Pharma 2.0: towards paperless production – Interview by BioPro – Baden Württemberg

Interview by BioPro – Markus Roemer – towards paperless production:

Read the interview in English here: OPEN

Read the interview in German here: OPEN

The Biotech / Life Sciences Portal Baden-Württemberg is run by BIOPRO Baden-Württemberg GmbH. Working in close cooperation with our authors from the Rhine-Neckar Triangle, STERN, Freiburg, Ulm and BioLAGO bioregions, we present the highlights of Baden-Württemberg research, the products and developments of Baden-Württemberg companies as well as articles of general interest from the life sciences area. The portal, which is updated on a weekly basis, also provides general information on the region.

comes compliance services is member of the BioLAGO e.V. network – www.biolago.org.

Stay updated with our CCS Android App – Install it now…

Stay updated with our CCS Android App: Download

Installation: Right-click on the download link “save target as” – save and unzip the file on your PC, transfer and install it on your Android SmartPhone.

You will automatically receive current news and information from CCS services, events, and news including our validation network updates.

MS SharePoint webinar – 16th April at 14:30-15:30 GMT

 

MS SharePoint webinar – 16th April at 14:30-15:30 GMT – open link for registration: GXPI eshot ‘Great – It’s Another Webinar’ 280312

  • examine the setup, management and consumption of documents supporting a PQS (Pharmaceutical Quality System) according ICH Q10.
  • explore the management of lifecycle and control of documents (documentation and records according GMP Chapter 4).
  • follow the workflow and approval of the documents in a clear and straight forward manner.
  • discuss the wrap-around processes necessary to meet compliance requirements with these controlling type documents, such as Periodic review and Document Distribution.

GxPi works upon the principal that complex issues can be simplified to deliver long term business benefit, better efficiencies and cultural change. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector. GxPi’s products, x-docs™ and x-train™, provide enterprise grade electronic Document, Content and Compliant training solutions. GxPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems. (For more information, please visit www.gxpi.com )

 

Shared Audit Setup with QPShare

Our latest recommendation: How to find and setup a shared audit with other companies and QPs?

At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons.

In a first step QP Association members were asked to submit data about their suppliers using standardised Excel sheets, including name, country, address as well as the relevant products (APIs and excipients). These data were used to identify those suppliers more than one QP were interested in and to inform the QPs who named the supplier in question. Based on this information the QPs had the option to set up a joint audit of the supplier, e. g. by one of the QPs or by a third party, and to share the information. The approach of this project is very similar to that of a pilot project that was initiated by different authorities (e. g. FDA, EMA, EDQM, TGA) to identify those companies more than one authority wants to inspect. As a consequence, one authority might conduct an inspection and share the results with other partners.

The QPSHARE database displays potential suppliers more than one QP is interested in. Members of the European QP Association are able to identify suppliers and the number of QPs interested in auditing the supplier. Confidentiality will be maintained as the names of the QPs will not be displayed. If a member would like to contact the QPs related to a certain supplier, a button allows the member to send an automatic message to the other QPs. Only if the QPs who receive the message are interested they may disclose their identity and contact the colleague. Read more about QPSHARE.

If a common shared audit is found the audit plan, execution and reporting might be managed and controlled by the independent Third Party of Audit Service Center at CCS.

Contact us today at: contact@auditservicecenter.com or talk@comes-services.com

CCS looks back on a successful 2011

comes compliance services (CCS) in Ravensburg continued double digit growth in 2011 by serving best-practice compliance services and solutions to a wide range of  GxP-regulated companies and suppliers. Achieving high levels of customer satisfaction and meeting the expectations & project requirements require that CCS continually monitor and improve compliance strategies and concepts.  Key to our business success is the level of customer repeat business and satisfied new customer wins in 2011 – by providing projects On-Time and On-Budget by utilizing highly competent and skilled consultants.

Our CCS Project Examples – successfully executed and finished in 2011:

  • Implementation and Validation of Production Systems and SCADA
  • Implementation and Validaton of Electronic Batch Recording Systems
  • Qualification and Validation of Building Management Systems
  • Support and Execution of PQRs and compliance programs
  • Validation of ERP, DMS, LIMS, QMS IT-Systems from several vendors
  • Training executions (public and in-house) and speaking at several GMP events
  • Consultancy PQM Systems: Quality Risk Management implementation
  • Audit and Inspection Preparations and Support, Pre-Audits and Action Plans
  • Production Quality Coverage and Quality on the Shop Floor concepts
  • Execution of Quality Periodic Reviews and Reporting / Trending
  • Assessments of GMP and medical device compliance
  • Process and Cleaning Validation for different products
  • Third Party Audit execution and reporting
  • SOP Development, Training Management, and Reality Checks
  • Validation and Qualification of laboratory systems
  • PAI support and verification, corrective actions planning
  • Support of Audit Programs and Concepts
  • Implementation and Validation of electronic deviation and CAPA systems
  • Annex 11 compliance checks and reporting
  • Validation of electronic requirements and test tools / applications
  • Support and Execution of Quality Remediation Plans
  • Implementation and Qualification of hygienic zones concepts and methods
  • Implementation of ICH Q9 and ICH Q10 including training

Contact us now for more details and references at talk@comes-services.com.

CCS joins MESA.org as member

comes compliance services joined the MESA International organisation: MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders and solution providers who are focused on improving Operations Management capabilities through the effective application of technology solutions and best practices.

Read  more.

bwcon 2011: CCS networking

CCS membership at bwcon 2011: Baden-Württemberg connected – Read more…

Baden-Württemberg: Connected e.V., or bwcon for short, is the top business initiative promoting Baden-Württemberg as a high-tech location. As one of the most successful European technology networks, bwcon connects more than 460 companies and research institutes. Currently more than 4,600 experts are benefiting from systematic networking via the bwcon hub. The added value generated by bwcon is to be found in the possibilities offered by new cooperation projects and connections.

GMP Paperback Computer System Validation Revision 2011

GMP Verlag published the new ‘GMP Paperback CSV’ in July 2011, written by Markus Roemer.

It contains a current view on Annex 11 – Revision 2011, basic requirements of ISPE GAMP 5, quality risk management, and up-to-date validation strategies and special topics (e.g. ERP, Excel, data migration, and much more).

Read more: GMP LogFile #9  from July 2011 (German)

This version of the paperback book is written in German language – the English version will be issued in September 2011.