According ISPE GAMP 5 – Page 11 – appropriate schemes for assessing and improving organization capability and maturity should be used, such as the Capability Maturity Model Integration (CMMI) for development. As such most companies which develop systems and software for the GxP related industry hold an ISO 9001 certification.

Download here the Version 1.3 of the current CMMI standard for development: DOWNLOAD DOC – CMMI_Dev-V1.3

Also a listing and mapping between ISO 9001 and CMMI can be downloaded here: DOWNLOAD PDF – CMMI_ISO-9000-2000-mapping

Contact us today for more information to GAMP compliant software and system development at: talk@comes-services.com

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 .

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.