Medicines and Healthcare products Regulatory Agency

Issued following an inspection in accordance with :

Regulation 331A of The Human Medicines Regulations 2012 (SI 2012/1916)

  The competent authority of United Kingdom confirms the following :    

Has been inspected in connection with marketing authorisation(s) listing manufacturers located outside of the European Economic Area in accordance with Part 16 of The Human Medicines Regulations 2012 (SI 2012/1916)

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 16/05/2016, 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 Products

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

[ 1.1.1.2 ] Lyophilisates

[ 1.1.1.4 ] Small volume liquids

[ 1.1.2 ] Terminally Sterilised (processing operations for the following dosage forms)

[ 1.1.2.2 ] Semi-solids

[ 1.1.2.3 ] Small volume liquids

[ 1.2 ] Non-sterile products

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

[ 1.2.1.5 ] Liquids for external use

[ 1.2.1.6 ] Liquids for internal use

[ 1.2.1.11 ] Semi-solids

[ 1.2.1.12 ] Suppositories

[ 1.2.1.17 ] Other non-sterile medicinal products Suspensions, Nasal Sprays sprays (pump liquid type not metered dose inhalers which are pressurised)

[ 1.3 ] Biological medicinal products

[ 1.3.1 ] Biological medicinal products

[ 1.3.1.2 ] Immunological products

[ 1.3.1.8 ] Other biological medicinal products Immunoglobulin derived from horse serum both as a bulk API lyophilised and is then making the finish

[ 1.4 ] Other products or manufacturing activity

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

[ 1.4.2.1 ] Filtration

[ 1.4.2.2 ] Dry heat

[ 1.4.2.3 ] Moist heat

[ 1.4.3 ] Other Super critical fluid carbon dioxide sterilisation

[ 1.5 ] Packaging

[ 1.5.2 ] Secondary packaging

[ 1.6 ] Quality control testing

[ 1.6.1 ] Microbiological: sterility

[ 1.6.2 ] Microbiological: non-sterility

[ 1.6.3 ] Chemical/Physical

[ 1.6.4 ] Biological

Contact Details

07/12/2016	Name and signature of the authorised person of the Competent Authority of United Kingdom
	Confidential
	Medicines and Healthcare products Regulatory Agency
	Tel : Confidential