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Guidance for SMEs using ISO 9001 for quality management just released

ISO’s essential guide for SME’s wishing to implement a quality management system (QMS) has just been updated, providing practical advice and concrete examples tailored specifically for small businesses.

ISO 9001:2015 for Small Enterprises  What to do? has just been updated to align with the newly revised version of one of ISO’s most popular standards, ISO 9001, Quality management systems – Requirements, updated in 2015.

The handbook was written by a group of experts from ISO/TC 176/SC 2, the technical subcommittee that developed ISO 9001:2015, and features useful information on everything from how to get started right through to guidance for those who choose to seek certification. It includes practical advice on the different ways of approaching a quality management system (QMS) as well as detailed guidance on each element of ISO 9001:2015.

Nigel Croft, Chairman of ISO/TC 176/SC 2, said: “This handbook recognizes that small businesses have different needs and challenges compared to large organizations, with different ways of working and often with limited resources. This handbook offers tailored advice to help them implement a quality management system that can truly be useful, and help them to improve their overall business performance.”


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ICH Advances Three Guidance Documents

The International Council for Harmonisation (ICH) earlier this week announced the advancement of two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.


ICH E6(R1): Guideline for Good Clinical Practice (GCP) advanced

CH Q3C(R6) Guideline advanced and it revises the permissible daily exposure (PDE) for methyl isobutyl ketone (MIBK), and adds triethylamine (TEA) as a new solvent.

ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)

For the full story read it here at

Source: Regulatory Affairs Professionals Society

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Transition plan from Article 57/XEVMPD data submission to SPOR

In the context of the implementation of the ISO IDMP standards, the European Medicines Agency (EMA) is establishing services to support the management of master data, i.e. substance, product, organisation and referential (collectively referred to as ‘SPOR’) data. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards. The phased implementation plan envisages the prioritisation of the ‘Referentials’ and the ‘Organisation’ management services (RMS and OMS) in 2016 with the view of making them available in 2017. This document is a preliminary communication on the foreseen transition from the current Article 57 processes to the ‘to be’ SPOR processes. It is aimed at clarifying the change management plan for the provision of information related to the referential and organisation entities, currently managed via the eXtended EudraVigilance Product Report Message (XEVPRM) format, within the OMS and RMS requirements. This document also includes the process change for submissions of approved substance information to the Agency. The requirements will apply to the marketing authorisation holders (MAHs) and sponsors of clinical trials currently submitting data in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD). The processes and technology for the EMA and the relevant stakeholders to enable the registration and maintenance of the master data are currently being established, and will be communicated to all stakeholders once available.

Source: European Medicines Agency

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Simpler website navigation for regulatory information on human medicines

New navigation to help users find information more easily

The European Medicines Agency (EMA) has simplified the navigation structure of the regulatory information on human medicines on its website, to help users from pharmaceutical companies find the information they need more quickly and easily.

EMA took action based on detailed feedback from a diverse range of industry stakeholders who use the EMA website for different purposes, and reorganised the navigation accordingly.

The new menu reflects the three main stages of the medicinal product lifecycle, because most industry users said they prefer to look for information on medicines regulation in this way.

Source: European Medicines Agency

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Implementation of ISO IDMP standards

The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies.

For the full story visit

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New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines

The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine.

European Medicines Agency


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