Compressed air is used in the different areas of the pharmaceutical manufacturing facility. Compressed air may contain contaminants those may cause contamination in the pharmaceutical products. Therefore validation of compressed air is necessary to produce quality products.
Three Consecutive Batches for Validation in Pharmaceuticals
This is a common concept to validate three consecutive batches in pharmaceuticals. In process validation, initial three batches are taken for validation. This is a basic question that concentrates everyone’s mind that why three batches are taken for validation?
Qualification Procedure for Vial Washing Machine
Sterile pharmaceutical preparations as injections are filled in glass vials. These vials should be cleaned properly before filling. Automatic vial washing machines are used to clean but the process of cleaning of the vials should be validated. The efficiency of these machines is verified by following tests.
HPLC System Software Validation Plan
Introduction
Softwares are used to operate and interpret the analysis results in HPLC systems. There are many softwares those are used in different HPLC systems. All softwares are required to validate to ensure the accuracy of the produced data.
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
Software Validation is a requirement of GxP system. This software validation is intended to provide details of activities carried out and results therei…
NOEL and MACO Calculations in Cleaning Validation
NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined
to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. NOEL
is the amount of drug in mg that does not have any effect on the human health.
Purpose of Process Validation in Pharmaceuticals
The kind of effort expended for Process Validation is largely determined by organizational structure. Whether Process Validation is managed by a department, a consultant, or a committee, the criteria for the program are still the same. These criteria will be examined by the responsible individuals so that the program will be tailored to the character of the process under study. The following ques…
Recovery Factor Determination in Cleaning Validation
It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipment. Recovery factor is the recovery of swabbed material from the equipment to the solution.
Sampling in Cleaning Validation in Pharmaceutical Industry
Sampling in cleaning validation in the pharmaceutical industry has been a topic of ever-increasing interest and scrutiny in recent Food and Drug Administration (FDA) inspections. The validation of procedures used to clean the equipment employed during the various steps of a manufacturing process is a clear requirement of current Good Manufacturing Practice (cGMP). Such as, FDA inspectors now expe…
Cleaning Validation of Clean-in-Place (CIP) Systems
The clean-in-place cleaning method is used to clean equipment that can not be disassembled or displaced like pipelines, tanks and large vessels. Cleaning validation ensures that our cleaning method is capable of removing the residues and contaminants from the equipment or vessel. Cleaning validation of such equipment as great importance because we can not move them for proper cleaning and some pa…
Importance of Validation in Pharmaceuticals
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in the United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is a very common concept in the pharmaceutical industries throughout the world.
Regulatory Expectations from Cleaning Validation
Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product if it is not cleaned properly. Improperly cleaned manufacturing equipment is a major source of cross-contamination. Regulatory agencies are more concerned about the cross-contamination of penicillin with non-penicillin products.
How to Effectively Execute a Validation Protocol?
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
How to Write a Validation Master Plan?
A Validation Master Plan (also referred to as the VMP) is a document which outlines the principles tied to the qualification of a certain facility, defining the systems and areas which need validation and provides a written guideline on how to achieve and then maintain a qualified facility. VMP is basically a summary of the validation strategy. It is a crucial segment of Good Manufacturing Practi…
Revalidation of Equipment and Process in Pharmaceuticals
Revalidation in the pharmaceutical industry is very important as it helps to maintain the validated status of the equipment, plant, manufacturing process as well as the computer systems. This procedure is necessary for periodic checking of the validation results according to the revalidation period.
Alarm Challenge Test in Pharmaceuticals
The alarm challenge test in pharmaceuticals is very important as it ensures that everything is in working order, hence preventing accidents and other hazards. Safety concerns take the front seat in pharmaceuticals, in large part because the industry deals with the manufacture of medicines consumed by patients. The alarm challenge test in pharmaceuticals is intended to ensure that the systems and…
Steps for HPLC Method Validation
In the pharmaceutical industry, validation is an essential part of quality control and quality assurance. Various regulatory authorities give particular emphasis on the validation of all the processes used in the industry. Validation is a formal and systematic way to demonstrate the suitability of the assay method to provide useful data to ensure that the process or the technique gives satisfacto…
Design Qualification (DQ) of Equipment
Design qualification is defined as a verification process on the design to meet particular requirements relating to the quality of pharmaceuticals and manufacturing practices. However, the procedure for design qualification in pharmaceuticals is one reason as to why some products do not make it to the shelves in drugstores.
Performance Qualification (PQ) of Pharmaceutical Equipment
When you subscribe to a new internet plan, you tend to check the download speed by downloading something in order to verify if you are receiving the promised data rate. But are the data rates consistent throughout the day? Do you get the same speed if another device is also connected to the network? These are the kind of questions that are answered by performance qualification.
Operational Qualification (OQ) in Pharmaceuticals
Operational Qualification, or OQ, is an essential process during the development of equipment often used by pharmaceutical companies. OQ can simply be defined as a series of tests which ensure that equipment and its sub-systems will operate within their specified limits consistently and dependably.
Installation Qualification (IQ) in Pharmaceuticals
Installation Qualification (IQ) is ascertaining that all the important aspects of process equipment together with ancillary system installation follow the approved specification of a manufacturer and what the supplier recommends. An equipment has to be installed by trained personnel according to the drawings and specifications provided.
Validation of Fumigation in Cleanroom Area
Fumigation is the process to disinfect the sterile manufacturing and microbiology testing area. Generally, fumigation is not required when AHU runs continuously but when the microbial load increases in the controlled area it is controlled and minimized by fumigation of the area.
Revalidation of Pharmaceutical Processes
Revalidation of any process is an essential part of the validation. It improves the quality of the product and increases the smoothness of the process. There are various conditions in which it is essential to revalidate the process. Revalidation is done in two conditions. A. Periodic Revalidation B. Revalidation after any change
Validation of the Effectiveness of UV Light in Water System
UV radiation is an important component when it comes to the control of microbial contamination. To ensure the efficiency of UV light in purified water is kept at optimum, most of the time, validation of effective working of UV light in pharmaceutical water system needs to be carried out.
Media Fill Test for Sterile API Manufacturing Process
Media fill test is done to verify the sterility of the sterile manufacturing process. Media fill validation for sterile API is different from the sterile formulation media fill.
How to Write a Validation Protocol?
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Writing Effective SOPs in Pharmaceuticals
Standard operating procedures are back bone of a pharmaceutical manufacturing company. These are essential to produce effective and quality products consistently. But writing an effective, easy to understand and meeting the regulatory requirements SOP is not an easy task.
Detergents Used for Cleaning of Pharmaceutical Equipment
Cleaning is an important part of pharmaceutical manufacturing to manufacture contamination-free quality products. Facility cleaning and sanitization is an important part of GMP compliance. In this post, we will explore the importance and use of detergents used in the cleaning of pharmaceutical equipment used in manufacturing.
Why is Analytical Method Validation Required?
Analytical method validation is documented evidence that any analytical method used for the analysis of any product is suitable, reliable and produces consistent results. We can say that a validated analytical method produces reliable and authentic results.
Basics of HVAC System and Its Components
Air conditioning has changed over the years, the HVAC system is used to control the environment in the manufacturing as well as the storage area of the pharmaceutical facility. Maintenance of area and air quality by filtration and temperature and humidity is controlled by using an HVAC system.
Film Coating Process in Pharmaceuticals
Film Coating Process
Film coating process plays a very important role in film coating and a number of problems in tablet coating are related to process setup. There is a number of variables which should be controlled in a process and we will understand how these variables are crucial for the film coating process. We will also study various kinds of equipment, which are available for film coating…
