About the KIPA Team of Experts

Legal Notes

2013-11-07T19:44:38+01:00

Legal Notes

KI Pharma Alliance GmbH
Wilbrandtgasse 4
3400 Klosterneuburg
Austria

Managing Director: Dipl.Kfm. Joerg Kloppert

Tel: +43-2243-23017-0
Fax: +43-2243-23017-20
Email: office@kipharma-alliance.com
Web: www.kipharma-alliance.com

Company Register no.: FN 371197d Commercial Court Korneuburg
VAT ID: ATU66859535
Place of jurisdiction: Klosterneuburg

Bank details:
Erste Bank AG, sort code 20111
Account no.: 289 685 57900
IBAN: AT91 2011 1289 6855 7900
SWIFT Code: GIBAATWW

Member #1/320373 of the Austrian Chamber of Commerce „WKO”

Business purpose: Consulting including business intermediation as well as trade in goods of any type.

Disclaimer
The content of this website is intended for information purposes only. However, KI Pharma Alliance GmbH does not accept any liability whatsoever for the content provided. KI Pharma Alliance GmbH reserves the right to change the content of this website any time.
KI Pharma Alliance GmbH cannot be held responsible – either directly or indirectly – for any damage or inconvenience resulting from the use or misuse of our information.
KI Pharma Alliance GmbH holds the copyright on all the texts on this website. The material must not be copied, sold, distributed or duplicated in any way without prior explicit written permission by KI Pharma Alliance GmbH.
KI Pharma Alliance GmbH is not responsible for the content of websites of third parties (websites through which a user could access this website or websites which users might access through this website). KI Pharma Alliance GmbH does not accept any liability in connection with such websites or links.

If you are unable to accept the stated terms and conditions for the use of this website, we ask you to leave this website.

Contact Information

2013-11-07T19:23:09+01:00

Contact Information

KI Pharma Alliance GmbH

Headquarter:	Wilbrandtgasse 4 3400 Klosterneuburg Austria, Europe
Office:	Donaustraße 106 3400 Klosterneuburg Austria, Europe
Telephone:	+43 (0)2243 23017 - 0
Facsimile:	+43 (0)2243 23017 - 20
E-Mail:	office@kipharma-alliance.com
Internet:	www.kipharma-alliance.com
Skype:	kipharma

Altogether, our team has 50+ years of experience in the pharmaceutical industry

2013-11-07T15:39:24+01:00

Altogether, our team has 50+ years of experience in the pharmaceutical industry

KIPA employees are project assigned fixed staff members as well as qualified freelancers. We constantly have our team evaluated by our clients and add know how to and personnel as the number of projects increases and their complexity improves.

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Altogether, our team has 50+ years of experience in the pharmaceutical industry read all

2013-11-07T15:39:24+01:00

Altogether, our team has 50+ years of experience in the pharmaceutical industry

KIPA employees are project assigned fixed staff members as well as qualified freelancers. We constantly have our team evaluated by our clients and add know how and personnel as the number of projects increases and their complexity improves.

Business Networking & Portfolio Planning Experts

Highly educated in economics, quality systems and quality auditors
Experience in the generic pharmaceutical industry for more than 20 years in various countries on the globe.
Formerly held senior positions at multinational pharmaceutical companies in Europe, USA and Asia
Several API strategic sourcing projects in India and China

Initiation, monitoring and project management of several product transfers from/to European and Asian sites.
Initiation and management of first EU GMP accreditation project with Bangladesh pharmaceutical company along with CMO contracts with EUbased generic companies
Lecturers in the field of marketing and supply chain
Global key-level contacts in the pharmaceutical industry

Administration & Translation experts

Our multilingual administration and translation team supports our experts while they are away abroad on project assignments on behalf of our clients.
The following languages are available: German, French, English, Hokkian, Mandarin, Cantonese and Malay.

With accumulated glossary know-how, over more than 10 years, our translation services are well appreciated by multinational pharmaceutical companies for their medical registration documentation.

Regulatory & QC experts

Profound professional experience as pharmaceutical technical experts for analytical method development for steriles and non-steriles finished dosage forms
30 years of practical expertise in the pharmaceutical industry in senior management positions (Head of Quality Control, Head of Quality Assurance, Qualified Person etc.)

30 years of practical know-how in regulatory affairs including upgrading of API DMFs, full compilation support in NeeS format Dossiers, ASEAN CTD format dossier compilation, connected with EU regulatory authorities
QM documentation support – QA/QC

Pharmaceutical Production & Utilities Experts

Profound professional experience as pharmaceutical technical experts for sterile and nonsterile finished dosage form production
Profound professional experience as pharmaceutical technical experts for API production
More than 25 years experience in the pharmaceutical industry in various senior positions such as Head of Manufacturing, Qualified Person etc.

Hands-on GMP consulting support in all aspects of production, utilities, process validation and all qualification aspects (IQ/OQ/PQ).
QM documentation support – production and utilities

IT & GAMP Experts

Experienced experts in Information Technology Service Management (ITSM), GAMP (IT-GxP) and ISEC (Information Systems Security) specialists
Multiple ITIL certifications
Excellent knowledge of Computer Systems validation (CSV) and covering many other IT related fields

Previouisly held various managing positions at several multinational companies like Novartis, Sandoz, Pidas in Austria and Canada
Key experts for IT Quality, IT Service Management and IT Security and all related matters including but not limited to training, documentation support and SOP development.

GMP Inspection Experts

Former EU Inspector and freelance hired inspection associates are also part of the KIPA team
Within their sound professional experience gained at EU authorities, these experts are very important in our GMP consulting projects acting as our internal inspector prior to real authority inspections. By performing these mock inspections and follow ups, we are confident that all high level GMP inspections can be passed.

Our experts have conducted numerous regulatory GMP inspections on national and international levels for both API and Finished Dosage form manufacturers.
Our experts gained experience in Asia, The Americas, Asia and Europe.

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KIPA acts as an intermediary and project manager of entire licensing agreements

2013-11-07T15:29:39+01:00

KIPA acts as an intermediary and project manager of entire licensing agreements

KIPA has access to a plethora of interesting generic product lines manufactured according to cGMP guidelines in Europe, Asia and Latin America and can offer the in-licensing and full project management.

Included are:

Contract negotiation
Analytical method transfer monitoring to the EU batch releaser
Supply chain set up according to GDP
Ongoing support during supply period and trouble-shooting if necessary

KIPA manages complete site transfer projects for contract manufacturing

2013-11-07T15:16:37+01:00

KIPA manages complete site transfer projects for contract manufacturing

KIPA establishes contacts between pharmaceutical marketing companies in price sensitive key EU markets and EU GMP accredited production sites for contract manufacturing or new developments

High-class partners are chosen to ensure fully validated transports according to GDP guidelines.

KIPA offers access utilization of a global business partner network

2013-11-07T15:03:22+01:00

KIPA offers access utilization of a global business partner network

KIPA actively performs traditional business networking and has a proven track record in global business intermediation between partners in Asia and Europe from API qualification up to final distribution of the finished products in highly regulated markets in the European Union.

KIPA has a proven track record in setting up and validating an entire cold chain from Bangladesh to European markets and provides overall supply chain set-up support according to GDP (Good Distribution Practices).

KIPA has the full package of regulatory expertise

2013-11-07T14:34:47+01:00

KIPA has the full package of regulatory expertise

Our KIPA regulatory support includes :

Establishing and upgrading pharmaceutical technical dossiers up to CTD format dossiers in NEES format
Monitoring clinical studies and BE study monitoring
Providing medical expert reviews and reports
Managing entire product registration procedures in EU and with WHO

KIPA maintains and constantly updates a partner database of qualified API sources

2013-11-07T14:20:52+01:00

KIPA maintains and constantly updates a partner database of qualified API sources

KIPA helps during supplier selection and supplier qualification.

We perform:

Supplier qualifications of API producers and contract manufacturers
Shared audits of common suppliers in order to reduce costs
Mock inspections, self-inspections and internal audits

The portal to global sources of qualified APIs and FGs.

Technical expertise in product selection and development

2013-11-07T12:57:04+01:00

KIPA's technical expertise in product selection and development

KIPA provides support during product portfolio planning for patent expiry within 5-7 years within key therapeutic areas. Contact us to find out unique product in-licensing opportunities.

KIPA provides analytical method development and product development expertise for selected products in sterile and non-sterile production

KIPA provides full GMP support to achieve PICsGMP/EU GMP or equivalent GMP accreditation

2013-11-06T19:33:07+01:00

KIPA provides full GMP support to achieve PICsGMP/EU GMP or equivalent GMP accreditation

The well-known and respected KIPA team has a proven track record in full GMP (GxP) compliance projects in several ASEAN countries, Far East and South Asia.

KIPA professional GMP training and consulting expertise also attract Health Ministries and government organizations in the ASEAN region.

Our clients achieved PICsGMP/EU GMP or equivalent GMP accreditation within planned timelines, initially set budgets and high-value export business ever since towards regulated markets and within ASEAN region.

Whether you have an API or finished product plant and you see your target growth in export to regulated markets you have to contact the best GMP consulting partner. Contact us and find out how best we can suit your target. We can support you in achieving high performance.

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KIPA provides full GMP support to achieve PICsGMP/EU GMP or equivalent GMP accreditation read all

2013-11-06T19:33:07+01:00

KIPA provides full GMP support to achieve PICsGMP/EU GMP or equivalent GMP accreditation

The well-known and respected KIPA team has a proven track record in full GMP (GxP) compliance projects in several ASEAN countries, Far East and South Asia.

KIPA professional GMP training and consulting expertise also attract Health Ministries and government organizations in the ASEAN region.

Our portfolio of GMP service:

Production site design review and planning support
Project management during cGMP upgrading support (WHO, EU etc.)
GMP and regulatory training programs
Technical support for product transfer, utility qualification, quality system upscaling, validation support, inspection preparation, accompanying and monitoring inspection up to accreditation

Mock inspections, self-inspections and internal audits
Assistance in preparation for international regulatory/authority audits by EU agencies, WHO, ANVISA and TGA
GMP assistance for due diligence projects
Full GAMP consultancy and CSV consultancy (Good Automated Manufacturing Practices and Computerized System Validation)

Basic Principles of GMP

Line opening:

Includes checks on materials and components
Batch number
Expiry date
Printed packaging material including cartons, leaflets, foil . .

KIPA project methodology chart:

Manufacturing processes are clearly defined and controlled.
All critical processes are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled, and any
changes to the process are evaluated.
Changes that have an impact on the quality of the drug are validated, as necessary.
Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)
Operators are trained to carry out and document procedures.

Records are made, manually or by instruments,
during manufacture that demonstrating that all
the steps required by the defined procedures
and instructions were in fact taken and that the
quantity and quality of the drug was as expected.
Deviations are investigated and documented.
Records of manufacture (including distribution) enabling the complete history of a batch to be traced are retained in a comprehensible and accessible form.
The distribution of the drugs minimizes any risk to their quality.
A system is available for recalling any batch of drug from sale or supply.
Complaints about marketed drugs are examined, the causes of quality defects are investigated and appropriate measures are taken with respect to the defective drugs to prevent recurrence.

ITIL®/ITSM, ISEC, GAMP and CSV consulting by KIPA

Authority inspectors tend to increasingly incorporate full GxP compliance in their inspections. In the past, most of these authorities did not put their emphasis on auditing computerized systems as the majority of state-of-the-art pharmaceutical manufacturers have all production related and product release proof established in a well documented QM system. Modern drug manufacturing, however, relies heavily on computerized systems. That is why ensuring quality and accuracy of data is absolutely crucial and that is also why Computerized Systems Validation (CSV) is necessary to assure that critical processes are functioning properly to assure a high quality of the product. During several international GxP inspections, we experienced the enhanced capabilities of authority inspectors who are well-trained in the inspection of such IT systems in order to verify the GxP compliance status also for large-volume and high-tech operating pharmaceutical manufacturers.

Computerized System Validation

CSV is the documented process of assuring that a computer system does exactly what it is designed for in a consistent and reproducible manner. The validation process begins with the system proposal and requirements definition and continues throughout the system‘s whole life cycle up to system retirement and retention of the e-records based on the applicable regulatory rules.

This includes all companies with:

computerized production processes and/or (GMP)
computerized release relevant activities in QC (GLP)
computerized warehouse handling and/or automated shipping (GDP)
or any other IT-based manufacturing, laboratory, clinical, distribution procedure

Companies that have computerized activities with key criticality to the final product but cannot provide these GxP relevant basics will face critical problems during EU/WHO/TGA etc. GMP inspections now and in future.

We have incorporated such requirements in our consulting support concept and are proud to have been appointed in some ASEAN countries as head consultants for CSV compliance review, consultant for establishment of IT quality documentation and consultant for establishment of a complete IT security concept.

For a successful GMP inspection followed by the corresponding GMP certification

all computerized systems involved in the production of drugs in any way have to be validated according to GAMP (Good Automated Manufacturing Practices).
profound IT service management has to be in place to ensure service and support for all production relevant computerized systems according to ITIL (Information Technology Infrastructure Library).
a sufficient Information Security (ISEC) management following certain security standards has to ensure the protection of all highly valuable digital assets.

We are offering the full range of compliance support:

GAMP® and CSV consulting
Computerized Systems Validation services
ITIL® and ITSM consulting
Support organization implementation services
Internal and external auditing services
Vendor management consulting
Vendor negotiation as well as vendor and provider auditing services
SOP, WO, WI and similar documentation development
Physical, ideological and digital information security (ISEC) consulting
Management, IT staff and computer user training

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Full set of KI Pharma Alliance services – The value chain in one hand

2013-11-06T18:59:24+01:00

Full set of KIPA services – The complete value chain in one hand

KI Pharma Alliance GmbH …

… provides full GMP support

to achieve PICsGMP/EU GMP or equivalent GMP accreditation

… allows product selection

and development technical expertise

… maintains and constantly updates

a partner database of qualified API sources

… has the full package

of regulatory expertise

… offers access utilization

of a global business partner network

… manages complete site transfer projects

for contract manufacturing

… acts as an intermediary and project manager

of entire licensing agreements

Foreword of the Management

2013-11-06T13:41:41+01:00

Foreword of the Management by Managing Director Joerg Kloppert, MBA

Based in the proximity of Vienna, one of the most prestigious historical places of Europe, KI Pharma Alliance GmbH is an efficient young GMP and regulatory consulting and business networking company. Since 2010, we have been aligned with our licensing partner pharmavision GmbH, a pharmaceutical company based in Vienna with its distribution partners in EU and ASEAN countries. Since 2012, KI Pharma Alliance also invested substantial funds in the development of a high-class JANTIN sports nutrition line manufactured in a full GMP and HACCP compliant facility. A marketing and distribution alliance was formed in 2013.

I founded KIPA in 2008 with the vision to combine available global pharmaceutical market know how, a global network, high profile GMP knowledge and a loyal team with a view to fulfill the increasing demand for high-class, lean and cost efficient production and fully validated supply chains.

We are very proud of having successfully achieved EU GMP accreditations for several partners in South Korea, Bangladesh, India and the Philippines. Together with these partners KIPA has already established a high-value licensing business for products manufactured at the EU GMP accredited sites. Our GMP consulting projects in the ASEAN region are developing fast and since 2012, we are proud to provide our expertise also to several Health ministry operations in this region.

A substantial segment of KIPA business is a well-balanced technical expertise in combination with high-level GMP expertise. The professional support from well-known experts and team players in this area is a perfect match with the huge pharmaceutical market, business development and project management expertise. The technical and regulatory expert team is the technical interface between KIPA production partners mainly in Asia and marketing partners mainly in the regulated markets of the European Union but also in Brazil and South Africa.

Clients who benefit from the KI Pharma Alliance services are able to enhance their production efficiency, perfect their documentation, increase their development expertise and increase international business activities towards regulated markets in the European Union and other regions at the same time. Also, GMP and regulatory expertise with sourcing, site-transfer management, business development and global business can be chosen each as a separate dish from the overall KIPA service menu.

Find out what we can do for you. We will be delighted to provide our hands-on support and to include you in our network of valuable partners.

Sincerely,
Joerg Kloppert