ISPE issued the second edition of the GAMP® Practice Guide: A Risk-Based Approach to Testing of GxP Systems. This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP® Good Practice Guide has been recently expanded and updated to conform to GAMP® 5 standards and terminology.
Sie sind ein selbstständiger Berater oder Freelancer im GxP – regulierten Bereich oder haben die Absicht sich selbstständig zu machen? Gemeinsam mit anderen professionellen Mitgliedern in einem renommierten Netzwerk sind verschiedene Vorteile für Sie umsetzbar.
Lesen Sie mehr in unserer Broschüre: Freelancer für CCS broschüre
Kontaktieren Sie uns via Email – freelancer@comes-services.com.
CCS has published its new Collaborative Consulting Framework Matrix, which defines different options of consulting and delivery solutions.
Please contact us at talk@comes-services.com for more information and details.
The Global Harmonization Task Force (GHTF) website is no longer operational at http://www.ghtf.org/.
The site was moved to the International Medical Device Regulators Forum at http://www.imdrf.org/. The archived documents can be found at: http://www.imdrf.org/ghtf/ghtf-archived-docs.asp
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization.
It is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF), and to accelerate international medical device regulatory harmonization and convergence.
Annex 11 (“Computerised Systems”) and Chapter 4 of January 2011 have been revised in response to the increasing use of electronic documents within the GMP environment by the EMA (European Medicines Agency). Two years later (January 2013) we would like to reflect the current status of the implementation at some agencies and the pharmaceutical industry.
Download the article here: Computer System Validation 2013
If you have questions or comments, please contact us at talk@comes-services.com.
If you are a compliance subject matter expert, consultant, or professional in the areas of GMP, GDP, GCP, GLP or medical devices and you are seeking for a project assignment, you can contact CCS by email at freelancer@comes-services.com right now.
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
