFDA for Old Facility and under process for New Facility
●
In the business of Formulation R&D, Analytical Development, Validation &
Stability Management Programs.
Approved Drugs & Pharmaceutical Facility by Indian FDA
Approved by Health Canada in Jan 2012 for Old Facility and currently
under process for New Facility
Managed by well experienced professionals from Multinational Companies
and Contract Testing Laboratories
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
2
3. Management Team
• Over 30 years experience in the pharmaceuticals industry
Mr. Suresh Khanna
Chairman
Mr. Vijay Kumar
Ranka
Director - Operations
• Set-up one of the largest contract manufacturing company in India and catering to
customers like GSK Pharma, GSK Consumer, Novartis, J&J, Pfizer, Wyeth,
etc…..
• Former member of the board of Millipore India
• Founder of KPO providing back-office regulatory services to MNC’s in Europe
• Worked in area of transgenic using Micro-injection, Data curation in
disease
pathway identification, Bio-analysis, Impurity identification, Metabolite identification,
Enzyme based assays, Characterization of biopharmaceuticals
and
Herbals
marker identification.
• Past positions at NCBS, Jubilant Biosys, Synchron Research & Waters Corporation.
Dr.Kishore Shenoy
Vice President Operations
Dr.Mahesh
Formulation - Head
• He comes with enriched experience of about 30 years in the area of
Pharmaceutical Development, Analytical and Quality operations.
• Past positions experience with major Pharmaceutical companies like Shriram Labs
, Micro Labs Ltd and NABL Technical Assessor
•Rich experience in Pharmaceutical Technology of Current and Advance drug
formulation with Doctorate in Pharmacy.
•Past experience of 10 yrs in renowned organizations likes Alembic Ltd, Zydus
Cadila, DRL, etc. Worked in R&D, and capable to formulate conventional & various
advanced dosage forms/Technologies like Tablets, Capsules, Solution, Suspension,
Pellets, Dry Powder
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
3
4. Regulatory Compliance Status
●
Approved by Health Canada in Jan 2012 for Old Facility, new facility was
successfully audited in 2013 and awaiting Approval letter
●
Laboratory Assessment was done by NABL (National Accreditation Board
for Testing & Calibration Laboratories) – India as per ISO / IEC 17025:2005
and expecting to receive accreditation certificates by End of November
2013
●
Audited by WHO, Geneva; under Prequalification Medicine Program –
Procedure for Assessing the Acceptability, in Principle of QC Laboratory for
use by UN agencies; vide LIF No.: L 1108 on 10-12 September 2013 and
awaiting for publication of Inspection Report at WHO Website by November
2013
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
4
5. Lab Approval Clarification – TGA
Guidelines
In addition to Regulatory Approvals like by Health Canada, Stabicon also
meet other regulatory requirements like
●
TGA – Guidance on Release for Supply, for Medicines Manufacturers,
Clause – 6.2 of Version 1.0, June 2013; which states that “6.2 Where
studies in the on-going stability program are contracted out to third
these laboratories do not necessarily have to
be TGA approved. Other certificates may be used in lieu of a GMP
parties,
certification, such as a current Good Laboratory Practice (GLP) certificate or
licence issued by a regulatory authority acceptable to the TGA or a current
ISO 17025 accreditation certificate. Stability test methods used by the
laboratory should be appropriately validated and documented according to
the requirements of the PIC/S Guide to GMP. The AP (Authorized Person)
must consider this as part of release for supply.”
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
5
6. Lab Approval Clarification – TGA
Office
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
6
7. Lab Approval Clarification – MHRA
Office
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
7
8. Lab Approval Clarification – IMB Office
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
8
9. Quality Management System
WHO
cGLP / cGMP
21 CFR Part
210 / 211
ISO /IEC
17025
Quality
Manual
Quality
System / Assurance
Procedures
Standard Operating
Procedures
● Quality Manual (QM) based on
♦
♦
♦
♦
♦
♦
♦
ISO 17025 : 2005
WHO GPQCL
USFDA 21 CFR Part 210 / 211
MHRA / EMEA
Division – 2 of FDR, Health Canada
Our Quality Strategies
Our Businesses Process
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
9
10. Organogram
Management
Business
Development
Accounts &
Administration
QC Laboratory
Project
Management
& CRM
Formulation
R&D
Chemical
&
Instrumentation
Microbiology
Lab
STABILITY MANAGEMENT
Quality Assurance
Sample
Registration
Sample
Archival
Data
Archival
Data
Review
&
Issue of
COA
QMS
&
Regulatory
Compliance
Customer
Complaints
&
Investigations
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
10
11. Facility Highlights
Independent
building,
3 levels,
15,000 sq. ft.
Built-up area
Dedicated
Facility for
Segregated
facilities for
Captive
Formulation
Development
Instrumentation,
Power
Wet Chemistry,
Generation
(Tablets,
Capsules,
Liquid
Orals,etc..)
Microbiology.
&
Stability Project
Management
Support
Fully
Compliant
with EHS
Regulations
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
11
12. Product Development - Highlights
●
●
●
●
●
●
Development strategy and business case
●
●
●
●
●
Scale up and process optimization and stability
Project Time Lines and mile stones monitoring
Administrative licensing activities
API / Excipient / Packing materials sourcing and vendor screening
Non infringement for API / formulation
Formulation trials for robust composition to understand process variables on
QbD basis.
Quality risk assessment and Quality attributes
Process Validation
Quality dossier documents
Customer communication and building transparency, confidence and
buoyancy
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
12
13. Formulation Equipment
State of the Art Equipment Enabling all Unit Operations
● Dispensing: Under laminar flow bench with calibrated balances
● Sifting: Vibratory sifter of 12” diameter
● Granulation: Rapid Mixer Granulator for wet granulation of 1 – 5 kg
● Drug layering: Wurster column Bottom Spray coating of pellets up to 5 kg
● Top spray: Powder coating and top spray granulation up to 5 kg
● Drying: Fluid bed drier of 5 kg capacity.
● Milling: Multi mill with capacity of 50kg/hr
● Blending: Octagonal blender of handing 2 – 10 kg
● Tabletting: 16 Station Tablet press
● Coating: Auto-coater of handing 1 – 5 kg tablets – Film coating, MR Coating & Sugar
coating
● Liquid preparation: Stirrer, Semi automatic bottle filling and capping machine
● IPQC analysis – Balances, Hardness tester, Friabilator, pH meter, Moisture balance,
DT apparatus, BD apparatus, Leak test apparatus. etc.,
● Packing: Blister packing machine
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
13
14. Formulation Services Offered
●
●
●
●
●
●
Platform Technologies like:
Immediate and Modified release
Wurster Pellet coating
Powder coating and Taste masking
Specialized drug delivery
Dosage forms like:
IR/SR/ER/GR/Chewable/Orally disintegrating/Floating/Dispersible Tablets; etc.,
Hard Gelatin Capsules
Liquid orals for pediatrics and bulk
Semisolid topical like Ointments and creams
Development trials as proof per customer dossier for site transfer
Non-infringing formulations
Addressing of regulatory queries on product development
Cost effective formulations and trouble shooting in developed / registered
composition
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
14
15. Laboratory Highlights
●
Stability Projects are monitored & maintained using Validated LIMS
Software
●
HPLCs are on Empower Net-working Software in compliance with
21 CFR Part 11
●
Stability Chambers & Incubators Data Monitoring using validated
ICDAS Software
●
All Analytical Equipment data back-up done periodically on Dedicated
Server
●
RO
Water
System
●
●
●
Access Control Systems
Purification
Fire Alarm Systems
Smoke Detection Systems
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
15
16. Analytical Services Offered
CORE ANALYTICAL SERVICES
●
●
●
●
●
Stability Programs
Analytical Development & Validation
Bio-waiver Studies (Comparative Dissolution Profiles)
Quality Control Testing
Microbiological Testing
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
16
17. Stability Programs
●
●
●
Long-term Stability Studies
Accelerated Studies
Photo-stability Testing
ICH Compliant
Storage Chambers
25° 60%RH
C/
30° 65%RH
C/
30° 75%RH
C/
40° 75%RH
C/
Photo-stability
24/7
Data Monitoring,
Mobile Alert Systems
&
Engineering
Team
●
●
●
Zone IV Conditions
Freeze Thaw Stability
Customized Study
Chambers & Software
Qualified as per
21 CFR part 11, ICH
&
GAMP-V
Guidelines
Current Capacity
55,000 Liters
Scalable to
200,000 liters
To accommodate
6000 to 25000
Batches
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
17
18. Stability Programs
We undertake Stability Programs of
●
●
●
R&D & Pilot Batches
Process Optimization Batches
Validation Batches
●
●
●
Follow-up Batches
Commercial Batches
On-Going Batches
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
18
19. Method Development & Validation
●
●
●
●
●
Verification of Accuracy & Adoptability of the Developed Method
●
Method Development & Validations for
Development & Validation of Stability Indicating Methods
Analytical Method Transfers
Re-validations / Partial Validations As Per Customer Requirement
As per requirements of ICH, USFDA, MHRA, MCC, WHO, ANVISA, etc..
♦ Assay
♦ Dissolution
♦ Uniformity of Content
♦ Related Substances
♦ Degradation Products
♦ Identification
♦ Purity
♦ Preservatives
♦ Anti-oxidants
♦ Colourants
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
19
20. Biowaiver Studies
●
Development
of
Dissolution Methods
●
Performing CDPs as per various
Regulatory Requirements like WHO,
USFDA, MHRA, TGA, MCC, ANVISA,
etc…
●
Conclusions based on Classification
of Drug Molecules
●
F1 / F2 calculations for acceptability of
Bio-waivers
Discriminating
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
20
21. Pre-Despatch QC Testing
●
●
●
●
●
●
●
●
Raw Materials (Exceipients / APIs)
Oral Solid Dosage Forms
Oral Liquid Dosage Forms
Ointments / Creams / Gels / Soft Gels
Sterile Products
Ophthalmic Products
Cosmetics Controlled By FDA
Pharmaceutical Water Analysis
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
21
22. Microbiology
●
●
●
●
●
●
●
●
Validation of Microbiological Tests
Bio-burden Tests
Bacterial Endotoxins by LAL
Antibiotic Assay
Preservative Efficacy Testing
Efficacy Testing of Antibiotic Activity
Efficacy of Chemical Disinfectants
Environmental Monitoring,
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
22
23. Laboratory Operation Process
Samples
Sample
Registration
QC
Manager
Issue of Analytical
Work Plan
Allottment of Samples
to Analysts
Contract / Order / Samples
Proposal / Invoice
Contract / Order
Customer
Relations
Management
CoA / Test
Report
CoA / Test Reports
Technical
Communications
Analysts
Archival
Execution of Analysis &
Data Generation
Analytical Reports & Raw data
Residual Samples
QA
Manager
Reviewed raw data
Analytical Data
Review Team (QA)
Stabicon Life Sciences
A partner for all your analytical needs
QA
QC
Project
Team
Sep 2013
23
24. Business Operation Process
Confrimination
Protocols
NOC Allotment
Form
Shipment
Clearance from
Customs
Sample
Shipment
Contract
Agreements
Technical /
Quality
Agreements
NOC to Import
Samples
(4-6 weeks)
Facility Audit &
Approval
Samples shipment details,
Information of Damage if any
Sample
Registration &
Work Plan
Quotation / Bid
Query /
RFQ / RFP
CDA
CoA / Test Report
Tech. Communiq.
Review of Data &
Reporting Results
Stabicon Life Sciences
A partner for all your analytical needs
QA
QC
Execution of
Analysis
Project
Team
Sep 2013
24
25. Clientele
●
Analytical Method Development & Validations / Stability Studies for
a) Highly regulated markets like USA, Canada, UK, EU Countries & South
Africa,
b) Russian, CIS, Middle East & Developing countries
●
Approved by large Indian and other MNC’s for Method Validation and
Stability Studies for their International markets
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
25
26. Why Stabicon ?
Conceptualized Project Management
Robust Regulatory Documentation
Assured Confidentiality on Product Technology & Data
Well Experienced Professionals who add value to your thought
process by understanding your needs during Product Development,
Validations and Dossier Registration till receipt of MA
We deliver to International Quality Standards at Competitive
costs
Open for Transparency like Data interface through Web-access
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
26
27. Website
For detailed information & RFQ, please visit our website
www.stabicon.com
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
27
28. Thanks
For any query,
Please contact us at
Stabicon Life Sciences Pvt. Ltd
Plot No. 28,
Bommasandra Industrial Area (Sublayout),
th Phase, Jigani hobli, Anekal Taluk,
4
Bangalore - 560 100 (INDIA)
Phone: +91 80 2783 9259 / 60
e-mail : info@stabicon.com
Stabicon Life Sciences
A partner for all your analytical needs
Sep 2013
28