The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define a systematic procedure for developing and executing line clearance checks prior to initiating analytical activities in the Analytical Method Development (AMD) laboratory to avoid mix-ups, cross-contamination, and non-compliance.
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To define the procedure for evaluating recovery factors from spiked surfaces as part of cleaning validation, which ensures the accuracy and reliability of swab and rinse sampling results used to confirm cleanliness of pharmaceutical manufacturing equipment.
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To define the procedure for conducting spray droplet size distribution analysis in nasal sprays or inhalation formulations using validated instrumentation to assess drug delivery performance and consistency.
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To define the standardized procedure for performing Delivered Dose Uniformity (DDU) testing of nasal sprays, metered-dose inhalers (MDIs), and other unit-dose aerosol products to ensure dose consistency within and between units.
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To define the procedure for developing and validating a method to evaluate the mechanical and functional performance of nasal spray pumps, including delivered volume, actuation force, spray weight, and spray pattern.
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To describe the procedure for evaluating the priming and repriming characteristics of nasal spray and inhalation delivery systems to ensure dose accuracy after initial activation and re-use following storage or interruption.
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To define a standardized method for evaluating the plume geometry of nasal spray and metered-dose inhaler (MDI) products in order to ensure consistency in drug delivery, device performance, and regulatory compliance.
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To define the procedure for developing and executing a validated method for plume geometry analysis of nasal spray pumps and metered-dose inhalers (MDIs) using visual capture and image processing techniques, ensuring reproducibility and conformance to design specifications.
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To establish a validated HPLC-based analytical method for quantifying the content of the active pharmaceutical ingredient (API) in individual spray actuations from nasal or oral sprays to ensure dose uniformity and compliance with regulatory requirements.
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To define the procedure for the identification, quantification, and reporting of organic impurities in nasal spray formulations using High Performance Liquid Chromatography (HPLC) in compliance with ICH Q3B(R2) and pharmacopeial standards.
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