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.
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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.
RMD24 | Debunking the non-endemic revenue myth Marvin Vacquier Droop | First ...BBPMedia1
Marvin neemt je in deze presentatie mee in de voordelen van non-endemic advertising op retail media netwerken. Hij brengt ook de uitdagingen in beeld die de markt op dit moment heeft op het gebied van retail media voor niet-leveranciers.
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Memorandum Of Association Constitution of Company.pptseri bangash
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A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
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Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
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Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
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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