Author: Auditor

Capsule Formulation: SOP for Documentation and Record-Keeping

Standard Operating Procedure for Documentation and Record-Keeping Purpose The purpose of this SOP is to establish procedures for the systematic and accurate documentation and record-keeping in pharmaceutical manufacturing, ensuring compliance with regulatory standards and maintaining data integrity. Scope This SOP applies to all personnel involved in the manufacturing and quality control of pharmaceutical products, including operators,…

Capsule Formulation

SOP Vendor Data Integrity

Standard Operating Procedure Vendor Data Integrity Purpose The purpose of this SOP is to establish procedures for ensuring the integrity of data received from vendors within the pharmaceutical manufacturing facility. This includes data related to raw materials, components, and services supplied by external vendors. Scope This SOP applies to all personnel involved in the procurement,…

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Data Integrity

SOP for Sampling and Retention of Samples

Standard Operating Procedure for Sampling and Retention of Samples Purpose The purpose of this SOP is to establish procedures for the systematic and accurate sampling of raw materials, in-process materials, and finished products, as well as the retention of representative samples for further analysis and future reference. Scope This SOP applies to all personnel involved in…

Capsule Formulation

SOP for Vacuum Conveyor Operation

Standard Operating Procedure for Vacuum Conveyor Operation Purpose The purpose of this SOP is to establish procedures for the safe and efficient operation of the vacuum conveyor system, ensuring proper material handling, cleanliness, and compliance with regulatory standards. Scope This SOP applies to all personnel involved in the operation and maintenance of the vacuum conveyor,…

Capsule Formulation

Standard Operating Procedure for Data Integrity Training Program

Standard Operating Procedure for Data Integrity Training Program Purpose The purpose of this SOP is to establish procedures for the implementation and management of a Data Integrity Training Program within the pharmaceutical manufacturing facility. This program aims to educate personnel on the principles of data integrity, regulatory requirements, and best practices to ensure the accuracy and…

Data Integrity

SOP for Inkjet or Laser Coding Process

Standard Operating Procedure for Inkjet or Laser Coding Process Purpose The purpose of this SOP is to establish procedures for the accurate and consistent coding of pharmaceutical products using inkjet or laser coding technology, ensuring compliance with regulatory standards and product traceability. Scope This SOP applies to all personnel involved in the inkjet or laser…

Capsule Formulation

SOP for Coating Process

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

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Quality Assurance

SOP for Data Quality Metrics

Standard Operating Procedure for Data Quality Metrics Purpose The purpose of this SOP is to establish procedures for the systematic measurement and assessment of data quality within the pharmaceutical manufacturing facility. This ensures the accuracy, completeness, and reliability of electronic data used for decision-making and regulatory compliance. Scope This SOP applies to all personnel involved in…

Data Integrity

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