Scythian Healthcare

Quality Control

Quality control (QC) is a crucial aspect of the pharmaceutical industry to ensure that products meet the required standards of quality, safety, and efficacy. The quality control process in a pharmaceutical company involves a series of systematic steps to monitor and evaluate various aspects of production. Here is a general outline of the quality control process in our company:

Sampling and Testing:

Raw Materials: Incoming raw materials, such as active pharmaceutical ingredients (APIs) and excipients, are sampled and tested to ensure they meet specified quality standards.

In-Process Samples: Samples are taken during various stages of manufacturing to monitor the process and identify any deviations from the expected quality.

Analytical Testing:

Identity Testing: Confirm the identity of raw materials and finished products through methods such as chromatography, spectroscopy, and mass spectrometry.

Purity Testing: Assess the purity of substances to ensure they meet established criteria.

Potency Testing: Determine the concentration of the active ingredient to ensure it is within the specified range.

Microbiological Testing: Check for the presence of microorganisms to ensure product safety.

Stability Testing: Evaluate the stability of products under various conditions over time.

Quality Assurance Checks:

Batch Release: Quality assurance personnel review all relevant documentation and test results before releasing a batch for distribution.

Documentation Review: Ensure that all manufacturing and testing activities are properly documented and meet Good Documentation Practices (GDP).

Compliance with Good Manufacturing Practices (GMP):

Ensure that all manufacturing processes and testing activities comply with GMP regulations to maintain a high level of quality and consistency.

Regularly audit and inspect facilities to identify and rectify any deviations from GMP standards.

Equipment Calibration and Maintenance:

Regularly calibrate and maintain all equipment used in the manufacturing and testing processes to ensure accuracy and reliability.

Out-of-Specification (OOS) Investigations:

Investigate any out-of-specification results to determine the root cause and take corrective actions.

Training and Qualification:

Provide ongoing training to personnel involved in quality control activities to ensure they are knowledgeable about current standards and procedures.

Ensure that personnel are qualified and have the necessary skills to perform their roles effectively.

Change Control:

Implement a change control process to assess and manage any changes to manufacturing processes, equipment, or analytical methods that may impact product quality.

Continuous Improvement:

Regularly review and assess the effectiveness of the quality control process, identifying areas for improvement and implementing corrective and preventive actions.

Regulatory Compliance:

Stay updated on regulatory requirements and ensure that all quality control processes align with local and international regulations.

By implementing a robust quality control process, pharmaceutical companies can ensure the production of high-quality, safe, and effective products that meet regulatory standards. It also helps in building trust with regulatory authorities and consumers.