GAMP Training: GxP Process Control Systems

This new, highly interactive, course describes how the:

GAMP® Good Practice Guide: A Risk Based Approach to GxP  Process Control Systems

may be applied to achieve process control systems that are fit for intended use and meet current regulatory requirements. The course is executed by ISPE Europe in Prague – 7-8 October 2013.  READ MORE

Contact us for more information or possible in-house trainings and coaching by CCS at: talk@comes-services.com

 

 

 

GxP Quality Agreements – CCS Services

Contract manufacture and analysis must be correctly defined, agreed and controlled in order to avoid misunderstandings which could result in a product or work of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly establishes the duties of each party. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities. These processes should incorporate quality risk management principles.

A Contract should be drawn up between the Contract Giver and the Contract Acceptor (also called as Contracted Facilities) which specifies their respective responsibilities and communication processes relating to the outsourced activities. In particular, such contracts should describe how parties can utilize written Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.

A Quality Agreement is a comprehensive written agreement that defines and establishes the obligations and responsibilities of the Quality Units of each of the parties. In general, the Quality Agreement should clarify which of the CGMP activities are to be carried out by each party per the applicable regulations under EU EudraLex or US FDA GMP and other regulations that may apply. Formal agreements are required according Annex 11 for suppliers and service providers.

  • EU EudraLex Vol. 4 – Chapter 7 – Outsourced Activities (revision 1)  – OPEN LINK (January 2013)
  • US FDA Guidance for Industry – Contract Manufacturing Arrangements for Drugs: Quality Agreements (Draft) – OPEN LINK (May 2013)

CCS offers risk-based consultancy services for:

  • Analysis, Setup, and Reviews of Quality Agreements – Verification of contracts between Contract Giver and Acceptor;
  • Compliance check of Quality Agreements and/or Service Level Agreements within GxP Outsourcing programs;
  • Verification of Quality Risk Management principles related to planned activities;
    • Establish and maintain quality oversight of contracted manufacturing operations incl. audit support;
    • Establish electronic solutions for quality documents and records (e.g. electronic records) including handover processes from Contract Acceptor to Giver;
  • QP services related to outsourced activities and on-going support;
  • Solutions for Quality System elements and records, like EBR, laboratory records, deviations, CAPA, changes, logbooks, etc. managed by the Contract Acceptor and valid transfer to Contract Givers.

Contact us for more information at talk@comes-services.com .

CCS listed in the ISPE Buyers Guide

CCS is now also listed in the ISPE Buyers Guide. Check it online here.

The international ISPE Buyers Guide is a comprehensive resource for products and  service buyers. This directory includes manufacturers and service providers who  recognize the importance of the ISPE audience and tailor their products and services accordingly to it.

Update: New ISPE publications catalog (July 2013)

Contact us now for more information at talk@comes-services.com

 

GDP – Revised rules in the EU – 2013/C 68/01

The revised GDP guidelines introduce the following changes:

  • the maintenance of  a quality system setting out responsibilities, processes and risk management principles in relation to wholesale activities;
  •  suitable documentation which prevents errors from spoken communication;
  • sufficient competent personnel to carry out all the tasks for which the wholesale distributor is responsible;
  • adequate premises, installations and equipment so as to ensure proper storage and distribution of medicinal products;
  • appropriate management of complaints, returns, suspected falsified medicinal products and recalls;
  • outsourced activities correctly defined to avoid misunderstandings;
  • rules for transport in particular to protect medicinal products against breakage, adulteration and theft, and to ensure that temperature conditions are maintained within acceptable limits during transport;
  • Specific rules for brokers (person involved in activities in relation to the sale or purchase of medicinal products).

Read more at: http://ec.europa.eu/health/human-use/good_distribution_practice/index_en.htm

The revised guidelinespdf will enter into force in six months from the date of publication, on 8 September 2013.

Aktueller Trainingsplan der PTS für 2013

Aktueller Trainingsplan der PTS für 2013 – Validierung und Qualifizierung von IT Anwendungen und IT Infrastruktur:

Den aktuellen Trainingsplan der PTS für die IT-Informationstechnologie finden Sie in einer Gesamtübersicht hier online:  LINK

 

Mit Teilnahme der: CCS logo 2010 xs

Fragen und Antworten zur ISPE Mitgliedschaft

Überlegen Sie sich vielleicht gerade, ob Sie ein Mitglied bei der ISPE werden wollen oder sollen? Was bringt Ihnen eine Mitgliedschaft dort und was können Sie daraus gewinnen?

Herr Markus Roemer von der CCS ist der Botschafter für die ISPE DACH (Deutschland – Österreich – Schweiz). Gerne beantwortet er Ihre Fragen rund um die Mitgliedschaft und welche Vorteile Sie nutzen können.

Gerne nehmen wir uns Zeit für Sie und beantworten gerne persönlich Ihre Fragen. Kontaktieren Sie uns via email: talk@comes-services.com

Download Broschüre ISPE: ISPE-Mitgliedschaft-CCS