Regulations & Guidelines
Standards We Follow!
GMP Standards
GMP: USFDA, EU, BP, WHO, PIC/S, MHRA, cGMP, EHEDG, FDA, ASME (BPE), A 3, ISPE Baselines, ISO – 14159
Piping Standards
Process: (BPE) / SA 270 & Utility: ANSI B 31.3
Automation Standards
Automation:GAMP5 & 21 CFR Part 11
Qualification Documents & Execution Standards
QD-ES: ISPE Baselines Vol 5
Mechanical Standards
Vessels: ASME Sec. VIII Div.1, AD – Merkblatt, ASME BPE & Heat Exchangers: TEMA
European Nations Standards
NDT Standards: EN – 1435, 895, 12517 & 571 & Safety Standards: DS/EN 1050 & Hygienic Design: B3 EN 1672 – 2
