From Site to First Batch

Compliance is cheapest when it is designed in.
Building a pharmaceutical plant is one of the largest quality decisions a company will ever make.From Site to First Batch takes you from site selection to the first commercial batch of a non-sterile plant making tablets and capsules, creams and ointments, and liquid medicines. It joins what is usually taught apart: utilities, GMP, equipment, process, qualification and the people who must run it.
Written for investors, project directors, engineers, quality and production leaders, consultants and students, the book follows one illustrative Reference Plant from concept to launch, so every chapter builds on the last.
Inside you will find:

Strategy and licensing: build, buy or contract; stage gates; the regulatory landscape (SAHPRA, WHO, PIC/S, EU, FDA)
GMP by design: pharmaceutical quality system, quality risk management, zoning, flows, airlocks and cross-contamination control
Utilities: HVAC, purified water, steam, compressed air, power, effluent and fire protection

Equipment and process: unit operations and layouts for oral solids, semi-solids and liquids, plus packaging and warehousing
Qualification and validation: DQ/IQ/OQ/PQ, process and cleaning validation, computerised systems, the QC and microbiology laboratory
Humana capital: organisation design, a headcount build-up, recruitment, training and quality culture
Implementation guides in every chapter: phased steps, owners, deliverables and checklists
Inspection-ready from day one: every PIC/S Aide-moire converted into "show me" evidence tables (Appendix J)
Appendices: 36-month programme plan, URS skeleton, room data sheets, qualification protocol outlines, a 150-item SOP list, training matrix, inspection readiness checklist, regulatory map and glossary

South Africa is the worked regulatory example, with comparisons to WHO, PIC/S, EU and US expectations so the method travels to your market.

About the author: Dr Legohu Mogodi, DBA, is a Johannesburg-based consultant with more than 30 years in quality management, governance, regulatory compliance and operational excellence. A lead auditor for ISO 9001, 45001 and 50001, he has implemented quality systems in plants to PIC/S and WHO GMP standards and served as Strategic Performance and Governance Specialist at SAHPRA.