WHO Good Manufacturing Practices
Quality-system and manufacturing-practice reference for pharmaceutical products and facilities, as applicable to the relevant WHO guidance and national requirements.
WHO standards & guidance ↗Quality-led project approach
Quality & Regulatory Reference Frameworks
Reference standards that may be relevant to pharmaceutical manufacturing facilities, controlled environments, quality systems, qualification and calibration assignments.
Important: The frameworks below are shown as technical references only. Their applicability depends on the product, process, market, facility design and scope of work. Listing a standard does not mean SHAN or any client site is certified, approved, accredited, inspected or endorsed by the issuing authority.
Revised Schedule M
Indian Drugs Rules GMP requirements; site-specific gap assessment, documentation and implementation planning should be checked against the current notified requirements.
CDSCO official portal ↗EU GMP Guide
European GMP guidance may be relevant where the product, market, licence or customer quality agreement requires it.
EudraLex Volume 4 ↗US FDA cGMP
US regulatory requirements and guidance may apply to products manufactured for, or supplied into, the United States market.
FDA cGMP resources ↗Cleanrooms & Controlled Environments
Cleanroom classification and related controlled-environment practices may be used when defining facility and qualification requirements.
ISO 14644-1 reference ↗Testing & Calibration Laboratories
Competence requirements for testing and calibration laboratories; accreditation status must be independently verified for the selected provider.
ISO/IEC 17025 overview ↗Project-specific compliance
Requirements are confirmed before execution
For each enquiry, the applicable standards, deliverables, acceptance criteria, responsibilities and evidence requirements should be agreed in writing. Final compliance decisions remain with the responsible manufacturer, site management and applicable regulatory authorities.
Scope and gap assessment
Risk-based documentation planning
Qualification & validation coordination
Evidence and report review support
