核心服務
為製藥和生物技術設施提供全面的GMP工程和諮詢解決方案
GMP
設施設計
從概念到詳細設計，確保符合 PIC/S GMP 和 FDA 法規。
細胞療法
設施
為先進治療設備製造提供專業設計和工程服務。
電腦系統
驗證
符合 FDA 21 CFR 第 11 部分規定的關鍵製造系統驗證。
擁有者
代表
在設施的整個生命週期內，提供全面的專案監督和管理，以保護您的利益。
為什麼選擇Persimmon Engineering
Deep Industry Expertise
Two decades of hands-on experience in GMP facility engineering and owner representation.
Proven Track Record
Successfully delivered 600+ projects for leading pharmaceutical and biotech companies.
Local & Global Presence
Taiwan-based with international offices, combining local market knowledge with global best practices.
Flexible Resources
Scalable team structure to support projects of any size and complexity.
趨勢與洞察
GMP regulations and pharmaceutical engineering
Master the regulatory framework, essential qualifications, and organizational duties for a Good Distribution Practice (GDP) Responsible Person.
A comprehensive guide to maintaining pharmaceutical supply chain integrity, regulatory compliance, and robust quality management systems.
Navigate European and international GMP regulations for biotechnological products, focusing on process control, virus safety, and inherent variability.
Explore the mechanisms of stainless steel oxidation, rouging classifications, and actionable lifecycle management strategies to ensure GMP compliance in your pharmaceutical facility.
Prepare for the EMA's new 3-year work plan including updates to Annex 15, Annex 22, and key GMP chapters.
An in-depth analysis of Simtra BioPharma's CGMP violations, highlighting risks from equipment dead legs, failed CAPA, and systemic contamination.
Discover key GMP violations from the recent FDA Warning Letter to OraLabs Inc. Learn why rigorous Root Cause Analysis is critical for compliance.
An Indian lab faces FDA action for systemic data destruction, backdated records, and inspection obstruction. See how this impacts CGMP compliance.
Navigate the regulatory shift towards patient-centric quality attributes for autologous cell and gene therapies with expert insights.
How ignored Performance Qualification (PQ) failures and systemic dead legs in pharmaceutical water systems led to an FDA Warning Letter.