Various analytical methods are utilized to determine the efficacy and safety of the given drug compound for its intended use. These methods provide the optimal information required for successful drug product development and market release. However, it is imperative to verify these procedures with the assistance of method validation, which is considered an important part of the good analytical practice. The results achieved from the test method validation is utilized to predict the reliability, quality, and consistency of the drug product.
The analytical method validation is a significant aspect of the manufacturing process of a new drug compound. These analytical method validations verify methods that are useful for determining selectivity, stability, accuracy, linearity, and precision of the drug candidates.
This article will discuss the role of quality control in pharmaceutical method validation.
Pharmaceutical Quality Control
The term quality control of drugs refers to all the methods involved in the drug discovery and development utilized to ensure purity and identity of certain pharmaceutical drugs, both in dosage and active forms. These analytical methods identify and assess the pharmaceutical drug compound, its potency (which is 9-110%), shape, colour uniformity, dosage size, stability, and bioavailability.
The quality control in method validation is essential to understand and assure the safety and effectiveness of the given drug product. The method validation QC measurements involve the stability of the formulation of the drug, raw material analysis, and dissolution testing.
Although quality control is the general term employed, there are two subdivisions, quality assurance and quality control.
Quality assurance indicates the formation of a system that assures the safety of developing pharmaceutical methods. According to the system of method validation, all the pharmaceutical products should adhere to certain quality standards and its effectiveness should be acceptable to the patients. It is believed that following a systematic approach aids the quality assurance system by allowing appropriate storage, monitoring, distribution, and proper usage by customers through necessary guidelines.
Every activity or method that assesses the safety of the drug compound requires quality control in various stages. From acquiring raw material until the time drug products reach the market, thorough method validations are formed and utilized for quality control. This ensures production of consistent, quality drug products which are appropriate for the designated use.
Quality control in method validation involves various aspects:
• Safety and efficacy of active ingredients.
• Quality standards of the material by providers.
• Quality standards of the active ingredients in the dosage form is maintained.
• The packaging is devised to prevent degradation.
• Optimal storage of ingredients and drug products.
• Adequate and safe transportation.
Remember, quality control in method validation is necessary as low-quality drug products can decrease or completely eliminate the therapeutic impact of the drug compounds on the illness or disease. The toxicological properties of the drug product change with reduced quality and this can cause harm to the human body rather than stimulating a healing effect. Hence, controlling the quality of analytical methods and developing relevant validations is an essential aspect of drug discovery and development.