The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this Standard Operating Procedure (SOP) is to establish a structured approach for data archiving, ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal data retention policies. Proper data archiving safeguards critical records and maintains data integrity for audits and inspections.
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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for recording and maintaining environmental monitoring data in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP) and regulatory guidelines, ensuring a controlled manufacturing environment.
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The purpose of this Standard Operating Procedure (SOP) is to define a structured approach for the storage, handling, and documentation of retained samples in pharmaceutical manufacturing. Retained samples serve as reference materials to verify batch quality, support investigations, and meet regulatory compliance requirements.
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The purpose of this Standard Operating Procedure (SOP) is to establish a standardized approach for preparing Annual Product Quality Reviews (APQR) in pharmaceutical manufacturing. The APQR evaluates the consistency of a product’s quality, identifies trends, and ensures compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for documenting training records of personnel in pharmaceutical manufacturing. Accurate training records ensure regulatory compliance, competency verification, and continual professional development.
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The purpose of this Standard Operating Procedure (SOP) is to establish a standardized process for recording, verifying, and filing in-process control (IPC) data in pharmaceutical manufacturing. Proper documentation ensures regulatory compliance, traceability, and product quality throughout the production process.
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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for managing change control records in pharmaceutical manufacturing. Change control ensures that all proposed changes to processes, equipment, documents, and materials are evaluated, approved, and documented before implementation to maintain compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for recording and investigating non-conformance reports (NCRs) in pharmaceutical manufacturing. Proper documentation and investigation of non-conformances ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements while maintaining product quality.
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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic method for documenting calibration activities in pharmaceutical manufacturing. Proper documentation ensures compliance with Good Manufacturing Practices (GMP), regulatory requirements, and equipment reliability for accurate measurements.
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The purpose of this Standard Operating Procedure (SOP) is to establish a systematic approach for preparing, reviewing, approving, and maintaining SOPs within pharmaceutical manufacturing. SOPs ensure standardization of processes, regulatory compliance, and effective training of personnel.
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