We offer comprehensive solutions for Quality Assurance, Good Manufacturing Practices (GMP), and Good Distribution Practices (GDP). Our services ensure compliance with international standards, enhance operational efficiency, and maintain the integrity of products throughout the manufacturing and distribution process, supporting excellence in healthcare and wellness industries.

1: Project Management: Recruitment of qualified staff for product development and supervising all development phases, from material procurement to stability testing.
 

2: Quality Control and Good Laboratory Practices:Establishing specifications for raw materials and finished products. Implementing systems for data retention, discrepancy investigations, and OOS procedures.

3: Laboratory and Equipment Setup: Providing lab layouts, required instruments, and equipment lists. Assisting in lab construction and furnishing for R&D activities.

4: Heat Mapping Study

5: SOP Services

6: Training

7: Pre-inspection and CAPA Inspection Report

Phases of the Project management include the following:

  • Section One - Scope of work

I. Planning Phase:

1. Collaborating with the client to choose its product portfolio, either through a specialized company or internally hired sales/marketing teams.

2. Deciding on production lines and capacity based on the agreed product portfolio and forecast.

3. Bringing in international and regional companies to handle contract packaging/manufacturing at the client’s site and securing business agreements.

4. Supervising the client’s Regulatory Affairs (RA) team to register contract providers and products for secondary packaging activities.

II. Pre-Facility Establishing Phase:

1. Providing layouts for manufacturing and packaging facilities, laboratories, and warehouses, ensuring compliance with cGMP, GDP, and GLP standards.

2. Constructing the facility with several rooms for production, raw materials, finished product storage, quality control laboratories, workshops, utilities, and more.

3. Selecting pharmaceutical engineering companies for conceptual and detailed engineering designs and EMP work.

4. Providing User Requirements specifications for clean rooms and HVAC systems, ensuring operations are conducted under clean, sanitary conditions.

5. Choosing local engineering companies for civil engineering designs and EMP.

6. Specifying requirements for utilities such as HVAC, pure steam, clean steam, and stainless steel piping networks.

7. Qualifying and selecting suppliers for utilities, machines, and laboratory instruments.

8. Providing User Requirements specifications for machinery and laboratory instruments.

III. Facility Establishing Phase:

1. Overseeing facility construction, ensuring it follows the approved design, including civil work, electricity, waste network, and overall infrastructure.

2. Monitoring the construction schedule and reporting delays and challenges to the client’s management.

IV. Post-Facility Establishing Phase (Before Operation):

1. Supervising clean room validation and qualification.

2. Overseeing mechanical erection, pre-commissioning, and commissioning of all process equipment.

3. Conducting qualification (IQ, OQ, PQ) for manufacturing site machinery and instruments with their suppliers.

4. Managing total validation and qualification studies, including:

    • Utilities qualification
    • Cleaning validation
    • Process validation

5. Preparing the organizational structure for the facility.

6. Creating job descriptions for required staff.

7. Selecting qualified staff for recruitment.

8. Preparing the Validation Master Plan for the client.

V. Post-Facility Establishing Phase (During Operation):

1. Training staff and handing over the facility after performance tests and regulatory agency approvals.

2. Ensuring proper implementation of materials handling and warehousing systems.

3. Overseeing the implementation of manufacturing systems to ensure processes are well-defined and approved.

4. Ensuring the proper implementation of packaging and labeling systems to ensure they follow comprehensive written procedures.

5. Supervising the implementation of laboratory control systems related to sampling, testing, documentation, and release procedures.

6. Monitoring the implementation of the Quality System for GMP-compliant manufacturing processes.

7. Assisting the client in obtaining EU/FDA/MOH and GCC GMP accreditation for the manufacturing site.

  • Section Two - Approach:

To support the business objectives outlined above, the project management team must achieve the following goals:

1. Team Formation: Form a collaborative team consisting of both Care Icon Consultancy staff and the newly recruited client personnel. Ensure that all team members understand the key benefits and features of the new system. Care Icon Consultancy will assist in recruiting the necessary staff to execute the system effectively.

2. Scope Definition: Ensure that the detailed scope of the core system, as outlined in Care Icon Consultancy’s solutions, is clearly defined and understood by all team members. This will be reflected in the task plan provided after signing the agreement.

3. System Implementation: Ensure the planned implementation of the system is carried out efficiently and as per the schedule.

4. Team Collaboration: Foster team cooperation and facilitate the sharing of resources to ensure smooth operations throughout the project.

5. Training and Capacity Building: Conduct comprehensive training sessions for staff at all levels to build capacity and ensure effective system operation.

  • Section Three: Facilities design and finishes:

General:

  • The premises will be carefully located, designed, constructed, adapted, and maintained to suit the operations to be carried out.
  • The layout will be designed to ensure a logical flow of materials.
  • The premises’ design will minimize the risk of errors and facilitate effective cleaning and maintenance to prevent cross-contamination, dust build-up, and other factors that could negatively impact product quality.

Ancillary Areas:

  • Facilities for changing and storing clothes, as well as washroom purposes, will be in full compliance with cGMP standards.

Storage Areas:

  • Storage areas will have sufficient capacity to allow the orderly storage of various categories of materials and products, ensuring proper separation and segregation.
  • Storage areas will fully comply with GDP (Good Distribution Practices) guidelines.

Weighing Areas:

  • Dedicated weighing areas will be designed with provisions for dust control. These areas will be strategically located within storage or production zones.

Production Areas:

  • Production areas will be arranged to ensure a logical sequence of operations, with proper cleanliness standards maintained throughout the process.
  • Floor-wall joints, building columns, equipment pads, and other obstructions will be fully sealed to prevent contamination.
  • Pipework, light fittings, ventilation points, and other services will be designed and positioned to eliminate hard-to-clean recesses. Maintenance access will be provided outside of production areas.
  • Drains will be appropriately sized and designed to prevent backflow, with sloped floors directing liquids toward the drains to prevent accumulation.
  • Access to critical parts of equipment for cleaning and maintenance will be ensured to streamline operational efficiency.
  • Section Four: Deliverables

1. Pre-Facility Establishing Phase:

    • Preliminary layout of the facility, including:
      • Solid dosage forms manufacturing and packing
      • Semi-solid dosage forms manufacturing and packing
      • Labeling, packaging, and cartoning
      • Utilities
    • Approval of conceptual and detailed engineering designs
    • Development of the site master file
    • Specifications for equipment and materials
    • Clean room specifications
    • Pharmaceutical water & pure steam plant (PW, WFI, PS generators, loops, tanks, pumps, pipes) specifications
    • User requirements specifications for facility utilities, including:
      • Clean room HVAC systems
      • Pure steam, clean steam, purified water systems
      • High-grade stainless steel piping networks with all accessories
    • User requirements specifications for facility machines and laboratory instruments
    • Create layouts for laboratories and storage areas

2. Post-Facility Establishing Phase, Before Operation:

    • Clean room and machine installation, commissioning certificates
    • Machine SAT (Site Acceptance Test) test acceptance certificate
    • Purified water plant and distribution loop layout

Quality System:

Standard Operating Procedures (SOPs) to include:

  • Product review
  • Complaint handling
  • Deviations and failure investigations related to manufacturing and testing
  • Change control
  • Reprocess/Rework
  • Returns
  • Rejects
  • Out of Specification (OOS) handling
  • Materials and product release
  • Validation (e.g., manufacturing process, laboratory methods)
  • Training/qualification of personnel

Facilities:

  • Cleaning and maintenance
  • General air handling systems monitoring and control
  • Control system for implementing changes in building operations
  • Sanitation, use of rodenticides, insecticides, cleaning, and sanitizing agents

Equipment:

  • Equipment installation and operational qualification reports
  • Cleaning validation protocols
  • Controls to prevent contamination from pesticides, toxic materials, or other chemicals
  • Protocols for equipment calibration and maintenance
  • Equipment identification practices (where appropriate)
  • Investigation protocols for unexpected discrepancies

Materials and Warehouses:

  • Identification and inventory procedures for components, containers, and closures
  • Storage conditions monitoring and control procedures
  • Storage under quarantine procedures
  • Representative sample collection and testing procedures
  • Supplier test result validation for components, containers, and closures
  • Rejection procedures for materials
  • Re-testing and re-examination procedures for components, containers, and closures
  • First-in, first-out (FIFO) storage procedures for components, containers, and closures
  • Finished product distribution records by lot
  • Investigation procedures for unexpected discrepancies

Production:

Procedures to include:

  • Change control system for implementing process changes
  • Identification of manufacturing phases and status
  • Calculation and documentation of actual and theoretical yields
  • Complete batch production documentation
  • Justification and consistency of in-process specifications and final drug product specifications
  • Equipment cleaning and use logs
  • Process validation
  • Investigation protocols for unexpected discrepancies
  • Line clearance, inspection, and documentation

Packaging and Labeling:

Procedures to include:

  • Change control system for packaging and labeling operations
  • Label storage and control procedures
  • Packaging records including specimens of all packaging materials used
  • Control of packaging and labeling issuance
  • Examination of packaged and labeled finished products
  • Physical separation between different labeling and packaging lines
  • Line clearance, inspection, and documentation

Quality Control Labs:

Procedures to include:

  • Calibration and maintenance programs for analytical instruments
  • Reference/working standards control
  • Sampling procedures
  • Validation/verification of analytical methods
  • Control system for laboratory operation changes
  • Investigation protocols for unexpected discrepancies
  • Complete analytical records from all tests
  • Quality and retention of raw data (e.g., chromatograms and spectra)
  • Out of Specification (OOS) investigation and resolution
  • Reserve sample collection and examination documentation
  • Section Five : Project Duration:

1. Planning Phase: Estimated duration – 3 months

2. Pre-Establishment Phase: Estimated duration – 6 months

3. Establishment Phase: Estimated duration – 9 months

4. Post-Establishment (Pre-Operation) Phase: Estimated duration – 6 months

Our Partners

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Pharma United

LaVida Health