GMP audits to ensure your manufacturing processes, equipment, and facilities meet the Industry Regulatory standards.

GMP Audit Covers

Quality Management Systems (QMS)

Ensure compliance with industry-specific quality standards.

Facility and Equipment Audits

Ensure your production environment meets regulatory and safety requirements

Personnel Qualification

Evaluate staff training and qualifications to ensure proper execution of SOPs.

Raw Materials and Components

Audits to confirm the integrity and quality of inputs used in manufacturing.

Production Processes

Comprehensive review of production flows and control systems.

Packaging and Labelling

Verification of labelling accuracy and compliance with packaging regulations.

Laboratory Controls

Evaluate the accuracy and reliability of your lab testing procedures.

Documentation and Record Keeping

Ensure full compliance with documentation requirements to avoid regulatory issues.

Complaint Handling and Product Recalls

Examine your processes for managing customer complaints and recalling faulty products

Validation and Qualification

Review of process validation to ensure consistent product quality.

Regulatory Compliance

Ensuring adherence to local and global regulatory standards.

GMP Audit Approach

Initial Assessment & Gap Analysis:

We start with a thorough pre-assessment of entire supplier processes and systems to identify gaps and areas for improvement, ensuring alignment with GMP guidelines

Customized Compliance Strategy:

Based on the pre-assessment, we draft a tailored audit strategy that aligns with global standards and regulations.

Process Validation & Qualification:

We ensure your production processes consistently meet standards by validating equipment, raw materials, and methods to maintain GMP compliance.

Documentation & Record Keeping:

We ensure your suppliers are following proper documentation practices, ensuring all records are accurate, up-to-date, and traceable.

Facility & Equipment Audits:

Our experts review all facilities and equipment for cleanliness, maintenance, and layout to prevent contamination and ensure quality.

On-going Monitoring & Support:

We provide post-audit support to help your business stay compliant with evolving GMP regulations.