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De nya EU-regelverken MDR och IVDR finns nu som E-böcker (EPUB)

The new regulations published in May 2017 aims to ensure that medical devices and in vitro diagnostic devices remains safe while allowing people with medical needs access to new and innovative treatments. For the industry, this change impacts the process and requirements for placing devices on the market, including changes in device classification.
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EU Medical Device Regulation 745 of 5 April 2017
EU In Vitro Diagnostic Medical Device Regulation 2017/746 of 5 April 2017

New EU Guidelines on GMP specific to Advanced Therapy Medicinal Products

The new Guidelines, developed after extensive consultation with stakeholders, EMA and competent national authorities, adapt the GMP requirements to the specific characteristics of ATMPs and address novel scenarios such as decentralised manufacturing, automated production, and reconstitution of ATMPs. The Guidelines take a risk-based approach, allowing manufacturers some flexibility in their processes and control systems, depending on the level of risk. In addition, the Guidelines describe the traceability data that ATMP manufacturers should keep for 30 years in accordance with Article 15 of ATMP Regulation (EC/1394/2007).

Läs Europakommisionens pressrelease     Ladda ner riktlinjerna


/ Konsulttjänster

Key2Compliance AB har under våren 2017 inlett ett samarbete med Symbioteq Kvalitet AB, där Symbioteq kommer att arbeta mer aktivt med att förstärka vårt utbud av utbildningar inom Medtech och flera av Symbioteqs konsulter kommer att förstärka som utbildare.

Symbioteq arrangerar inte längre egna utbildningar utan kommer att fokusera helt på att bedriva konsultverksamhet och breddar sitt utbud av konsulttjänster från Medtech till Läkemedel och hela Life Science sektorn.

”Vi är övertygade om att samarbetet gör att kundernas behov av såväl konsultstöd som utbildning inom kvalitet och regelverk tillgodoses ännu bättre genom en större tillgänglighet till ett brett sortiment av tjänster inom området”, säger Key2Compliance® styrelseordförande Anna Lundén.

Som ett led i företagens långsiktiga strategi att bli Norra Europas främsta leverantörer av specialisttjänster inom kvalitetssäkring och regelverk för läkemedels och medicinteknisk industri har Symbioteq Kvalitet AB också förvärvat en andel av aktierna i Key2Compliance AB.

Läs mer om våra konsulttjänster

Det nya medicinteknik/in-vitro diagnostik regelverket har antagits av EU

The new rules significantly tighten the controls to ensure that medical devices are safe and effective and at the same time foster innovation and improve the competitiveness of the medical device sector. The new rules also better reflect the most recent scientific and technological progress and set the gold standard for medical device regulation globally. The revised rules also provide the conditions needed to consolidate the role of the EU in the long-term as a global leader in the sector.

Läs mer i Eu:s pressrelease

Reservera 22 maj 10.00-11.30 eller 7 juni 15.00-16.30 för vårt Webinar där vi presenterar nyheter och viktiga delar i reglerna (på engelska)   https://www.key2compliance.com/cs5002.php

Från den brittiska tillsynsmyndigheten MHRA:s blogg:
Too much pressure: a behavioural approach to Data Integrity (Part 1)

In this interesting article David Churchward reflects on the international data integrity workshops in China in October 2016. During the workshops, regulators discussed their findings from inspections where breaches in data integrity had been identified. Issues relating to pressure, motivation, and ultimate disconnection between front line employees and their managers were hot topics; and the inspectorate blog provides an opportunity to share some of this experience.

Läs blogginlägget

Anna Lundén talks about Tendencies and developments to be found in observations and warning letters - Video

Anna Lundén, training director and part owner, Key2Compliance AB discuss with Henrik Johanning, CEO, Genau & More®.

Den slutliga versionen av "Guidance on CGMP Requirements for Combination Products" har nu publicerats

Denna guide beskriver och förklarar regelverket "The final rule on current good manufacturing requirements for combination products" (21CFR4) som publicerades av FDA 22 januari 2013.

Läs dokumentet här

Current Challenges in Implementing Quality Risk Management

En ny artikel från James Vesper och Keven O’Donnell publicerad i Pharmaceutical Engineering, Nov-Dec 2016.
Ur innehållet::
"The intent of QRM is to make data-driven and scientifically sound decisions proactively, not to justify an action or a decision that has already been taken"
"Formal risk assessments sometimes fail to add value or clarity to a situation because risk assessments often only superficially address root cause analysis, resulting in ineffective risk-control actions"
"Some firms have not yet seen that hazard identification and risk assessment tools can be used together synergistically"

Läs mer

Relaterad kurs: "Quality Risk Management - Applying the principles and tools", May 8-9, 2017, Copenhagen, Denmark