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BSI DD 264:2007

BSI DD 264:2007

$102.76

Packaging. Braille and other formats for medicinal products

Published By Publication Date Number of Pages
BSI 2007 24
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PDF Catalog

PDF Pages PDF Title
3 Contents
1 Scope 1
2 Terms and definitions 1
3 General requirements for medicinal product packaging 2
4 Product identification and legibility of labelling 4
Annexes
Annex A (informative) Package leaflet alternative formats 5
Annex B (informative) Alternative package leaflet formats, critical control points 6
Annex C (informative) Braille characteristics and recommendations 7
Annex D (informative) Braille critical control points 8
Annex E (informative) Braille character sets 11
Annex F (normative) Braille verification 11
Annex G (informative) Technology for the application of Braille to packaging for medicinal products 12
Annex H (informative) Braille specifications and artwork generation 15
Bibliography 17
List of figures
Figure C.1 – The Braille cell 7
Figure C.2 – Braille text representation 8
Figure C.3 – Marburg medium spacing convention for Braille 8
Figure E.1 – Braille transposition of letters in common use 11
Figure G.1 – Principle of embossing 12
Figure G.2 – Example of Braille positioning on a carton 13
Figure H.1 – Approved artwork proof 16
List of tables
Table B.1 – Alternative package leaflet formats, critical control points 6
Table D.1 – Braille artwork/origination 9
4 Foreword
5 1 Scope
2 Terms and definitions
2.1 audit trail
2.2 Braille
2.3 Braille cell
2.4 Braille character set(s)
2.5 burst-through
2.6 contracted Braille grade 2 Braille
2.7 job bag
6 2.8 line clearance
2.9 Marburg medium spacing convention
2.10 marketing authorization holder (MAH)
2.11 package leaflet (PL) patient information leaflet (PIL)
2.12 quality assurance (QA)
2.13 quality control (QC)
2.14 uncontracted Braille grade 1 Braille
3 General requirements for medicinal product packaging
3.1 Braille spacing convention
7 3.2 Braille character sets
3.3 Braille dot height
a) For embossed materials the minimum dot height shall be no less than 0.12 mm in accordance with F.1.
b) For other Braille production methods the minimum dot height shall be no less than 0.20 mm in accordance with F.1.
8 4 Product identification and legibility of labelling
4.1 Product identification
a) trade mark or generic name of the product, as appropriate;
b) the strength of the product (where more than one is available);
c) the dosage form of the product, e.g. tablet, capsule, solution, where more than one dosage form is available.
4.2 Braille text legibility
4.3 Printed text legibility
9 Annex A (informative) Package leaflet alternative formats
A.1 Legislated requirement
A.2 General issues
a) Braille;
b) large print;
c) audio;
d) electronic text.
10 Annex B (informative) Alternative package leaflet formats, critical control points
Table B.1 Alternative package leaflet formats, critical control points
11 Annex C (informative) Braille characteristics and recommendations
C.1 Braille character sets
C.2 The Braille cell
Figure C.1 The Braille cell
12 Figure C.2 Braille text representation
C.3 Marburg medium spacing convention for Braille
Figure C.3 Marburg medium spacing convention for Braille
Annex D (informative) Braille critical control points
13 Table D.1 Braille artwork/origination
14 Table D.1 Braille artwork/origination (continued)
15 Annex E (informative) Braille character sets
Figure E.1 Braille transposition of letters in common use
Annex F (normative) Braille verification
F.1 Braille height measurement
16 F.2 Product identification by Braille legibility testing
Annex G (informative) Technology for the application of Braille to packaging for medicinal products
G.1 General
a) embossing (see G.2);
b) screen printing (see G.3);
c) other production methods, e.g. thermally-reactive inks (see G.4).
G.2 Embossing
Figure G.1 Principle of embossing
17 Figure G.2 Example of Braille positioning on a carton
18 G.3 Screen printing
G.4 Other production methods
G.4.1 General
G.4.2 Containers with integral Braille
G.4.3 Adhesive labels
G.5 Packaging supplier controls
G.5.1 Identification of Braille tooling
G.5.2 In-process controls
19 G.6 MAH incoming supplies checks
a) the accuracy of the Braille translation and application, i.e. conformance to specification and artwork requirements;
b) the position/location of the Braille on the packaging material (see G.2);
c) ensuring that all printed text remains legible for sighted people (see 4.3);
d) the quality of the Braille text is to specification (see 3.3 and F.1).
Annex H (informative) Braille specifications and artwork generation
20 Figure H.1 Approved artwork proof
21 Bibliography
[1] EUROPEAN COMMUNITIES. 2004/27/EC. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amendi…
[2] EUROPEAN COMMUNITIES. 2001/83/EC. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on t…
[3] GREAT BRITAIN. Guidance concerning the Braille requirements for labelling and the package leaflet. Article 56a as amended. ENTR/F2 D(2005) European Commission.
[4] GREAT BRITAIN. The Medicines (Marketing Authorisations Etc.) Amendment Regulations 2005 – SI 2005 No. 2759.
[5] GREAT BRITAIN. The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 – SI 2005 No. 2789.
[6] GREAT BRITAIN. Marburg medium spacing convention http://www.tiresias.org/
[7] GREAT BRITAIN. GAMP Forum Steering Committee. Good Automated Manufacturing Practice (GAMP). USA: ISPE. ISBN: 1 931879 22 2 http://www2.ispe.org
[8] http://www.mhra.gov.uk/home
[9] EUROPEAN COMMISSION. EU Common Technical Document, Notice to Applicants Vol 2B, June 2006, Module 1.3.6 page 15 http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/ b/ctd_06-2006.pdf

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BSI DD 264:2007
$102.76