Booklets

Customized GMP collection booklets

If none of our standard combinations of regulations and languages suits you need, why not configure your own GMP pocket guide.

Any combination of the below regulations can be combined into your own customized GMP pocket guide. Translations can be offered separately or in parallel with the original text.

The only limitation is the amount of material you want us to put into your customized guide. The booklets will be provided in two formats:
93x155 mm (Max 190 pages)
110x170 mm (Max 250 pages)

The booklets are wire-bonded for easy handling.

Minimum order quantity is 100 booklets and normal delivery from approved configuration is 3 weeks.

Fill in the form below for a quotation on your customized GMP pocket booklet.
If you wish a translation in parallel with the english text, mark both EN and the other language.

Regulation (by industry/area)

Languages

General regulations

 

21 CFR Part 11
Electronic Records; Electronic Signatures

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Combination products

 

21 CFR Part 4
Regulation of Combination Products

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Pharmaceuticals

 

21 CFR Part 210
Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs; General

21 CFR Part 211
Current Good Manufacturing Practice for Finished Pharmaceuticals

EU Guidelines for GMP, Part I
Medicinal Products for Human and Veterinary Use

EU Guidelines for GMP, Part II
Basic Requirements for Active Substances used as Starting Materials

EU Guidelines for excipients 2015/C 95/02

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EU Guidelines for GMP, Annexes

 

1  Manufacture of Sterile Medicinal Products

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2  Manufacture of Biological active substances and Medicinal Products for Human Use

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8  Sampling of Starting and Packaging Materials

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11  Computerised Systems

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13  Manufacture of Investigational Medicinal Products

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15  Qualification and validation

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16  Certification by a Qualified person and Batch Release

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17  Parametric Release

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19   Reference and Retention Samples

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Glossary

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Medical Device

 

21 CFR Part 820
Quality System Regulation (Medical Devices)

Distribution

 

EU GDP Guidelines 2013/C 343/01

Guidelines on Good Distribution Practice of Medicinal Products for Human Use

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EU Excipients GDP Guidelines 2015/C 95/01

Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use

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LVFS 2014:8
Läkemedelsverkets föreskrifter om partihandel med läkemedel

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Quantity (min 100 pcs):

 

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