Quality Control (Q.C) Laboratories

In the pharmaceutical industry, quantity and quality are among the most critical principles. Thus, Ensuring the efficacy and quality of pharmaceutical products throughout their shelf life is the foremost and most critical responsibility of manufacturers. Achieving this goal requires stringent and continuous quality control procedures. This explains why adhering to regulations, policies, and quality controls is mandatory and of critical importance.

The Quality Control Department of Noushdaroo Tosan Salamat Pharmaceutical Company, operating under the commercial brand ‘Healthy’, is established over a 300 sq./m facility with multiple GLP-certified units. Backed by experienced management, skilled personnel, and cutting-edge equipment in compliance with the latest international quality control standards, the department is fully committed to evaluating the quality of manufactured products. This department is tasked with the following responsibilities:

1-      Performing inspections and quality assessments for raw materials and packaging materials to ensure their compliance before their clearance

2-      Product Inspection, quality control, and validation

3-      Monitoring production conditions in compliance with GMP standards.

4-      Quality control of the laboratory complex in full compliance with the latest global standards

5-       Conducting validation tests for production lines as part of the Validation Master Plan.

6-       Conducting tests on new products during the product realization process.

7-      Conducting research on Method Analysis.

8-      Conducting periodic testing on a minimum of three batches of each product annually, continuing up to one year beyond the product's expiration date.

The Quality Control Laboratories of Noushdaroo Tosan Salamat Pharmaceutical Company consist of the following departments:

• In-Process Quality Control (IPQC)
• Chemical Laboratory (including Physicochemical and Instrumental Chemistry divisions)
• Microbiology Laboratory
• Documentation Department

This unit is responsible for conducting all physicochemical and microbiological testing of raw materials, packaging components, and final products.

The In-Process Quality Control (IPQC) Lab oversees all production and packaging stages to ensure compliance with GMP regulations at every production phase, from re-weighing to the final product packaging.

The Documentation department of the Quality Control Laboratory prepares and updates Standard Operating Procedures (S.O.Ps), instructions, and analysis sheets (for raw materials and products), as well as S.O.Ps for the operation and cleaning procedures of each laboratory device. These S.O.Ps are regularly updated based on the latest editions of international pharmaceutical references.

In the Chemical Laboratory, a wide range of analyses is conducted. All analyses are conducted according to credible S.O.Ps derived from the latest pharmaceutical references, including the European Pharmacopoeia (EP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), and the Iranian Herbal Pharmacopoeia (IHP), using cutting-edge instruments. These analyses include:

• Chemical testing of raw materials
• thorough testing of final products
• Accelerated and long-term stability tests to ensure products complies with the specified characteristics until its designated expiration date in order to guarantee product quality.
• Chemical control of daily-produced RO water to determine the quantity of prohibited based on approved references,
• conductivity and pH Testing
• Contribution to the execution of internship programs for students referred by higher education institutions, as well as facilitating employee participation in internship, skill-building, and training programs to enhance their knowledge and professional capabilities, and applying the outcomes of these programs to their job responsibilities

Microbiology Laboratory: Since the level of microbial contaminants in chemical, natural, and traditional medicines is one of the most important criteria for assessing medication safety, the personnel in this department follow the latest standards to examine and identify these contaminants with utmost precision. It is important to note that due to the sensitivity of the work in this department and the need to prevent secondary contamination, maintaining sterile conditions throughout various stages of testing is mandatory and adherence to safety protocols and personal hygiene by the staff is of paramount importance.

This laboratory consists of specialized units equipped with state-of-the-art instruments, such as laminar flow hoods, UV lamps, microscopes, and …

In the pharmaceutical microbiology section of company’s QC Lab, microbiological control tests for non-sterile, supplement, natural, and traditional medicines are conducted in compliance with international standards. Additionally, the microbiology laboratory carries out various monitoring and validations, including the validation of water used in the production line, finger tests, and microbial load analysis of raw materials, packaging materials and final products.

It is worth noting that in this laboratory, the accuracy and performance quality of instruments are regularly inspected by the department's experts to minimize error rates.

With its well- designed facilities, cutting-edge instruments, and a team of highly skilled professionals, the Quality Control department of Noushdaroo Tosan Salamat Pharmaceutical Company has firmly established the company as a dynamic unit in the pharmaceutical industry and the medical community. Persistent and effective monitoring and control are the motto of the Quality Control department, and a steadfast commitment to this motto has led to the excellence of the products of Noushdaroo Tosan Salamat Pharmaceutical Company.