INJECTABLES TURNKEY DESIGN

Hospaccx has large network of expert and global and local suppliers. We take a complete responsibility to undertake complex and unique projects and deliver quality and timely solutions which meet industry safety standards. We as a team offer project execution in accordance with the specific requirement of Injectables by our clients. We provide turnkey solutions also from green field to commissioning of facility as per international regulatory norms like USFDA, TGA, UKMHRA, WHO GMP, ISO 9000, MCA, cGMP, MHRA, EU and PICs, etc. We work in different combination of responsibilities depending on customer requirements. It can be an EPC (Engineering, Procurement & Construction) contract including complete construction of infrastructure and supply and commissioning of production machinery and systems or it can be a Procurement Management contract.

The services included in this:

1. Advisory and Consulting

1. Feasibility Analysis of Injectables, comprising of
   1. Market Feasibility Study
   2. Technical Feasibility Study
   3. Financial Feasibility Study
2. Technology Sourcing and Transfer
3. Technical Assessment and Due Diligence
4. cGMP audit of existing and / or new facilities to confirm their compliance with the EU GMP, UK MHARA, US FDA, PIC/s, MCC. ANVISA, WHO etc. Recommendations of measures to upgrade existing facilities to such International standards.

2. Site Master Planning. Sequential approach to develop the Site Master Plan:

1. Project Objective covering the different Injectables planned to be manufactured with the projected capacities along with the desired approvals/compliances (considering the target market) and the timelines.
2. Strategic Planning (Phase-out Plan)
3. Number of Building and Blocks envisage
4. Site Analysis
5. Regulatory Compliance
6. Location and Orientation of the buildings and blocks
7. Facilities and Amenities Planning
8. Building Floor Levels
9. Land Scaping

3. Concept Engineering
4. Design and Engineering
5. Procurement Assistance
6. Project and Construction Management
7. Documentation

1. Qualification and Validation
   1. Project planning and Management

• Validation documents, Validation Master Plan (VMP), Equipment Validation Plan (EVP), Risk Assessment (RA), and Impact Assessment (IA).
• Master Validation / Qualification Schedule.

1. 2. Qualification Protocols – Equipment and Computer System Validation

• Design Qualification
  • • Review of User Requirement Specification (URS) considering the GMP Risk Analysis
    • Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
    • Prepare Design Qualification protocol and establish qualification for each equipment
• Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
• Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
• Preparation/ Review of Area/ Facility Qualification Protocols
• Preparation of Qualification Protocols (SRS, RA, PVP, ERES, HLRA, IQ, OQ, PQ) for PLC, HMI, SCADA, Camera System in Compliances with GAMP 5 and 21 CFR Part 11
• Preparation of Product Microbial Limit Test (MLT), BET, Bio-Burden, & Sterility Method Validation Protocols
• Preparation of Analytical Method Validation/ Verification Protocols
• Preparation of Vendor Qualification Protocols for Raw & Packing Materials
• Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements

1. 3. Execution of Qualification Process and final documentation at client’s site.
   4. Inspection / FAT at Vendor’s site

2. Standard Operating Procedures

1. 1. Process

• Preparation of Procedures for Operation, Cleaning and Preventive Maintenance
• Preparation of Procedures for Environment Monitoring
• Preparation of Procedures for Calibration of Master Instruments and Process Instruments
• Preparation of Calibration Schedules – Equipment wise
• Preparation of procedures for Operation, Cleaning, Sterilization, Disinfection, Sanitization & Monitoring
• Preparation of procedures for Gowning & De-Gowning
• Preparation of procedures for Personnel Hygiene Monitoring and control
• Preparation of procedures for Area Monitoring and control

2. 2. Quality Control

• Review of Instrument Qualification Protocols & Monitoring of Commissioning Activities
• Preparation of Instrument Calibration Schedule and Monitoring of Calibration Activities
• Preparation of Procedures for Testing Activities of Water, Nitrogen, Raw Materials, In Process Material, Packing Material and Finished Products
• Preparation of Procedures for Testing Activities of MLT/ Bio burden in Purified Water, WFI, Pure steam, Raw Materials & Product
• Preparation of Procedures for Testing Activities of BET in Purified Water, WFI, Pure Steam, Raw Materials and Product
• Preparation of Procedures for Testing Activities of Product Sterility Testing
• Preparation of Procedures of Media Preparation, Sterilization, Plate Preparation, Exposure Activities
• Preparation of Procedures of Culture Suspension Activities & Organism Identification
• Preparation of Standard Test Procedures, General Procedures, Stability Specifications and Other Miscellaneous Test Procedures
• Preparation of Procedures of Biological Indicator Qualification & Handling
• Preparation of Procedures of Incubation & Inspection Activities
• Training to Concerned Persons, Monitoring of Execution and Review of Reports
• Preparation and Develop the Disinfectants Validation Protocols, Monitoring the Execution and Review the Reports

2. 3. Warehouse

• Preparation of Procedures for Goods Receiving, Storage, Segregation, Sampling, Dispensing and Issuance
• Preparation of Procedures for Monitoring /recording of Storage condition
• Preparation of Procedures for storage of Finished Goods

3. Quality Management System – QMS

• Master Project Quality Plan
• Project Quality Risk Assessment documents
• Equipment Quality Risk Assessment documents
• Process Quality Risk Assessment documents
• Quality Impact Assessment documents for assessing equipment as Direct, Indirect and No Impact on Quality
• Quality Manual & Training Manuals
• Site Master File
• Change Control System
• Deviation Control System
• Incident Control System
• Out of Specification System
• Market Complaints and Product Recall Handling System
• Internal Audit / Self Inspection
• Manufacturing Activities Monitoring System
• Analytical Assurance & Monitoring System
• Microbiology Assurance monitoring system
• Engineering Assurance Monitoring System
• Documentation System
• CAPA System
• Annual Product Review System
• Management Review System
• GLP System
• Calibration Policy and Master Calibration Schedule
• Development of Training Schedule for all Plant Personnel

8. Regulatory Compliance Support

1. Strategic Services

• Strategic assistance in Pharma Regulatory filing
• Support in Outsourcing Manufacturing or Testing Laboratories for Clients
• Support in Outsourcing BA/BE study centers

2. Advisory Services

• cGMP (current Good Manufacturing Practice) compliance
• Advisory services to queries pertaining to pharma GMP, GLP, QA and regulatory affairs
• Compliance audits as per current and updated statutory pharma regulations
• Critical Review of Dossiers
• GAP Analysis/Due diligence

3. Technical Assistance

• Preparation of Injectable Substance and Injectable product registration dossier
• Dossier Preparation & Submissions in CTD [(Electronic Common Technical Document (drug registration)]/eCTD, ACTD [Asian Common Technical Dossier]
• NeeS [Non-eCTD electronic Submissions (NeeS)] formats to different Health Authorities of Regulated and Semi-Regulated markets like US-FDA, Health Canada, Europe, UK-MHRA, MCC-SA, ANVISA, ASEAN countries and ROW markets including Indian DCGI and CDSCO
• Preparation of DMF [Drug Master Files]/ ASMF [Active Substance Master File] / CEP [Certificate of Suitability] or (CoS) / KDMF/ Technical Packages
• Site Master file as per PIC/s & Local FDA requirement

9. Training and Development

• • Standard Operating Procedures – QA/QC/Manufacturing/Maintenance
  • On the job Training for QA/QC/Shop floor employees
  • Process Validation
  • Installation Qualification
  • Operational Qualification Method Validation
  • Facility Qualification
  • Purified Water validation
  • Current Good Manufacturing Practices
    • Transferring Skill on Validation
    • GLP System and testing
    • Clean Room Operations, Equipment Handling and Documentation Activities
    • Personal Behavior in Clean areas
    • Calibration Procedures and Maintaining Records
    • Conduct Mock Audits
• How to prepare & FACE Regulatory audits
• WHO guideline
• COST Improvement Projects
• Technology Transfer
• Statistical Process Control
• Conducting Training and Workshops on RA/QA-QM/AD/FD/ICH/CTD/eCTD/ACTD/21CFR parts/GMP/GLP/GCP [Good Clinical Practice]-Clinical etc. with Case studies
• Provide different training modules as per the customer specific requirements in RA, QA, cGMP, GLP, GCP, ISO, 21 CFR parts, Audits, Validations, QbD, and many more topics….
• Provide following different types of Training programs
  • • Instructor-led courses
    • In-house company trainings
    • Certificate programs
    • Distance learning courses
    • Online trainings
    • Fast-track programs

We at Hospaccx, thus provide a complete handhold from planning to manufacturing and training of individual involved in Injectables. From advising and consulting to training and development, we aim at providing assistance at every phase of your project for Injectables in Pharmaceuticals.

Related Team Members