Tag: Temperature mapping in storage areas

SOP for Personal Protective Equipment (PPE) Usage

SOP for Personal Protective Equipment (PPE) Usage Standard Operating Procedure for Personal Protective Equipment (PPE) Usage 1) Purpose The purpose of this SOP is to establish guidelines for the proper selection, use, and maintenance of personal protective equipment (PPE) to ensure personnel safety during pharmaceutical manufacturing operations. 2) Scope This SOP applies to all personnel…

Injectables

SOP for Sterilization Procedures for Manufacturing Equipment

SOP for Sterilization Procedures for Manufacturing Equipment Standard Operating Procedure for Sterilization Procedures for Manufacturing Equipment 1) Purpose The purpose of this SOP is to establish guidelines for the sterilization of manufacturing equipment to ensure microbial control and product quality in pharmaceutical manufacturing. 2) Scope This SOP applies to all personnel involved in the sterilization…

Injectables

SOP for Quality Control Testing of IV Injections

SOP for Quality Control Testing of IV Injections Standard Operating Procedure for Quality Control Testing of IV Injections 1) Purpose The purpose of this SOP is to define the procedures for quality control testing of intravenous (IV) injections to ensure they meet specifications for safety, efficacy, and quality. 2) Scope This SOP applies to all…

Injectables

SOP for Handling Deviations during Manufacturing

SOP for Handling Deviations during Manufacturing Standard Operating Procedure for Handling Deviations during Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for identifying, documenting, evaluating, and managing deviations from established manufacturing processes to ensure product quality and compliance. 2) Scope This SOP applies to all personnel involved in manufacturing operations within…

Injectables

SOP for Training of Personnel in Aseptic Manufacturing

SOP for Training of Personnel in Aseptic Manufacturing Standard Operating Procedure for Training of Personnel in Aseptic Manufacturing 1) Purpose The purpose of this SOP is to establish procedures for the training and qualification of personnel involved in aseptic manufacturing processes to ensure competency and adherence to aseptic techniques. 2) Scope This SOP applies to…

Injectables

SOP for Documentation and Record Keeping in Manufacturing

SOP for Documentation and Record Keeping in Manufacturing Standard Operating Procedure for Documentation and Record Keeping in Manufacturing 1) Purpose The purpose of this SOP is to establish guidelines for the documentation and recordkeeping practices in pharmaceutical manufacturing to ensure accuracy, traceability, and compliance with regulatory requirements. 2) Scope This SOP applies to all personnel…

Injectables

SOP for Storage Conditions for Finished Products

SOP for Storage Conditions for Finished Products Standard Operating Procedure for Storage Conditions for Finished Products 1) Purpose The purpose of this SOP is to define the procedures for the storage of finished pharmaceutical products to maintain their integrity, stability, and quality throughout the storage period. 2) Scope This SOP applies to all personnel involved…

Injectables

SOP for Visual Inspection of Finished Products

SOP for Visual Inspection of Finished Products Standard Operating Procedure for Visual Inspection of Finished Products 1) Purpose The purpose of this SOP is to establish procedures for the visual inspection of finished pharmaceutical products to ensure they meet quality standards before release for distribution. 2) Scope This SOP applies to all personnel involved in…

Injectables

SOP for Cleaning Validation in Manufacturing Area

SOP for Cleaning Validation in Manufacturing Area Standard Operating Procedure for Cleaning Validation in Manufacturing Area 1) Purpose The purpose of this SOP is to define the procedures for cleaning validation in the pharmaceutical manufacturing area to ensure removal of residues and contaminants from equipment and surfaces. 2) Scope This SOP applies to all cleaning…

Injectables

SOP for Gowning Procedures in Cleanroom Environment

SOP for Gowning Procedures in Cleanroom Environment Standard Operating Procedure for Gowning Procedures in Cleanroom Environment 1) Purpose The purpose of this SOP is to define the procedures for gowning in a cleanroom environment to prevent contamination of pharmaceutical products and ensure compliance with cleanliness standards. 2) Scope This SOP applies to all personnel entering…

Injectables