Tag: Quality Control

In-Process Control: SOP for Tablet Hardness Testing

Standard Operating Procedure for Hardness Testing Purpose The purpose of this SOP is to define the procedures for conducting hardness testing during the tablet manufacturing process to ensure the mechanical strength and integrity of capsules. Scope This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for conducting hardness testing. Responsibilities…

In-Process Control

SOP for Granule Size Distribution

Standard Operating Procedure for Granule Size Distribution Purpose The purpose of this SOP is to define the procedures for determining granule size distribution during the tablet/ capsule manufacturing process to ensure product quality and consistency. Scope This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for assessing granule…

In-Process Control

In-Process Control: SOP for Blend Uniformity Testing

Standard Operating Procedure for Blend Uniformity Testing Purpose The purpose of this SOP is to outline the procedures for conducting blend uniformity testing during the tablet/ capsule manufacturing process to ensure homogeneity and consistency of the blend. Scope This SOP applies to all personnel involved in the tablet/ capsule manufacturing process, specifically those responsible for…

In-Process Control

In-Process Control: SOP for pH Testing

Standard Operating Procedure for pH Testing Purpose The purpose of this SOP is to outline the procedures for conducting pH testing during the tablet/ capsule manufacturing process to ensure the acidity or alkalinity of the tablets / capsule. Scope This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for pH…

In-Process Control

In-Process Control: SOP for Dissolution Testing

Standard Operating Procedure for Dissolution Testing Purpose The purpose of this SOP is to outline the procedures for conducting dissolution testing during the Capsule/ tablet manufacturing process to ensure proper release of the active pharmaceutical ingredient (API). Scope This SOP applies to all personnel involved in capsule/ tablet manufacturing, specifically those responsible for dissolution…

In-Process Control

SOP for Disintegration Testing of Tablets

Standard Operating Procedure for Tablet Disintegration Testing Purpose The purpose of this SOP is to outline the procedures for conducting disintegration testing during the tablet manufacturing process to ensure proper breakdown and dissolution of tablets. Scope This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for disintegration testing. Responsibilities Quality…

In-Process Control

SOP for in-process Weight Variation

Standard Operating Procedure for in-process Weight Variation Testing Purpose The purpose of this SOP is to outline the procedures for conducting weight variation testing during the tablet/ capsule manufacturing process to ensure uniformity and consistency of capsule/ tablet weight. Scope This SOP applies to all personnel involved in capsule/ tablet manufacturing, specifically those responsible…

In-Process Control

SOP for In-Process Friability Testing

Standard Operating Procedure for in-process Friability Testing Purpose The purpose of this SOP is to outline the procedures for conducting friability testing during the tablet manufacturing process to assess the durability and quality of tablets. Scope This SOP applies to all personnel involved in tablet manufacturing, specifically those responsible for friability testing. Responsibilities Quality Control…

In-Process Control

SOP for Determination of Moisture Content

Standard Operating Procedure for Moisture Content Determination in Manufacturing Purpose The purpose of this SOP is to outline the procedures for determining moisture content during the tablet manufacturing process to ensure product quality, stability, and compliance with regulatory requirements. Scope This SOP applies to all personnel involved in the tablet manufacturing process, particularly those…

In-Process Control

Raw Material Sampling Plan: Procedure for Water Sampling

The Raw Material Sampling Plan Procedure for Water outlined in this SOP is critical to ensuring the quality and safety of the water used in the manufacturing processes. By following this procedure, the company can ensure that all water used in the manufacturing processes meets the specified quality standards and does not pose any health…

Raw Material Stores