Category: CCS inside

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.

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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.

• Open Chapter 1 and read it online.
• Open Chapter 7 and read it online.

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

 

 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:

• Quality Management Services
• IT Project Management Services
• Comprehensive and risk-based validation concepts and services
• Validation Tools for Requirements, Project, and Test Management

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 .

 

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