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Audit Service Center – Success Story – from an Idea to a Vision to a Solution for Customers

comes compliance services started 3 years ago their service delivery package named to “Audit Service Center” (ASC) to several local and global pharmaceutical customers. To date the services are used by several pharmaceutical companies to outsource their audit management of manufacturers of materials, products, components, and services providers, in GMP, GCP, GDP, GLP regulated industries such as pharmaceuticals, biologics, medical devices, cosmetics, dietary supplements.

ASC – one of the leading external audit management service providers in Europe: How does this work? It is not only the audit execution by checklists for CCS customers or providing a web-based audit management tool, also to initiate shared audits between our customers, linking to the QPSHARE database, performing audits and also to control and monitor or even to support correction action plans.

Contact us today for more information and benefits using the ASC solution: contact@auditservicecenter.com

 

 

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New EMA Pharmacovigilance Legislation 2012 – electronic submission of information

In July 2012, the new pharmacovigilance legislation will come into effect across the European Union, according Regulation (EU) No 1235/2010External link icon and Directive 2010/84/EUExternal link icon.

According EMA this legislation is the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It has significant implications for applicants and holders of European Union marketing authorisations. The European Medicines Agency is responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation is effective from July 2012.

Regulation 1235/2010 states that by 2 July 2012, marketing-authorisation holders will need to submit information to the Agency on medicinal products for human use authorised or registered in the EU using an electronic format provided by the Agency. Marketing-authorisation holders will also be responsible for maintaining this information once submitted. The European Medicines Agency is progressing with the implementation of the electronic submission of information on medicines (read more).

The Agency published the format for the electronic submission of medicinal product information in July 2011 as XML Schema Definition (XSD), submitted via the EudraVigilance GatewayExternal link icon. On 5 March 2012, the Agency published an update of the format, including detailed guidance, Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) messaging schemas, controlled vocabularies and frequently asked questions. The Agency maintains its plan to update the initial format published in July 2011 in line with the International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP) standards. The IDMP standards are scheduled for finalisation during the second half of 2012.

comes compliance services (CCS) offers consultancy services for the implementation road-map and integration of e-reporting and submissions based on the regulatory requirements. Contact us today for more information and our service options related to e-reporting and submissions to the agency: talk@comes-services.com

 

 

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US-FDA: Training and Continuing Education – CDER World

US-FDA CDER offers following training courses online.
E-learning courses currently available in CDER World:

World of Compliance  (October 20, 2011)

Course Outline:

  • Lesson 1: Office of Compliance Overview
  • Lesson 2: Manufacturing and Product Quality
  • Lesson 3: Scientific Investigations
  • Lesson 4: Bioequivalence and Good Laboratory Practice Inspection Programs
  • Lesson 5: Enforcement Responsibilities
  • Lesson 6: Risk Management and Drug Surveillance

World of Generic Drugs  (October 20, 2011)

Course Outline:

  • Lesson 1: Generic Drugs Overview
  • Lesson 2: Abbreviated New Drug Review Process

World of New Drugs  (November 14, 2011)

Course Outline:

  • Lesson 1: Role of Office of New Drugs
  • Lesson 2: The Drug Review Process
  • Lesson 3: Biologics Review
  • Lesson 4: Pediatric Regulations

World of Drug Safety (April 13, 2012)

Activities and responsibilities of CDER’s Office of Surveillance and Epidemiology (OSE)

Web Site / Source: check for updates 

provided by U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)

More trainings and information at www.comes-services.com

 

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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.

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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.

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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 )

 

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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

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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.