Regulatory library
EU GDP Guidelines 2013/C 343/01
The EU guidelines on good distribution practice. For equipment they ask that storage areas be temperature mapped before use, that monitoring devices be calibrated, that alarms be tested and that computerized systems be validated.
ValDoc's library holds 7 provisions of EU GDP Guidelines 2013/C 343/01. This page is guidance in our words. The regulation's own text governs.
Last updated
Thirty minutes. Bring one piece of equipment.
Provisions in ValDoc's library
EU GDP Guidelines 2013/C 343/01
Effective
Guidelines on Good Distribution Practice of medicinal products for human use
EU GDP 2013/C 343/01 §3.2.1
Effective
EU GDP 2013/C 343/01 §3.3
Effective
EU GDP 2013/C 343/01 §3.3.1
Effective
EU GDP 2013/C 343/01 §3.3.2
Effective
EU GDP 2013/C 343/01 §§5.2-5.3, 6.3, 7.1-7.3
Effective
EU GDP 2013/C 343/01 §§9.1-9.4
Effective
Other regulations
- ATEX Directive 2014/34/EU
- Directive 2000/54/EC
- EMA GMP questions and answers: nonsterile manufacture
- EMA Guideline on process validation for finished products
- EudraLex Volume 4
- EudraLex Volume 4, Annex 1
- EudraLex Volume 4, Annex 2
- EudraLex Volume 4, Annex 11
- EudraLex Volume 4, Annex 13
See your own equipment in ValDoc.
Bring one piece of equipment, or one you plan to buy, and we’ll walk it through ValDoc with you, from its intended use to the signed record.
Thirty minutes. Bring one piece of equipment.