Pharmaceutical, Biotechnology and Medical Device Validation services have been introduced to the ALD scope of activities in 1999 as an answer to the growing need in equipment and process validation in Israel and worldwide. ALDs' reputation has helped to gather a unique multi-cultural validation team consisting of high level experts with expertise and capabilities to provide an innovative approach to validation of the state of art systems required at Pharmaceuticals and Biotechnological facilities.
On an existing project ALD will provide expert consultants on cGMP issues as well as assistance in validation services. On a new pharmaceutical, bio-technological or medical device plant, ALD provides the ability to link the engineering and validation aspects from the very start of a project. ALD validation experts will develop a validation master plan in compliance with validation requirements, and will develop customized standard operating procedures.
Our validation team performs:
• Development of the Validation Master Plan
• cGMP Compliance Guidance
• cGMP / Quality Audits
• Preparation for US FDA and UK MCA approval
• Development of Standard Operating Procedures (SOPs)
A validation master plan organizes the handling of a validation project, lists the systems and equipment requiring validation, defines the parameters to be validated at every stage and aspect of the validation, states responsibilities and defines acceptance criteria. All these facilitate organization and clear definition of all validation aspects.
ALD Validation team works in cooperation with one of the world leaders in validation service - Pellemon, Canada - one of the subsidiaries of SNC-Lavalin.
ALD validation team will provide the GAMP Software development guidance, assistance in building of automation system. We will validate your DCS, SCADA, LIMS, ERP/MRP or custom-built system.
Production Facilities Validation
ALD validation experts perform a full range of the validation activities for production facilities as well as for research and development. We will create and execute the validation protocol including:
• Installation Qualification (IQ) verifying the installation of all system or equipment components in accordance with approved specifications, drawings, and manufacturer's / supplier's recommendations
• Operational Qualification (OQ) verifying control loops, alarm signals, indicator lights, monitoring points and all documentation required for the operation and maintenance of the equipment.
• Performance Qualification (PQ) organizing all documentation needed to prove that the system constantly and repetitively operates in conformity with reference document requirements.
Review for Clean Room Design
ALD validation team has special expertise in design, construction and testing of clean rooms requiring knowledge of diversified requirements for air cleanliness and testing methodology in compliance with the international standards.
• Clean Room Classification and Layout Requirements in Compliance with GMP, FDA and EC
• Critical Systems Design Requirements Including:
o HVAC Systems - Air Quality and Pressure Cascade
o Clean Steam
o Compressed Air and other Gases.
HACCP for the Food Industry
Dairy & Meat Products:
• Mapping of Production Process
• Identification of Critical Control Points
• Establishment of Limits
• Verification and Validation of Limits at All Critical Control Points as Required by the Process
• Maintenance of Validated State
• Assistance in Preparation for HACCP Inspection by Regulatory Bodies such as FDA