From URS to PQ Sign-Off
Turnkey Pharmaceutical Packaging Solutions
HIJ Machinery delivers complete pharmaceutical packaging turnkey lines — from equipment selection and URS execution through factory acceptance testing, on-site installation, and final performance qualification sign-off. One partner. Full compliance. 30+ countries served.
- European-quality equipment at 30–40% below EU pricing
- WHO GMP / cGMP / 21 CFR / CE — full compliance
- Complete DQ/IQ/OQ/PQ validation documentation
- Single point of responsibility — URS to handover
- Global on-site installation and commissioning
Quick Facts
Delivery
16–26 wks
Origin
Wenzhou, CN
Markets
30+ countries
Validation
DQ–PQ incl.
Response
24 hours
WHO GMP
cGMP
CE
21 CFR
What Is a Turnkey Pharmaceutical Line
Turnkey Pharmaceutical Packaging Solutions: Definition & Scope
A turnkey pharmaceutical packaging solution is a complete end-to-end equipment project in which a single supplier is responsible for equipment design, procurement, manufacturing, factory acceptance testing (FAT), delivery, on-site installation, commissioning, operator training, and qualification documentation (DQ/IQ/OQ/PQ) — from initial User Requirement Specification (URS) through final Performance Qualification sign-off.
HIJ Machinery (Wenzhou) delivers turnkey pharmaceutical packaging lines compliant with WHO GMP Technical Report Series No. 961, US cGMP 21 CFR Parts 210/211, and CE Machinery Directive 2006/42/EC. Standard turnkey line delivery: 16–26 weeks (FOB Wenzhou, China).
| Manufacturer | HIJ Machinery (Wenzhou), China |
| Scope | URS → Design → FAT → Installation → IQ/OQ/PQ |
| Line types | Blister line, capsule line, tablet line, complete pharma packaging line |
| Compliance | WHO GMP TRS 961 / cGMP 21 CFR / CE / EU GMP |
| Validation | DQ / IQ / OQ / PQ documentation included |
| Delivery | 16–26 weeks (FOB Wenzhou) |
| Markets | 30+ countries across Asia, Africa, Middle East, Americas |
| Contact | sales@hijpackingmachine.com |
How It Works
HIJ Turnkey Process: URS to PQ Sign-Off
Eight structured phases. One responsible partner. Complete documentation at every stage.
1 URS Review & Consultation
HIJ engineers review your User Requirement Specification. If no URS exists, HIJ helps draft one based on your production parameters, regulatory market, and dosage form requirements.
2 Line Design & Equipment Selection
Engineering team designs the complete line layout — blister machine, capsule filler, cartoner, case packer — matched to your output speed, GMP grade, and facility constraints.
3 Design Qualification (DQ)
Formal DQ documentation prepared confirming that proposed equipment design meets all URS requirements and applicable GMP standards before manufacturing begins.
4 Manufacturing & FAT
Equipment manufactured at HIJ's Wenzhou facility. Factory Acceptance Test (FAT) conducted with customer representative present. FAT report issued before shipment.
5 Delivery & Site Preparation
Equipment shipped FOB Wenzhou. HIJ provides pre-installation checklist covering utilities, cleanroom requirements, and foundation specifications for smooth site readiness.
6 Installation Qualification (IQ)
HIJ engineers install equipment at your facility and execute IQ protocol — confirming correct installation against design specifications, calibration records, and P&ID documentation.
7 Operational Qualification (OQ)
OQ executed by HIJ engineers confirming equipment operates within specified limits across all critical parameters — speed, temperature, pressure, sealing integrity — at low, mid, and high setpoints.
8 PQ Support & Training
HIJ provides PQ protocol templates and operator training. Performance Qualification executed by customer QA team with HIJ remote or on-site support through to final GMP sign-off.
Equipment Range
Complete Pharmaceutical Packaging Equipment Line
HIJ designs and manufactures every machine in the pharmaceutical packaging line — no third-party equipment gaps, no integration risks.
Primary Packaging
Blister Packaging Machines
PVC/PVDC and Alu-Alu cold-form blister machines for tablets, capsules, softgels. 100–600 blisters/min. WHO GMP & cGMP certified.
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Filling
Capsule Filling Machines
Automatic and semi-automatic capsule filling machines for powder, pellets, and liquid. Size 000–5. cGMP compliant.
View machines
Secondary Packaging
Cartoning Machines
Automatic horizontal and vertical cartoning machines for blister packs, bottles, and tubes. Batch code printing included.
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End-of-Line
Case Packing Machines
Automatic case erecting, loading, and sealing machines. Integrated with cartoning line for continuous pharma packaging operation.
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Sterile / Injectable
Pre-filled Syringe Machines
Vacuum filling and capping machines for pre-filled plastic syringes. GMP compliant, suitable for injectable pharmaceutical lines.
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Turnkey Integration
Complete Integrated Lines
Full blister-to-carton-to-case integrated pharmaceutical packaging lines. Single PLC control, synchronized speeds, one validation package.
View solutionsStandard Turnkey Line Configurations
Capsule Line
Capsule Filler
→
Blister Machine
→
Cartoner
→
Case Packer
Tablet Line
Tablet Press
→
Blister Machine
→
Cartoner
→
Case Packer
Alu-Alu Line
Cold-Form Blister
→
Vision Inspection
→
Cartoner
→
Case Packer
Injectable Line
Syringe Filler
→
Blister Packer
→
Cartoner
→
Case Packer
Compliance & Validation
Full GMP Compliance for Every Turnkey Line
Every HIJ turnkey project is engineered and documented to meet the regulatory requirements of your target market — from first design review to final PQ signature.
WHO GMP WHO Technical Report Series No. 961, Annex 6
Equipment qualification requirements for pharmaceutical packaging machinery. HIJ provides pre-written IQ/OQ/PQ protocol templates aligned to WHO TRS 961 Annex 6 requirements.
cGMP 21 CFR Parts 210 & 211
US FDA current Good Manufacturing Practice. All HIJ equipment meets 21 CFR 211.68 requirements for automatic and mechanical equipment used in drug manufacturing and packaging.
21 CFR Pt 11 Electronic Records & Signatures
HIJ high-speed lines include 21 CFR Part 11 compliant data acquisition with audit trail, user access control, and electronic signature capability for FDA-regulated markets.
EU GMP EudraLex Volume 4, Annex 15
Qualification and validation requirements under EU Good Manufacturing Practice. HIJ provides Annex 15-aligned DQ documentation for European market submissions upon request.
CE Machinery Directive 2006/42/EC
All HIJ pharmaceutical packaging machines carry CE marking confirming compliance with EU machinery safety and electromagnetic compatibility requirements.
Validation Documentation Package
Included with every HIJ turnkey pharmaceutical line delivery.
Design Qualification
Formal documentation confirming equipment design meets URS and applicable GMP standards prior to manufacturing
Installation Qualification
Protocol + executed report confirming correct installation per design specifications, with calibration records
Operational Qualification
Protocol + executed report confirming equipment operates within specified parameters at all critical setpoints
Performance Qualification
Protocol template + HIJ on-site support for customer QA team execution under real production conditions
Factory Acceptance Test
Formal FAT executed at HIJ Wenzhou facility before shipment. Report issued and signed by both parties
Site Acceptance Test
On-site SAT execution support by HIJ engineers at your facility after installation and commissioning
Global Reach
Turnkey Pharmaceutical Lines in 30+ Countries
HIJ engineers have installed and commissioned pharmaceutical packaging lines on six continents. Compliance documentation tailored to each regulatory market.
🇮🇳
India — Largest Single Market
CDSCO Schedule M · WHO GMP for export
India is HIJ's largest single market for turnkey pharmaceutical packaging lines. Indian manufacturers face dual compliance: domestic CDSCO Schedule M (Revised) and WHO GMP for export to regulated markets. HIJ delivers documentation packages for both simultaneously.
🌏
Southeast Asia
Vietnam · Indonesia · Philippines · Bangladesh
Pharmaceutical manufacturers across Southeast Asia increasingly require WHO GMP certified turnkey lines to access export markets. HIJ provides complete WHO GMP documentation packages structured for regional regulatory authority submissions.
🌍
Africa & Middle East
Nigeria · Kenya · Egypt · UAE · Saudi Arabia
WHO GMP certification is mandatory for pharmaceutical manufacturers supplying to public health procurement channels including UNICEF and Global Fund. HIJ turnkey lines include WHO GMP documentation packages specifically structured for African and Middle Eastern regulatory submissions.
🌎
Americas & Europe
USA · Brazil · Colombia · EU markets
For pharmaceutical manufacturers supplying to US or EU markets, HIJ provides cGMP 21 CFR and EU GMP Annex 15 compliant configurations with complete validation documentation packages suitable for FDA and EMA regulated submissions.
Why HIJ
Engineered by People Who Have Walked Your Factory Floor
Forester Xiang
Founder & CEO, HIJ Machinery (Wenzhou)
20+
Years
100+
Factories
30+
Countries
"
The most expensive mistake I see pharmaceutical manufacturers make with turnkey projects is choosing a supplier who can build the machines but cannot execute the validation. Your regulatory agency doesn't care about the machine — they care about the documentation. At HIJ, we treat the validation package as the deliverable. The machine is how we get there.
— Forester Xiang, Founder, HIJ MachinerySelected Turnkey Projects
Complete capsule blister line — India, 2024
200M capsules/year · WHO GMP certified · DQ/IQ/OQ/PQ completed
Tablet blister-to-carton turnkey — Southeast Asia, 2024
cGMP compliant · 21 CFR Part 11 · FAT & IQ/OQ executed
WHO GMP packaging line — Nigeria, 2023
WHO GMP for UNICEF supply · Complete validation documentation
Alu-Alu cold-form turnkey line — Middle East, 2023
Moisture-sensitive API · Cold-form blister + cartoner + case packer
Syringe blister + cartoning line — Vietnam, 2024
Injectable product packaging · GMP compliant · On-site commissioning
FAQ
Frequently Asked Questions: Turnkey Pharmaceutical Packaging
What is included in a HIJ turnkey pharmaceutical packaging solution?
A HIJ turnkey solution covers the complete project from URS review through final PQ sign-off. This includes: equipment selection and line design, Design Qualification (DQ) documentation, manufacturing, Factory Acceptance Testing (FAT), delivery, on-site installation, Installation Qualification (IQ) execution, Operational Qualification (OQ) execution, PQ protocol templates, operator training, and post-commissioning support. Single point of responsibility throughout.
How long does a turnkey pharmaceutical packaging line take to deliver?
Standard turnkey line delivery is 16–26 weeks from order confirmation (FOB Wenzhou, China). This includes manufacturing, FAT, and pre-shipment documentation preparation. Complex multi-machine integrated lines with vision inspection and 21 CFR Part 11 systems are typically 22–26 weeks. On-site installation and IQ/OQ execution adds 2–4 weeks at your facility depending on line complexity.
Does HIJ provide DQ/IQ/OQ/PQ documentation for turnkey lines?
Yes. Every HIJ turnkey pharmaceutical packaging line includes a complete validation documentation package: DQ report, IQ protocol and executed report, OQ protocol and executed report, PQ protocol template, FAT report, SAT support, and calibration certificates for all critical instruments. IQ and OQ are executed on-site by HIJ engineers at your facility. PQ is executed by your QA team with HIJ support.
Which GMP standards do HIJ turnkey lines comply with?
HIJ turnkey pharmaceutical packaging lines are designed to comply with: WHO GMP Technical Report Series No. 961 Annex 6, US cGMP 21 CFR Parts 210 and 211, 21 CFR Part 11 (electronic records, available on select models), EU GMP EudraLex Volume 4 Annex 15, and CE Machinery Directive 2006/42/EC. Compliance documentation is tailored to your target regulatory market during the DQ phase.
Can HIJ help if we don't have a URS yet?
Yes. If your team does not have a completed User Requirement Specification, HIJ's engineering team will assist in developing a URS based on your production parameters, dosage form, regulatory market, facility layout, and compliance requirements. This is included as part of the turnkey project scope at no additional charge for standard pharmaceutical packaging line projects.
Does HIJ send engineers for on-site installation globally?
Yes. HIJ dispatches engineers for on-site installation, commissioning, IQ/OQ execution, and operator training at customer facilities worldwide. HIJ engineers have conducted on-site commissioning in India, Bangladesh, Vietnam, Indonesia, Philippines, Nigeria, Kenya, Egypt, UAE, Saudi Arabia, Brazil, Colombia, and Europe. Travel and accommodation costs are discussed during project quotation.
What is the price range for a turnkey pharmaceutical packaging line?
Turnkey pharmaceutical packaging line pricing depends on line configuration, output speed, compliance level, and automation degree. A standard capsule blister + cartoning turnkey line for WHO GMP markets starts from USD 180,000–280,000. Complete blister-to-carton-to-case integrated lines with cGMP documentation range from USD 350,000–600,000+. Contact sales@hijpackingmachine.com with your production requirements for a detailed project quotation within 24 hours.
Is HIJ a manufacturer or a trading company?
HIJ Machinery is a direct manufacturer based in Wenzhou, China. All equipment in HIJ turnkey lines — blister machines, capsule fillers, cartoners, case packers — is designed and manufactured in-house. HIJ does not resell third-party equipment for core line components. This ensures complete documentation control, consistent engineering standards across all machines, and direct engineering support throughout the project lifecycle.