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Tag: Validation

Cleaning Procedure Tools (Matrices) and Flow Chart

Cleaning Procedure Tools (Matrices) and Flow Chart

Pharma
We have discussed How to Sampling in Cleaning Validation in the Pharma and Cleaning Standard Operating Procedure in Pharma now we move further to Cleaning Procedure Tools (Matrices) and we have also updated the Cleaning Procedure Flowchart for better understanding to our valued visitors. You can read previous articles Sampling in Cleaning Validation as well as other Pharma knowledgeable articles name Cleaning Standard Operating Procedure in Pharmaceuticals. Now we move to our main topic. Cleaning Procedure Tools (Matrices) Tables, schemas, and matrices are the main tools used during the preparation of cleaning validation protocol and procedure, especially for multi-product areas and equipment. This will help cleaning procedure developers to determine the worst-case and to calculate by t...
Cleaning Standard Operating Procedure in Pharma (SOP)

Cleaning Standard Operating Procedure in Pharma (SOP)

Pharma
After reading our previous article about Sampling in Cleaning Validation in the Pharmaceutical now we move to another step of cleaning validation named Cleaning Standard Operating Procedure in Pharma. In this article, we try to cover all the essentials about the Objective, responsibilities, and other information. The standard cleaning operation procedure should include the following essential points: The objective of Cleaning Standard Operating Procedure The purpose of the study is to validate the analytical method for the determination of traces of API content in Swab & Rinse samples and to establish documented evidence and provide the procedure for the same. Scope Describe the range of applications for the SOP, equipment, and products. The scope should assess the acceptability o...
How to Sampling in Cleaning Validation in the Pharmaceutical – Step by Step

How to Sampling in Cleaning Validation in the Pharmaceutical – Step by Step

Pharma
Cleaning validation sampling in the pharmaceutical industry has been a subject of increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of the procedures used to clean the equipment used during the different steps of a manufacturing process is a clear requirement of current Good Manufacturing Practices (cGMP). For example, FDA inspectors now expect to see a cleanliness validation program in place with the proper documentation in place during their inspections. The objectives of this article are to establish a broad basis for sampling in cleaning method validation policies and programs and to determine the requirements, procedures, acceptance limits, and working documents necessary to support this critically important activity.   R...