The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to outline the steps for ensuring Quality Assurance (QA) involvement in the validation of tablet packaging lines. This SOP ensures that the packaging lines are validated to meet the required standards for product integrity, regulatory compliance, and operational efficiency.
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The purpose of this SOP is to define the procedure for managing rework and reprocessing of tablet batches. This ensures that any batch that does not meet specifications can be safely reprocessed or reworked, adhering to quality standards and regulatory requirements.
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The purpose of this SOP is to establish the procedure for validating computerized systems used in Quality Assurance (QA). The goal is to ensure that all computerized systems used for data collection, analysis, and reporting comply with regulatory requirements and industry standards, such as 21 CFR Part 11.
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The purpose of this SOP is to establish a consistent approach for ensuring regulatory compliance during stability studies for tablet products. This SOP outlines the steps necessary to ensure that stability studies meet international regulatory requirements, including those set by the FDA, ICH, and other regulatory bodies.
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The purpose of this SOP is to outline the process for reviewing cleaning records for equipment and facilities used in tablet manufacturing. It ensures that all cleaning activities are documented, performed correctly, and comply with GMP guidelines to prevent cross-contamination and ensure product safety.
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The purpose of this SOP is to ensure that all in-process controls used in the manufacturing of tablets are approved by the Quality Assurance (QA) team. It ensures that all processes meet the required standards for consistency, quality, and regulatory compliance.
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The purpose of this SOP is to provide clear instructions for setting up and operating the tablet packing line in compliance with GMP guidelines. This ensures that the packing process is performed accurately, efficiently, and in a controlled environment to meet quality standards.
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This SOP provides the procedure for blister packing of immediate release tablets to ensure consistent and reliable packaging of the tablets in accordance with GMP standards. The goal is to ensure proper sealing, labeling, and packaging to maintain the integrity and quality of the tablets.
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The purpose of this SOP is to provide instructions for the strip packing of coated tablets, ensuring compliance with GMP standards. This SOP covers the setup, operation, and inspection of the strip packing machine, ensuring proper sealing, labeling, and packaging to maintain the quality and integrity of the tablets.
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This SOP describes the process for monitoring and controlling humidity levels during tablet packing to ensure the integrity of the packed product. Proper humidity control during packing ensures that the tablets do not degrade, preventing issues such as moisture-related defects or packaging failure.
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