Tag: Capsule Batch Record

SOP for Disintegration Testing Guidelines for Performing Disintegration Tests 1) Purpose The purpose of this SOP is to provide guidelines for performing disintegration tests to determine how quickly capsules disintegrate in a specified liquid medium. 2) Scope This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that require disintegration testing. 3) Responsibilities…

Read More “Capsule Formulation: Capsule Formulation: SOP for Disintegration Testing” »

SOP for Actions to Be Taken if Content Uniformity is Out of Specification Procedures for Addressing Content Uniformity Issues 1) Purpose The purpose of this SOP is to outline the actions to be taken when content uniformity of capsules is found to be out of specification, including documentation and investigation procedures. 2) Scope This SOP…

Read More “SOP for Actions to Be Taken if Content Uniformity is Out of Specification” »

SOP for Criteria for Determining Acceptable Content Uniformity Guidelines for Acceptable Content Uniformity 1) Purpose The purpose of this SOP is to establish criteria for determining acceptable content uniformity in capsules to ensure the even distribution of the active ingredient. 2) Scope This SOP applies to all capsules produced within the pharmaceutical manufacturing facility that…

Read More “SOP for Criteria for Determining Acceptable Content Uniformity” »

SOP for Sampling Procedures for Content Uniformity Tests Procedures for Sampling Capsules for Content Uniformity Testing 1) Purpose The purpose of this SOP is to outline the sampling procedures for selecting capsules for content uniformity tests to ensure a representative and unbiased sample. 2) Scope This SOP applies to the sampling of all capsules produced…

Read More “SOP for Sampling Procedures for Content Uniformity Tests” »

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…

Read More “Capsule Formulation: SOP for Content Uniformity Testing” »

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…

Read More “SOP for Actions to Be Taken if Weight Variation Exceeds Acceptable Limits” »

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…

Read More “SOP for Criteria for Determining Acceptable Weight Variation” »

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…

Read More “SOP for Weight Variation Control” »

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…

Read More “SOP for Raw Material Release” »

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…

Read More “SOP for Resampling and Retesting” »