Welcome to the Blood forum. This forum has been created by the Medicines and Healthcare products Regulatory Agency (MHRA) as a tool to help all those involved in blood component collection, processing, testing and distribution to comply with the EU Blood Directives, UK Statutory Instruments and good practice requirements.
Many professionals within the blood component community frequently seek advice from the MHRA, relating to various issues, including the MHRA interpretation of the current regulations and guidelines.
In most circumstances, the GMDP inspectors can address these queries however, in order to remain unbiased and independent, inspectors cannot instruct organisations on the best approach to take to meet these requirements. This Blood online discussion forum provides the ideal opportunity for extended communication between interested parties and allows users to put forward their comments and examples of how they meet the legislative requirements. This will then give users, real-life, examples of ways in which they can manage robust quality procedures that ensure compliance and which dovetail with their own business needs and resources.
However, we welcome lively discussion on this site, but ask you to please bear in mind our guidelines when submitting comments.
We pre-moderate all comments submitted to this site. This means that comments will not be published instantly; as they will first be checked by moderators. Moderators will be monitoring the site every day between 10am and 4pm on working days, and aim to process comments within 24 hours of receipt. Comments added over the weekend or bank holidays will be moderated on the first subsequent working day. All comments will be processed within 72 hours.
The aim is to ensure the discussions are accurate, inclusive, relevant and constructive. We will normally approve comments for publication as long as they:
- respect other people. Comments should not be malicious or offensive in nature, and should not constitute a personal attack on a person's character
- don't incite hatred on the basis of race, religion, gender, nationality or sexuality or other personal characteristic
- don't include swearing, hate-speech or obscenity
- don't reveal personal details, such as private addresses, phone numbers, email addresses or other online contact details
- don't break the law, this includes libel, condoning illegal activity, and breaking copyright
- are reasonably concise, and don't constitute spamming of the site
- don't advertise commercial products and services
- don't impersonate or falsely claim to represent a person or organisation
- are in English, unfortunately, we do not currently have the resource to moderate comments in other languages
- are on-topic. Please don't post messages that are unrelated to this channel
- are not party political in nature. This is a Government website and comments used for party political purposes cannot be published for propriety reasons.
We reserve the right to suspend comments at any time. Where we choose not to publish a comment for any reason we will reply to the commenter by email explaining our reason and inviting them to make appropriate changes so that the comment can be reconsidered.
This is not about censoring your views. The aim is to ensure that comments relate to the particular subject being discussed. Moderation will not be used to suppress legitimate, reasoned discussion.
The primary focus for the forum is to allow organisations and individuals to ask about and share best practice. This forum should not be used for the following, as formal routes are already in place to deal with these types of communications:
- specific questions directed to the GMDP inspectorate. These should be sent to firstname.lastname@example.org *
- notification of serious adverse events or reactions which should continue to be reported to email@example.com
- complaints (these should be directed via the standard MHRA complaints procedure, described on the MHRA website).
If you have a query about why your contribution has not appeared on the site or our approach to moderation, please contact us at firstname.lastname@example.org
MHRA officers endeavour to ensure that advice and comments offered reflect MHRA operational inspectorate policy and a science and risk based approach to the matters raised. You should note that any technical or regulatory advice given to you is not legally binding with regard to any future application(s) for the concerned site or products manufactured therein, neither on the part of MHRA nor on the company. Furthermore, advice cannot be taken as indicative of any future agreed position during inspection.
The answers given by MHRA are based on the questions and documentation submitted and cannot account for future changes and developments in scientific knowledge or regulatory requirements. Companies should note that the advice provided is without prejudice to applicable legislation relating to the particulars and documents which should be submitted in support of any Blood Establishment Authorisation (or other) Application; it is also without prejudice to any intellectual property rights of third parties. It is possible that during inspection further considerations may come to light that may alter the advice given.