Medicines and Healthcare products Regulatory Agency

Issued following an inspection in accordance with :

Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

  The competent authority of United Kingdom confirms the following :    

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. UK MIA(IMP) 48101 in accordance with Part 6 of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 15/11/2022, it is considered that it complies with

• The principles and guidelines of Good Manufacturing Practice laid down in Regulation B17 of the Human Medicines Regulations 2012 (as amended)

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. This certificate is valid only when presented with all pages and both Parts 1 and 2. The authenticity of this certificate may be verified in MHRA-GMDP. If it does not appear, please contact the issuing authority.

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Operations

1. MANUFACTURING OPERATIONS

[ 1.1 ] Sterile Investigational Medicinal Products

[ 1.1.1 ] Aseptically prepared (processing operations for the following dosage forms)

[ 1.1.1.1 ] Large volume liquids

[ 1.1.1.4 ] Small volume liquids

[ 1.1.1.6 ] Other aseptically prepared products Manipulation of previously formulated products e.g. cytotoxics and monoclonal antibodies, GMOs and vaccines.

[ 1.1.3 ] Batch certification

[ 1.2 ] Non-sterile investigational medicinal products

[ 1.2.1 ] Non-Sterile Products (processing operations for the following dosage forms)

[ 1.2.1.1 ] Capsules, hard shell

[ 1.2.1.6 ] Liquids for internal use

[ 1.2.1.8 ] Other solid dosage forms

[ 1.2.1.17 ] Other non-sterile medicinal products Weighing and mixing of drug substance into individual subject dose containers

[ 1.2.2 ] Batch certification

[ 1.4 ] Other products or manufacturing activity

[ 1.4.2 ] Sterilisation of active substances/excipients/finished products:

[ 1.4.2.1 ] Filtration

[ 1.5 ] Packaging

[ 1.5.1 ] Primary packaging

[ 1.5.1.1 ] Capsules, hard shell

[ 1.5.1.2 ] Capsules, soft shell

[ 1.5.1.5 ] Liquids for external use

[ 1.5.1.6 ] Liquids for internal use

[ 1.5.1.8 ] Other solid dosage forms

[ 1.5.1.11 ] Semi-solids

[ 1.5.1.13 ] Tablets

[ 1.5.1.17 ] Other non-sterile medicinal products Weighing and mixing of drug substance into individual subject dose containers

[ 1.5.2 ] Secondary packaging

[ 1.6 ] Quality control testing

[ 1.6.3 ] Chemical/Physical

Contact Details

15/11/2022	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential