The Ultimate Resource for Pharmaceutical SOPs and Best Practices
This SOP defines the procedure for performing heavy metal testing on capsule materials to ensure that the levels of potentially toxic metals, such as lead, mercury, arsenic, and cadmium, do not exceed the acceptable limits.
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This SOP defines the procedure for conducting microbial limit testing on capsules to ensure that the product complies with microbiological standards and is safe for consumer use.
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To outline the procedure for performing assay testing on capsule fill materials to ensure that the active pharmaceutical ingredient (API) content meets the required specifications.
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The purpose of this SOP is to define the procedure for testing the uniformity of content in capsules. Uniformity of content ensures that each capsule contains the correct amount of active pharmaceutical ingredient (API), which is crucial for product efficacy, safety, and regulatory compliance. This SOP provides guidelines for performing uniformity of content testing to ensure consistency in every capsule produced.
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The purpose of this SOP is to define the procedure for performing weight variation testing on capsules. Capsule weight variation testing is critical for ensuring uniformity in the weight of capsules, which is essential for ensuring the correct dosage of the active pharmaceutical ingredients (APIs) and excipients. This SOP ensures that capsule weight meets the defined standards and complies with regulatory requirements.
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The purpose of this SOP is to define the procedure for visually inspecting capsule shells to ensure that they meet the required quality standards. Visual inspection is a critical step to detect defects such as cracks, chips, incomplete sealing, and foreign contamination, ensuring that only acceptable products proceed to the next stage of production.
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The purpose of this SOP is to establish the procedure for validating in-process testing during capsule manufacturing. In-process testing ensures that the manufacturing process consistently meets product quality standards. This SOP ensures that in-process tests are reliable, accurate, and suitable for monitoring critical quality attributes throughout the production process.
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The purpose of this SOP is to define the process for validating capsule packing operations to ensure that the packaging of capsules meets all quality, regulatory, and GMP requirements. The SOP ensures that the packing process maintains product integrity, ensures consistent weight and labeling, and complies with all regulatory standards.
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The purpose of this SOP is to establish a standardized procedure for validating the granulation processes used in capsule manufacturing. Granulation is a crucial step in the production of capsules as it affects the flow, uniformity, and compressibility of the material. This SOP ensures that the granulation process is performed consistently and meets the required quality standards.
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The purpose of this SOP is to establish the procedure for validating stability studies for capsules. Stability testing is essential to determine the shelf-life of capsules, ensuring their safety, efficacy, and quality over time. This SOP outlines the requirements for designing, conducting, and analyzing stability studies to meet regulatory requirements and GMP standards.
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