Food & Drug Consultation, Inspection, Training
Food & Drug Consultation, Inspection, Training
Let's start with a common language.
A key strength of our company is our ability to respond rapidly and effectively to requests from pharmaceutical industry manufacturers.
The client's project parallels the company's own initiatives, and we are committed to maximizing its optimization.
Years of experience, along with extensive visits and inspections of pharmaceutical industries both in Iran and internationally, provide significant support for our activities.
A Quality Management System represents the foundational framework through which an organization ensures consistent delivery of high-quality products and services while maintaining regulatory compliance. The design and implementation of a QMS involves a comprehensive approach that integrates strategic planning, resource allocation, and continuous process improvement across all organizational functions.
Pharmaceutical facility buildings represent specialized infrastructures designed to meet stringent regulatory requirements and operational standards essential for safe and compliant drug manufacturing. The design and classification of pharmaceutical buildings encompasses comprehensive planning that addresses both functional requirements and regulatory compliance, ensuring the facility can maintain appropriate environmental conditions for product quality and safety throughout production processes.
Calibration, qualification, and validation represent three critical and interconnected processes that form the foundation of pharmaceutical operational excellence and regulatory compliance. These systematic approaches ensure that equipment, systems, and processes function consistently within defined parameters and produce results that meet established quality standards. Together, they provide documented evidence that facilities, equipment, and processes are suitable for their intended purposes and capable of reliably producing compliant pharmaceutical products.
Personnel organization and strategic allocation represent critical components of pharmaceutical operational effectiveness and regulatory compliance. The organizational structure of a pharmaceutical facility must be thoughtfully designed to establish clear reporting relationships, define responsibility domains, ensure adequate competency distribution, and facilitate effective communication across all functional areas. Proper personnel allocation ensures that all critical functions receive appropriate attention, qualified personnel are positioned where needed most, and the organization maintains the capacity to respond to operational challenges while maintaining consistent product quality.
The documentation system represents the critical backbone of pharmaceutical operations, quality assurance, and regulatory compliance. A comprehensive documentation system creates an organized, auditable record of all manufacturing activities, decisions, and quality control measures, providing the evidence base necessary to demonstrate product safety, efficacy, and compliance with regulatory standards. Effective pharmaceutical documentation captures the complete history of product development, manufacturing processes, quality assessments, and distribution, ensuring traceability and accountability throughout the product lifecycle.
Any activity covered by the GMP Guide that is outsourced should be appropriately defined, agreed and controlled in order to avoid misunderstandings which could result in a product or operation of unsatisfactory quality. There must be a written contract between the Contract Giver and the Contract Acceptor which clearly
establishes the roles and responsibilities of each party.
Pharmaceutical production represents the core operational function where raw materials are systematically transformed into finished pharmaceutical products through carefully controlled manufacturing processes. Effective pharmaceutical production integrates sophisticated equipment, highly trained personnel, stringent environmental controls, and comprehensive monitoring systems to ensure that every manufactured batch consistently meets established specifications for safety, efficacy, potency, and quality. Production operations must simultaneously achieve operational efficiency while maintaining absolute compliance with Good Manufacturing Practices (GMP) and all applicable regulatory requirements.
Quality Control (QC) represents the laboratory and analytical function responsible for evaluating pharmaceutical products and materials to ensure compliance with established specifications and regulatory requirements before product release. Quality Control serves as the critical checkpoint preventing non-compliant products from reaching patients, conducting comprehensive testing on raw materials, in-process materials, finished products, and environmental samples. Effective Quality Control combines sophisticated analytical instrumentation, highly trained technical personnel, validated analytical methods, and robust documentation systems to provide objective evidence supporting product safety, identity, strength, purity, and quality.
Quality Assurance (QA) represents the comprehensive systematic function responsible for ensuring pharmaceutical products consistently meet established quality standards through preventive oversight, process monitoring, and regulatory compliance verification. Unlike Quality Control, which focuses on product testing and release decisions, Quality Assurance encompasses broader organizational responsibilities including quality system design, process validation, regulatory compliance auditing, deviation investigation, change management, and continuous improvement initiatives. Quality Assurance serves as the guardian of organizational quality culture, establishing systems and procedures that prevent quality problems rather than merely detecting them after occurrence.
AmirAbad, Tehran, Iran
Pardis Technology Park, Pardis, Tehran
+98 922 480 1299
contact@fdcitofficial.com
Get in touch with our expert team via WhatsApp at +98 922 480 1299 for consultations on pharmaceutical quality management. We specialize in Food & Drug Consultation, Inspection, and Training, ensuring compliance through effective Quality Management Systems. With extensive experience in the pharmaceutical field, we are dedicated to delivering high-quality products and services. From documentation processes to personnel allocation and production oversight, we prioritize accountability and excellence for our clients. Initiate your consultation today and enjoy prompt, responsive support tailored to your pharmaceutical needs.