Author: Auditor

Capsule Formulation: SOP for Material Handling

Standard Operating Procedure for Material Handling Purpose The purpose of this SOP is to establish procedures for the proper handling, storage, and transportation of materials within the pharmaceutical facility, ensuring the integrity, safety, and traceability of materials throughout the supply chain. Scope This SOP applies to all personnel involved in material handling, including warehouse staff,…

Capsule Formulation

SPO for Environmental Monitoring

Standard Operating Procedure for Environmental Monitoring Purpose The purpose of this SOP is to establish procedures for monitoring and maintaining the environmental conditions within pharmaceutical manufacturing and storage areas to ensure compliance with regulatory standards and product quality. Scope This SOP applies to all personnel involved in environmental monitoring, including operators, technicians, and quality control…

Capsule Formulation

SOP for Batch Record Keeping

Standard Operating Procedure for Batch Record Keeping Purpose The purpose of this SOP is to establish procedures for the accurate and systematic documentation of batch records, ensuring traceability, compliance with regulatory standards, and maintaining a comprehensive record of each pharmaceutical product batch. Scope This SOP applies to all personnel involved in the batch record keeping…

Capsule Formulation

SOP for Data Review and Approval Workflow

Standard Operating Procedure for Data Review and Approval Workflow Purpose The purpose of this SOP is to establish procedures for the systematic review and approval of electronic data within the pharmaceutical manufacturing facility. This ensures data accuracy, integrity, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the generation, processing, and…

Data Integrity

SOP for Metal Detection Process

Standard Operating Procedure for Metal Detection Process Purpose The purpose of this SOP is to establish procedures for the effective use of metal detection equipment to ensure the detection and removal of metallic contaminants from pharmaceutical products, maintaining product safety and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the…

Capsule Formulation

SOP for Data Transfer Procedures

Standard Operating Procedure for Data Transfer Procedures Purpose The purpose of this SOP is to establish procedures for the secure and accurate transfer of electronic data within the pharmaceutical manufacturing facility. This ensures data integrity, confidentiality, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the generation, processing, and transfer of…

Data Integrity

SOP of Deblistering Process

Standard Operating Procedure for Deblistering Process Purpose The purpose of this SOP is to establish procedures for the safe and effective deblistering of pharmaceutical products, ensuring the recovery of intact tablets or capsules for quality control purposes. Scope This SOP applies to all personnel involved in the deblistering process, including operators, technicians, and quality control personnel….

Capsule Formulation

SOP for Labeling Process

Standard Operating Procedure for Labeling Process Purpose The purpose of this SOP is to establish procedures for the accurate and controlled labeling of pharmaceutical products, ensuring compliance with regulatory standards, and maintaining product traceability. Scope This SOP applies to all personnel involved in the labeling process, including operators, technicians, and quality control personnel. Responsibilities Operators: Responsible…

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Capsule Formulation

SOP for Bottle Filling and Capping Process

Standard Operating Procedure for Bottle Filling and Capping Process Purpose The purpose of this SOP is to establish procedures for the efficient and controlled filling and capping of bottles, ensuring accuracy, quality, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the bottle filling and capping process, including operators, technicians, and…

Capsule Formulation

SOP for Data Validation and Verification

Standard Operating Procedure for Data Validation and Verification Purpose The purpose of this SOP is to establish procedures for the systematic validation and verification of electronic data within the pharmaceutical manufacturing facility. This ensures the accuracy, reliability, and integrity of data used for decision-making and regulatory compliance. Scope This SOP applies to all personnel involved…

Data Integrity