The Ultimate Resource for Pharmaceutical SOPs and Best Practices
To define the procedure for automated granule sampling during the continuous manufacturing process of tablets, ensuring representative and accurate sampling for quality control and process monitoring.
Click to read the full article.
To define the procedure for reviewing and approving batch records in tablet manufacturing, ensuring that all relevant data, processes, and approvals are documented and compliant with regulatory requirements before proceeding with production.
Click to read the full article.
To define the procedure for managing deviations that occur during tablet production, ensuring that all deviations are documented, investigated, and resolved in compliance with GMP and quality standards.
Click to read the full article.
To define the procedure for managing changes to tablet manufacturing processes, ensuring that all changes are properly documented, evaluated, and approved to maintain compliance with GMP and regulatory requirements.
Click to read the full article.
To establish a procedure for the training of personnel involved in tablet manufacturing, ensuring that all employees are competent and qualified to perform their duties in compliance with GMP and regulatory requirements.
Click to read the full article.
To establish procedures for the control and management of documentation in tablet manufacturing units, ensuring compliance with regulatory requirements and Good Manufacturing Practices (GMP).
Click to read the full article.
To define the procedures for monitoring and maintaining the cleanliness and classification of cleanrooms in the tablet manufacturing facility, ensuring that the environment meets regulatory requirements and GMP standards.
Click to read the full article.
Annexure-5: Cleaning Log Cleaning Date Area Cleaned Cleaning Personnel Cleaning Agent Used Remarks 01/01/2026 Production Area 1 John Doe Disinfectant X Cleaned according to SOP 02/01/2026 Packaging Area Jane Smith Disinfectant Y Minor debris removed Annexure-6: Cleanroom Record Retention Log Document Type Retention Period Storage Location Record Retention End Date Responsible Person Cleanroom Classification Record…
To establish the procedures for vendor qualification to ensure that raw materials used in tablet manufacturing meet the required quality standards, comply with GMP, and are safe for use in pharmaceutical production.
Click to read the full article.
To establish procedures for the calibration of critical equipment used in tablet manufacturing, ensuring that equipment performs according to required specifications and that the tablets produced meet quality and regulatory standards.
Click to read the full article.