CPSG – Documentation
BRAM-COR GMP REFERENCE STANDARDS
(data realease of the following list can change without notice, Bram-Cor always works with up-to-date certifications)
- United States Pharmacopoeia (USP)
- European Union Pharmacopoeia (EP)
- EudraLex – The Rules Governing Medicinal Products in the European Union – Vol. 4: Good Manufacturing Practice-Medicinal Products for Human and Veterinary Use
- Sterile Manufacturing facilities – ISPE Guideline
- Water & steam systems – European Pharmacopoeia current edition USP – ISPE Guideline
- Testing GXP – ISPE Guideline
- Commissioning and Qualification , Vol.5 – ISPE Guideline
- Commissioning and Qualification of Water and Steam Systems, current edition – ISPE Guideline
- Approaches to Commissioning and Qualification of Water and Steam Systems – ISPE Guideline
- Calibration Management, current edition – ISPE Guideline
- 2006/42/CE European Directive for Machinery, current edition
- 2014/68/UE Eur. Directive for Pressure Vessels (repl. PED 97/23/CE)
- ASME BPVC Boiler and Pressure Vessel Code – S / U stamp certified
- GAMP 5: “A risk-based approach to compliant GXP computerized systems”
- CFR 21 Part 11: FDA guideline for electronic records and electronic signatures
- ASME BPE “Bioprocessing Equipment”
- UNI EN 9606:2013 – “Qualification of welders” – Manual welding
- UNI EN 14732:2013 “Qualification of welders” – Automatic welding
- A270 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing
- A269 ASTM – “Standard Specification for Seamless and Welded Austenitic Stainless Steel Tubing for General Service
- A479 ASTM “Standard Spec. for Stainless Steel Bars and Shapes for Use in Boilers and Other Pressure Vessels”
- A967 ASTM – “Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts”
- CEI EN 60204-1:“Electrical safety of machinery”
- IEC 1131-1: “Programmable Controllers – General Information”
- UNI 10893: “Technical Documentation of Product”
- UNI EN 10204: “Metallic products – type of inspection documents”
- ASTM C-795 “Standard Specification for Thermal Insulation for Use in Contact with Austenitic Stainless Steel”
- UNI 5634 “Identification of piping for fluids”
- ASTM A380 “Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment and Systems”
- EN 285 “Sterilization, steam sterilizers, large sterilizers (related to Bram-Cor CPSG/Pure Steam Generator)