Medicinal Products

We provide comprehensive consulting services in the following areas:

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Preparation of Pharmaceutical Quality System (PQS) documentation in compliance with GMP requirements
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Development of User Requirement Specifications (URS) for cleanrooms

Preparation of Pharmaceutical Quality System (PQS) Documentation in Compliance with GMP Requirements

We offer extensive support in creating and implementing a efficient Pharmaceutical Quality System tailored to the specific needs of medicinal product manufacturers. This includes:

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Developing policies, procedures, and working instructions that align with GMP (Good Manufacturing Practice) guidelines.
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Establishing systems for quality risk management to ensure compliance throughout the product lifecycle.
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Supporting the implementation of effective change control, deviation management, and CAPA (Corrective and Preventive Actions) systems.
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Preparing for GMP certification inspections by conducting internal reviews and mock inspections.
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Providing guidance on ensuring data integrity and electronic records compliance.

Our services help meet regulatory requirements and build an effective quality management system for pharmaceutical products.

Development of User Requirement Specifications (URS) for Cleanrooms

Our expertise ensures cleanroom facilities meet regulatory, operational, and product-specific requirements by providing:

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Comprehensive assistance in drafting User Requirement Specifications (URS) based on GMP Annex 1 and ISO 14644 standards.
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Recommendations for cleanroom design, layout, and classification tailored to the needs of the manufacturing processes.
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Guidance on contamination control strategies, including airflow design, environmental monitoring, and equipment placement.
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Collaboration with engineers and architects to ensure facilities are built to regulatory and functional specifications.
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Support in defining technical specifications for cleanroom validation, such as HVAC systems, pressure differentials, and particle count limits.

Our services help manufacturing companies meet the highest regulatory and quality standards.