Tag: Capsule Quality Control

Capsule Formulation: SOP for Content Uniformity Testing

SOP for Content Uniformity Testing Guidelines for Conducting Content Uniformity Tests 1) Purpose The purpose of this SOP is to provide guidelines for conducting content uniformity tests to ensure that the active ingredient is evenly distributed among capsules. 2) Scope This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that require content…

Capsule Formulation

SOP for Actions to Be Taken if Weight Variation Exceeds Acceptable Limits

SOP for Actions to Be Taken if Weight Variation Exceeds Acceptable Limits Procedures for Addressing Weight Variation Issues 1) Purpose The purpose of this SOP is to outline the actions to be taken when the weight variation of filled capsules exceeds acceptable limits, including documentation and investigation procedures. 2) Scope This SOP applies to all…

Capsule Formulation

SOP for Criteria for Determining Acceptable Weight Variation

SOP for Criteria for Determining Acceptable Weight Variation Guidelines for Acceptable Weight Variation 1) Purpose The purpose of this SOP is to establish criteria for determining acceptable weight variation in filled capsules to ensure uniformity and quality in the final product. 2) Scope This SOP applies to all filled capsules produced within the pharmaceutical manufacturing…

Capsule Formulation

SOP for Weight Variation Control

SOP for Weight Variation Control Procedure for Checking Weight of Filled Capsules 1) Purpose The purpose of this SOP is to establish a procedure for periodically checking the weight of filled capsules to ensure consistency within specified limits and maintain product quality. 2) Scope This SOP applies to the weight control of all filled capsules…

Capsule Formulation

SOP for Raw Material Release

SOP for Raw Material Release Procedures for Inspecting and Releasing Raw Materials 1) Purpose The purpose of this SOP is to establish procedures for inspecting and releasing raw materials for use in manufacturing based on predefined criteria to ensure quality and compliance. 2) Scope This SOP applies to all raw materials received and used in…

Capsule Formulation

SOP for Resampling and Retesting

SOP for Resampling and Retesting Procedures for Resampling and Retesting 1) Purpose The purpose of this SOP is to provide clear guidelines for resampling and retesting materials or products when initial results are questionable or invalidated to ensure the accuracy and reliability of test results. 2) Scope This SOP applies to all instances where initial…

Capsule Formulation

SOP for Sampling and Testing

SOP for Sampling and Testing Guidelines for Representative Sampling and Testing 1) Purpose The purpose of this SOP is to outline the standardized procedures for taking representative samples of materials and products for testing and analysis to ensure their quality and compliance with specifications. 2) Scope This SOP applies to all raw materials, in-process materials,…

Capsule Formulation

SOP for Quality Control Testing: Specific Procedures for Testing Capsules Using Analytical Instruments

SOP for Quality Control Testing: Specific Procedures for Testing Capsules Using Analytical Instruments 1) SOP for Quality Control Testing 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to provide specific procedures for conducting quality control testing of capsules using analytical instruments such as HPLC (High-Performance Liquid Chromatography), spectrophotometers, and dissolution testers. 3)…

Capsule Formulation

SOP for Environmental Monitoring: Guidelines for Monitoring and Recording Environmental Conditions in the Manufacturing Area

SOP for Environmental Monitoring: Guidelines for Monitoring and Recording Environmental Conditions in the Manufacturing Area 1) SOP for Environmental Monitoring 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and recording environmental conditions in the manufacturing area to ensure compliance with regulatory requirements and maintain product quality….

Capsule Formulation

SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-Conformances

SOP for Handling of Deviations and Incidents: Procedures for Identifying, Documenting, and Investigating Deviations, Incidents, or Non-Conformances 1) SOP for Handling of Deviations and Incidents 2) Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines and procedures for identifying, documenting, investigating, and resolving deviations, incidents, or non-conformances that occur during the…

Capsule Formulation