Our expert team provides comprehensive services to help you prepare for and successfully pass global, regional and local inspections. Our services include:

• Situation Analysis
• Planning the CAPAs
• Implement Corrective Actions
• Verify Effectiveness
• Mock Inspections Conduction
• Training and Capacity Building
• Inspection Accompaniment

We do systematic evaluations of a facility to assess its compliance with GMP regulations and industry standards. We can offer the following auditing services:

• INTERNAL AUDITS:
  Assisting clients in conducting internal audits to identify areas for improvement and maintain compliance.
• EXTERNAL QUALITY AUDITS:
  Conducting independent audits on behalf of regulatory authorities or clients to verify compliance.
• SUPPLIER AUDITS:
  Evaluating suppliers and contractors to ensure they meet GMP standards and can provide quality products or services.
• REGULATORY AUDITS:
  Preparing clients for regulatory inspections and providing support during the audit process.
• CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) IMPLEMENTATION:
  Helping clients develop and implement CAPA plans to address audit findings and prevent future non-compliances.

Identifying the gaps between a company’s current practices and GMP requirements. We can help companies prioritize areas for improvement and develop a roadmap for compliance. We can offer the following GAP assessment services:

• GMP COMPLIANCE ASSESSMENT:
  Evaluating a company’s entire operation against GMP standards to identify areas of non-compliance.
• SPECIFIC AREA ASSESSMENTS:
  Focusing on particular areas such as manufacturing, quality control, or documentation.
• REGULATORY COMPLIANCE ASSESSMENT:
  Assessing a company’s compliance with global and local regulatory requirements.
• RISK ASSESSMENT:
  Identifying potential risks to GMP compliance and developing mitigation strategies.
• GAP ANALYSIS REPORT:
  Providing a detailed report outlining the gaps identified and recommending corrective actions.

This service involves creating detailed blueprints and plans for pharmaceutical manufacturing facilities or processes that adhere to Good Manufacturing Practices (GMP).
These designs are customized to meet the specific needs and requirements of each client, taking into account factors such as:

• FACILITY LAYOUT:
  The arrangement of equipment, machinery, and storage areas to ensure efficient workflow and prevent cross-contamination.
• PROCESS FLOW:
  The sequence of steps involved in manufacturing products, from raw material handling to final packaging.
• UTILITIES AND INFRASTRUCTURE:
  The design of systems for water, electricity, ventilation, and other essential services.
• REGULATORY COMPLIANCE:
  Ensuring that the facility and processes meet all relevant GMP standards and regulations.
  By optimizing workflow and logistics, these conceptual designs can help clients improve efficiency, reduce costs, and enhance product quality.

This service focuses on providing specialized engineering solutions related to the electrical and mechanical systems of pharmaceutical facilities. These solutions can include:
A. ELECTRICAL SYSTEMS:
Design and installation of power distribution, lighting, control systems, communication & security systems.
B. MECHANICAL SYSTEMS:
Design and installation of HVAC systems, cleanrooms, piping systems, and other mechanical equipment.
C. AUTOMATION AND CONTROL:
Implementation of automation technologies to improve efficiency and reduce human error.
D. ENERGY EFFICIENCY:
Development of strategies to minimize energy consumption and reduce operating costs.

Our team of experienced professionals provides comprehensive third-party quality assurance services to ensure the seamless integration of equipment and systems into your pharmaceutical manufacturing operations.

• URS Development
• Documentation Review
• Design Qualification (DQ) Development
• FAT Witnessing: SAT Planning and Execution
• Regulatory Compliance
• Qualification Witnessing

A robust Quality Management System (QMS) is the cornerstone of any successful manufacturing operation. Our experienced team can help you establish and maintain a QMS that is aligned with regulatory requirements (e.g., GMP, ISO 13485) through its following key elements:

A. Standard Operating Procedures (SOPs): SOP will be developed (with its records templates) for the following:

• Product quality review (PQR)
• Deviations Handling
• Out-of-Specification (OOS) Investigations
• Corrective and Preventive Action (CAPA)
• Change Management
• Quality Risk Management (QRM)
• Vendors Management
• Contract activities
• Complaint Handling
• Product Recall Management
• Self-Inspection
• Training Program
• Sanitation and hygiene
• Validation activities
• Other QA activities
• Other areas activities

B. Quality Manual

C. Site Master File (SMF)

D. Validation Master Plan (VMP)

E. Jobs Description

At GMPintro, we understand the critical role of a well-trained workforce in ensuring manufacturing excellence. Our comprehensive training programs are designed to empower your team with the knowledge and skills needed to meet regulatory and industry standards. They are as follows:

1. Pharmaceutical Quality System
2. Premises
3. Production
4. Water for pharmaceutical use
5. Qualification and Validation
6. Process Validation
7. Cleaning Validation
8. Computerized System Validation
9. Sterile Manufacturing
10. Laboratory Controls
11. Good Documentation Practices
12. Continual Improvement

• Our comprehensive regulatory services support pharmaceutical companies throughout the product lifecycle.
• From pre-clinical development to post-market surveillance, we provide expert guidance on regulatory submissions.
• Our team of experienced professionals ensures that your products meet the highest regulatory standards and achieve timely market access.