SERVICES
wide range of services
1. Feasibility Study
The feasibility study focuses on helping answer the essential question of “should we proceed with the proposed project idea?” All activities of the study are directed toward helping answer this question.
The feasibility study outlines and analyses several alternatives or methods of achieving business success. Conducting a feasibility study is a good business practice. Below are reasons to conduct a feasibility study.
- Gives focus to the project and outline alternatives.
- Narrows business alternatives
- Identifies new opportunities through the investigative process.
- Identifies reasons not to proceed.
- Enhances the probability of success by addressing and mitigating factors early on that could affect the project.
- Provides quality information for decision making.
- Provides documentation that the business venture was thoroughly investigated.
- Helps in securing funding from lending institutions and other monetary sources.
- Helps to attract equity investment.
2. Conceptual & Basic Design
The Conceptual & Basic Design focuses on helping answer the essential question of “how to establish good layout design of manufacturer considering future expansion capabilities” This will outlines and analyses several alternatives or methods. Some essential information will be delivered are:
- Description of the facility and future expansion capabilities
- Regulatory compliance standard related
- Current and future production estimates
- How to achieve production needs
- Waste handling and disposal
- Building construction concepts and materials recommended
- Materials and personnel flow
- Utilities requirements
- HVAC Zoning & Zone Classification
- ETP & Safety concept
- Implementation strategy
- Automation and monitoring requirement
3. Detailed Design
The Detailed Design focuses on develop Conceptual & Basic Design into the visible project planning. This will present more detail information needed to implement project. Some information will be produced are:
- Detail Architectural Layout and Structural Design
- Detail HVAC design
- Detail Utilities design
- Detail Mechanical and Electrical design
- Instrumentation design
- Environment Treatment System Design and Fire Fighting System Design
- Building Management and Automation system design
4. Equipment Selection Assistance
Equipment Selection Assistance focuses to get the right machinery, equipment and its system based on client’s user requirements. This will present more detail information needed to select the best equipment. Some activities will be taken are:
- Detail technical specification and data sheet
- Alternatives of equipment from various supplier
- Tender of supply and installation of equipment and/or systems eg. Production Equipment, HVAC system, Purified Water System, Pure Steam Generator System, Electrical System, Waste Water Treatment System
- Technical Clarification and recommendation to the best alternative
- Checking & Approval of vendor drawing
- Checking & Approval of contractor site erection drawing
- Factory Acceptance Test protocols
- Factory inspection of equipment prior to dispatch
5. Project & Construction Management
Project & Construction Management focuses to construct and implement building as planned. Some activities will be taken are:
- Scheduling, Monitoring and Supervise construction and installation activities
- Compile project weekly and monthly progress report, highlight any bottleneck and propose solution to expedite works
- Managing site logistics and contractor activities
- Controlling HSE site implementation
- Monitoring onsite material align with approved material specification
- Carrying out site testing for mechanical installation
- Documentation of all testing report and certificates
- Assure compliance of As-built drawing
6. Qualification & Validation
Qualification and Validation focuses into preparation good quality assurance system of the facility. This will assure the installed equipment and system are meets its pre-determined specification and quality attributes. Some activities will be taken are:
- Site Master File , Validation Master Plan Protocols
- Support to make User Requirement Specification (URS)
- Design Qualification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Testing and Measurement with calibrated devices
APC has many experiences in Qualification & Validation of following areas:
- Production Equipment
- HVAC System
- Purified Water System
- Pure Steam Generator System
- Compressed Air System
7. GMP Auditing
GMP Auditing focuses into preparation of audit related with respective GMP certification. APC has many experts’ staff who could conduct mock-up audit for relevant GMP standards i.e. BPOM Indonesia Certification, EU, PICs Certification, UK MHRA, TGA Australia Certification, US FDA Certification, and WHO PQ Certification. Some activities will be taken are:
- Compliance Audits
- Documentation Audits
- Supplier Audits
- Quality System Audits
- GMP / GLP Audits
8. Seminar, GMP Training
APC has complete modules of training with regards to GXP in Pharmaceutical and Biotechnology Environment. Emphasis is being put on the importance of Good Manufacturing Practice, Good Laboratory Practice and Validation. We have organized at a quarterly interval a general seminar to enhance staff skill in the GXP.