The Ultimate Resource for Pharmaceutical SOPs and Best Practices
SOP for Training of Manufacturing Personnel Standard Operating Procedure for Training of Manufacturing Personnel 1) Purpose The purpose of this SOP is to establish procedures for the training of manufacturing personnel to ensure they are qualified and competent to perform their assigned tasks. 2) Scope This SOP applies to all personnel involved in the training…
SOP for Documentation and Record Keeping Standard Operating Procedure for Documentation and Record Keeping 1) Purpose The purpose of this SOP is to establish procedures for the creation, maintenance, and retention of documentation and records to ensure accuracy, integrity, and regulatory compliance. 2) Scope This SOP applies to all personnel involved in documentation and record…
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SOP for Change Control Management Standard Operating Procedure for Change Control Management 1) Purpose The purpose of this SOP is to establish procedures for managing changes to processes, equipment, documents, and systems to ensure that changes are controlled and documented. 2) Scope This SOP applies to all personnel involved in change control management at [Company…
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SOP for Handling of Deviations Standard Operating Procedure for Handling of Deviations 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, investigating, and resolving deviations from standard processes to ensure product quality and compliance. 2) Scope This SOP applies to all personnel involved in handling deviations at [Company Name] in…
SOP for Preventive Maintenance of Equipment Standard Operating Procedure for Preventive Maintenance of Equipment 1) Purpose The purpose of this SOP is to establish procedures for the preventive maintenance of manufacturing equipment to ensure optimal performance and minimize equipment downtime. 2) Scope This SOP applies to all personnel involved in the preventive maintenance of equipment…
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SOP for Equipment Calibration Standard Operating Procedure for Equipment Calibration 1) Purpose The purpose of this SOP is to establish procedures for the calibration of manufacturing equipment to ensure accuracy and reliability in production processes. 2) Scope This SOP applies to all personnel involved in the calibration of equipment at [Company Name] used for the…
SOP for Cleaning Validation Standard Operating Procedure for Cleaning Validation 1) Purpose The purpose of this SOP is to establish procedures for validating the cleaning processes of manufacturing equipment to ensure they consistently remove residues to acceptable levels. 2) Scope This SOP applies to all personnel involved in cleaning validation at [Company Name] for the…
SOP for Cold Chain Management Standard Operating Procedure for Cold Chain Management 1) Purpose The purpose of this SOP is to establish procedures for managing the cold chain to ensure the integrity and quality of temperature-sensitive injection products. 2) Scope This SOP applies to all personnel involved in the cold chain management of finished products…
SOP for Storage of Finished Products Standard Operating Procedure for Storage of Finished Products 1) Purpose The purpose of this SOP is to define the procedures for the proper storage of finished injection products to maintain their quality and integrity. 2) Scope This SOP applies to all personnel involved in the storage of finished products…
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SOP for Batch Release Procedures Standard Operating Procedure for Batch Release Procedures 1) Purpose The purpose of this SOP is to establish the procedures for the release of manufactured batches of injection products to ensure they meet all quality and regulatory requirements. 2) Scope This SOP applies to all personnel involved in the batch release…