CASE STUDY
Pharmaceutical Formulation Plant Kabul Case Study
General & Cephalosporin Products
Life Pearl Pharmaceutical
Kabul, Afghanistan | 2020 – 2022
Project Overview
JD Pharma & Consultant was engaged by Life Pearl Pharmaceutical to deliver comprehensive engineering design services for the development of a new pharmaceutical formulation plant located in Kabul, Afghanistan. The project encompassed both a General Formulation section and a dedicated Cephalosporin section, with the facility designed and documented in full compliance with WHO-GMP regulatory standards.
The plant was developed as a greenfield facility, with the engineering design phase spanning 2020 to 2022. The project represents a significant milestone in advancing pharmaceutical manufacturing capabilities in Afghanistan and contributes directly to improving access to quality medicines in the region.
2 Years
Project Duration
150 kg
Granulation Capacity
1,500 L
Liquid Capacity
WHO-GMP
Regulatory Standard
Project Snapshot
Project Title | Pharmaceutical Formulation Plant — General & Cephalosporin Products |
Client | Life Pearl Pharmaceutical, Kabul, Afghanistan |
Project Type | Greenfield Pharmaceutical Manufacturing Facility |
Location | Kabul, Afghanistan |
Project Start | 2020 |
Project Completion | 2022 |
Duration | Approximately 2 Years |
Regulatory Standard | WHO-GMP (World Health Organization Good Manufacturing Practices) |
Services Provided | Engineering Design |
Project Status | Successfully Completed |
Product Portfolio & Capacity
Product Dosage Forms
General Formulation | Tablet, Capsule, Liquid Oral |
Cephalosporin Section | Dry Syrup, Capsule |
Manufacturing Capacity
Granulation Capacity | 150 kg per batch |
Liquid Manufacturing Capacity | 1,500 Liters per batch |
Engineering Design Services Provided
JD Pharma & Consultant delivered a full suite of pharmaceutical engineering design services covering facility layout, HVAC, utilities, containment, and regulatory documentation. The scope of engineering services is detailed below:
| Engineering Area | Description of Services |
01 | GMP-Compliant Facility Layout & Zoning | Developed a GMP-compliant architectural layout segregating General Formulation and Cephalosporin manufacturing zones with dedicated airlocks, change rooms, and material transfer hatches to prevent cross-contamination. Defined clean room classifications (ISO Class 7 & 8) aligned with WHO-GMP requirements. |
02 | HVAC & Cleanroom Design (AHU System) | Designed the HVAC system including Air Handling Units (AHUs), return air ducts, HEPA filtration (H13/H14), pressure differentials, and temperature/humidity controls for each zone. Separate, dedicated HVAC systems were designed for the cephalosporin section to maintain containment and avoid cross-contamination. |
03 | Process Flow & Material Flow Engineering | Established unidirectional material and personnel flow diagrams to eliminate cross-contamination risks. Process flow from raw material receipt, in-process manufacturing, packaging, to finished goods dispatch was engineered in compliance with GMP guidelines. |
04 | Equipment Selection & Layout Design | Provided engineering input for selection and placement of key process equipment including: Granulation equipment (150 kg capacity — rapid mixer granulator, fluid bed dryer), Liquid oral manufacturing equipment (1,500 L capacity — SS tanks, homogenizer, filling lines), Tablet compression, coating, and capsule filling machines, Dry syrup blending and filling equipment for cephalosporin section. |
05 | Utility System Design | Designed utility systems including Purified Water (PW) generation & distribution (loop system), Water for Injection (WFI) system (where applicable), Compressed air system (oil-free), Clean steam and process steam systems, and Electrical load planning & distribution layout. |
06 | Containment Engineering for Cephalosporin Section | Engineered a fully dedicated, self-contained cephalosporin manufacturing wing with separate entry/exit, dedicated gowning, negative pressure rooms, and independent utilities to prevent beta-lactam contamination of the general formulation area. |
07 | Quality & Safety Systems Design | Incorporated environmental monitoring points, drain slope and cleanability requirements, and wash-in-place (WIP) provisions. Fire safety and emergency exit planning were integrated into the building design per local and international codes. |
08 | Documentation & Engineering Deliverables | Prepared a comprehensive set of engineering deliverables including: Architectural & layout drawings (GMP zoning plans), P&ID (Piping and Instrumentation Diagrams), HVAC layout and AHU schedule, Equipment list and URS (User Requirement Specifications), Utility flow diagrams, Room data sheets with classification, pressure, and finish specifications. |
09 | Regulatory Compliance & WHO-GMP Alignment | All engineering designs were developed in strict compliance with WHO Technical Report Series (TRS) GMP guidelines applicable to pharmaceutical manufacturing, ensuring the facility design is audit-ready for WHO-GMP inspection and pre-qualification. |
Regulatory Compliance Framework
The entire facility design was executed in conformance with WHO Good Manufacturing Practices (GMP) as outlined in the WHO Technical Report Series. Key compliance aspects integrated into the engineering design include:
- Premises & Equipment Design per WHO-GMP Part 3 & Part 4
- Air quality, pressure differentiation, and environmental controls per WHO TRS standards
- Dedicated containment for beta-lactam (Cephalosporin) manufacturing
- Documentation systems aligned with WHO-GMP requirements for design qualification (DQ)
- Cross-contamination prevention measures embedded at engineering level
- Unidirectional personnel and material flow to maintain GMP hygiene standards
Project Outcome & Value Delivered
The engineering design services delivered by JD Pharma & Consultant enabled Life Pearl Pharmaceutical to develop a technically robust, GMP-compliant pharmaceutical plant capable of manufacturing a wide range of oral solid dosage forms and liquid products. Key outcomes include:
- A fully functional General Formulation section producing tablets, capsules, and liquid orals
- A dedicated Cephalosporin section for dry syrup and capsule manufacturing with complete containment
- Engineering drawings and documentation suitable for regulatory inspection and WHO pre-qualification activities
- A scalable facility design allowing for future capacity enhancement
- Significant enhancement to local pharmaceutical manufacturing capability in Afghanistan
About JD Pharma & Consultant
JD Pharma & Consultant is a specialized pharmaceutical engineering consultancy providing end-to-end design, regulatory, and project management services to the global pharmaceutical and biotechnology industry. Our capabilities span GMP facility design, HVAC and cleanroom engineering, utility systems, validation support, and regulatory documentation — all tailored to meet WHO, EU-GMP, US-FDA, and other international standards.
For project inquiries and further information, please contact us:
JD Pharma & Consultant
Pharmaceutical Engineering & Consultancy Services
