Concept paper on revision of Annex 15 of the GMP guide – Announcement: Annex 15 – draft – December 2012
Gute Vertriebspraxis GDP 2013/C 68/01 Leitlinie
Download the EU GDP Guideline here in German or English language.
- Gute Vertriebspraxis: GDP Leitlinie auf Deutsch zum Download: GDP_2013_C 68_01_DEUTSCH DE
- Good Distribution Practice: GDP Guideline in English Language – Download: GDP_2013_C 68_01 EN
Die überarbeitete Leitlinie tritt 6 Monaten nach der Veröffentlichung am 8. September 2013 in Kraft.
The guideline will enter into force in six months from the date of publication, on 8 September 2013.
21 CFR Part 11: References & History
As Part 11 solution provider CCS provides this reference listing:
- 21 CFR Part 11 – Final Rule – OPEN HTML
- ISPE White Paper – Part 11 – OPEN PDF
- Guidance for Industry – Scope and Applications – OPEN PDF
- FDA announcement 08-July-2010 (21 CFR Part 11)
Contact us now for more information at: talk@comes-services.com
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
GxP Training Records Management
Managing and automating Compliance Training records: OPEN PRESENTATION
Visit our solution partner GxPi Ltd. at www.gxpi.com
Business Review Webinar Presentation: OPEN PRESENTATION
Questions? Contact us 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 guidelines will enter into force in six months from the date of publication, on 8 September 2013.
Jubiläumsveranstaltung: 5 Jahre BioLago e.V.
5 Jahre BioLAGO – Feiern Sie mit uns!
Als Mitglied und Sponsor laden wir herzlich ein zu der Jubiläumsveranstaltung anlässlich des 5-jährigen Wirkens des BioLAGO e.V. mit einer Geschäftsstelle. Blicken Sie mit uns auf die Meilensteine zurück sowie in die Zukunft der Life Sciences am Bodensee.
Mehr Informationen unter: OPEN LINK