EMA published revision 3 of GMP Chapter 1 and renamed it to “Pharmaceutical Quality Systems”, as refered to ICH Q10, and Chapter 7 “Outsourced Activities”.
The deadline for coming into operation of both chapters is 31 January 2013.
Contact us today for more information or on how to integrate PQS and QRM at: talk@comes-services.com
Further reading: Current interpretation of Chapter 7 to Annex 11 requirements – Read it online
Within the GxP-regulated environment every firm is using spreadsheets in its daily use. Some are used on an ad-hoc basis for simple calculations or verifications; some are used for calculating quality-decision or product relevant data, which may be used for batch certifications or other quality records and reports.
In any case the design, usage and management of spreadsheets should follow a risk-based validation approach. Very often the MS Office application “MS Excel” is used for spreadsheet calculations, but also other (similar) or open-source software may be used.
The ISPE GAMP 5 standard does provide one single chapter in a special topics area for the special “system” type of “IT applications” – this is more or less described on one page of the entire guidance document. To understand the expectations of an inspector it might be useful to reference to the Draft version of the EU EudraLex Vol. 4 – Annex 11 – Computerised Systems ref. Section 3.8. Also this section was not taken over to the final version of Annex 11 (Revision 2011), it is showing the challenges and the expectations from a regulatory point of view.
Source: Annex 11 Draft Version – February 2008
3.8 Spreadsheets should be suitably checked for accuracy and reliability and stored in a manner which ensures the appropriate version control. The calculations should be secured in such a way that formulations are not intentionally or accidentally overwritten. The calculations should be executed with precision displayed on the screen or in reports. Formulations should also be protected from accidental input of in appropriate data type (e.g. text in a numeric field and or a decimal format into integer field).
One of the major hurdles in validating spreadsheets is that these are normally purely file-based and stored on a more or less secured file server location on the basis of the operating system. The above mentioned “appropriate version control” of files and requirements for avoiding the “overwriting” of them seems to be insolvable if not transferred to a better (unique) platform.
Therefore CCS has developed together with the solution partner “ott+partner” – http://www.ott-partner.com/ a basic spreadsheet platform (BSP Solution), which is enabling pharmaceutical companies to use validated spreadsheets in their daily business cases and executions.
Our BSP solution is based on the fundamental architecture and principles of database objects and can be totally integrated in any customer system landscape, if required to already implemented solutions like ERP systems, LIMS, or Document Management Systems (e.g. on the basis of MS SharePoint). In any case the BSP solution will be the secured and central point for all spreadsheet applications and do fulfil the technical and procedural requirements to the best practice principles for a risk-based validation. In addition features like electronic signatures or dedicated approval workflows can be implemented and spreadsheets are easy to use and to validate.
Contact us today for more information or an online demo at: talk@comes-services.com
The second QM Forum in Ulm, Germany was held on 20. Juli 2012 to help manufacturers implementing modern quality systems and risk management approaches to meet the regulatory requirements.
Read now a summery of the event and speakers online: Open Link. (only available in German language) and Open Link (bio.pro.de).
The initiative is on tour throughout the whole of Germany, to communicate the goals and contents of the BMBF’s supporting programme ”Biotechnology – seize and design chances“.
The focus is the connection between research on the one hand and the development of innovative products and procedures on the other hand. Because the path from the idea to the biotechnological result has a huge potential for employment, the competitive ability of Germany and the future of every individual. The aim of the campaign is to demonstrate these chances, motivate people to use them and give them the necessary knowledge to do so.
Mobile experience world BIOTechnikum in Ravensburg, Germany – read more – sponsored by comes compliance services.
Open our BioLAGO announcement here for more details and presentation schedules: OPEN
Training details of the CSV Training in Germany can be found here: External Link to PTS
For more information contact us: talk@comes-services.com
Durham NC / Ravensburg, Germany , September 14th, 2012
Phamedics Consulting is delighted to announce a strategic consulting partnership with comes compliance services. comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements.
This partnership will allow comes compliance services to continue to expand its excellent compliance services by utilizing Phamedics Consulting as partner to provide Quality & Compliance services throughout the United States especially to the Triangle region of North Carolina, the South East Pharma and Biotech corridor of the US.
The two firms compliment one another`s quality and compliance service offerings and will work together to provide clients with excellent services in cGMP compliance, Project Management, Quality Systems Improvement and Validation.
About Phamedics Consulting
Phamedics Consulting is a project consulting firm focused on supporting the pharmaceutical, biotechnology, medical devices, food & beverages, clinical research, cosmetics, consumer products and other FDA regulated industries solve the complex challenges and decisions facing their company today. Phamedics Consulting offer Quality & Compliance solutions and project management consultant services to a diverse range of regulated industry clients. Please visit our website to learn more about services at www.phamedics.com
About comes compliance services
comes compliance services is a European based, highly experienced, boutique consulting company specializing in simplifying and streamlining EMA, FDA, ICH, GHTF quality systems, and fulfilling validation and regulatory compliance requirements. At comes compliance services (CCS), we strongly believe that quality and compliance management will drive continuous improvement and performance optimization. We utilize a more proactive and risk-based approach to quality assurance and validation backed by proven expertise and electronic tools from our partners. We focus on value-added project, process and risk management to achieve regulatory compliance and inspection readiness. The following services and products are available to GMP, GLP, GCP and medical device regulated companies and suppliers:
We invite you to explore our website and learn more about our capabilities, spectrum of services, contact information, and much more at www.comes-compliance.com and www.auditservicecenter.com .
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
In July 2012, the new pharmacovigilance legislation will come into effect across the European Union, according Regulation (EU) No 1235/2010
and Directive 2010/84/EU.
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 Gateway. 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
CCS executed an inhouse training for EudraLex Vol. 4 – Annex 11 (Revision 2011) & Chapter 4 including 21 CFR Part 11 at a pharmaceutical global player. Read more here: Open (German – external link).
Contact us today for more information: talk@comes-services.com
Open the Flyer 2 QM-Forum Web_final for more information and registration.
Event: 2. Ulmer Qualitätsmanagementforum
Das moderne QM-System – Risikobasierte Ansätze – Theorie und Praxis
20. Juli 2012 ab 10:00 Uhr im Ludwig-Erhard-Saal, IHK Ulm
By the cluster of BioPharMaXX.
Event is based on PIC/S: pi-038-1-aide-memoire-on-assessment-of-qrm-implementation (2012)
