"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"


Other languages:   

The New EU MDR and IVDR regulations as E-books (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.
- Always available in your phone, tablet or computer
- Easy to search in the text
- Linked Table of Contents

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).

Read the EC Press release     Download the guideline


/ Consulting

Key2Compliance AB has started a collaboration with Symbioteq Kvalitet AB during spring 2017, where Symbioteq will work more actively to strengthen our range of training within Medtech and several of Symbioteq's consultants will reinforce as trainers.

Symbioteq will no longer organize training courses and will focus entirely on consulting and broadening its range of consulting services from Medtech to Pharmaceuticals and the entire Life Science sector.

"We are convinced that cooperation will ensure that customers’ need are met even better for quality support and quality education and training through greater accessibility to a wide range of services in the area," said Key2Compliance® chairman Anna Lundén.

As part of the company's long-term strategy to become Northern Europe's premium suppliers of specialist services in quality assurance and regulations for the pharmaceutical and medical device industry, Symbioteq Kvalitet AB has also acquired shares in Key2Compliance AB.

Read more about our consulting services

The new medical device/in-vitro diagnostic regulations are finally adopted in 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.

Read the EC Press release

Block 22 May 10.00-11.30 and 7 June 15.00-16.30 for our Webinar presenting the news and essentials.   https://www.key2compliance.com/cs5002.php


From the MHRA Inspectorate blog:
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.

Read the blog

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®.

Final Guidance on CGMP Requirements for Combination Products published

The draft document was issued January 2015 and is now published as final. This guidance describes and explains the final rule on current good manufacturing requirements for combination products (21CFR4) that FDA issued on January 22, 2013.

Read More

Current Challenges in Implementing Quality Risk Management

New article from James Vesper and Keven O’Donnell published in Pharmaceutical Engineering, Nov-Dec 2016.
From the content:
"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"

Read More

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