Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals

1.0 OBJECTIVE1.1  To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment.
2.0 SCOPE2.1  This procedure applies to all aseptically filled sterile products intended for human use.
3.0 RESPONSIBILITY3.1  The Validation personnel coordinate the aseptic filling validation program …

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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.

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Purified Water System Validation

Water system validation (generation and distribution) should contain three phases: Phase I: investigation phase; Phase II: short-term control; and Phase III: long-term control.
The objective of pharmaceutical water system validation during these three phases should demonstrate that water system is under control and producing the specified quality of water over a long time period.
Related: Reverse…

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Process Validation in Pharmaceutical Manufacturing

1. IntroductionValidation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows: • Quality, safety and efficacy must be desi…

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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…

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System Suitability in HPLC Analysis

HPLC, short for High-performance liquid chromatography is a technique used for separating the components in a mixture. In the HPLC technique, a liquid sample is passed over an absorbent material to test its efficacy.
HPLC chromatography technique is used in pharmaceutical industries for research and testing purposes. Most of the pharmaceutical companies follow a three-step approach to check the f…

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Difference Between Dynamic and Static Pass Box

In pharmaceutical manufacturing industries, pass boxes are normally used to transfer a particular material between two areas generally of different cleanliness levels. The boxes can be said to transfer the materials from a high level of cleanliness to a lower level of cleanliness or vice-versa. The pass boxes while transferring the material, help to prevent air from flowing from one area to anoth…

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Different Types of HPLC Detectors

HPLC detectors are used in the detection of the solute present in the eluent coming from the HPLC column. They are capable of determining the identity and concentration of eluting compounds in the mobile phase. There are specific detectors which respond to a specific compound and their response is not dependent on mobile phase composition.

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Concept of GxP in Pharmaceuticals

One of the biggest concerns that the pharmaceutical industry constantly attempts to address is the safety of its products. GxP is a collection of regulations that aim to resolve this matter in a systematic and wholesome manner. The concept of GxP requirements in Pharmaceuticals was established by the United States Food and Drug Administration. The term itself encircles many different regulations…

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Smoke Study in Cleanroom Areas

The smoke study also known as dynamic air visualization study is the key qualification, maintenance and monitoring of facility to ensure the final product is free from contamination in a processing company. The smoke study in cleanroom area is conducted to visually confirm unidirectional airflow exiting High Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filters in a manufa…

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Different Types of Stainless Steel for Pharmaceuticals

There are different grades of stainless steel according to the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are not used in pharmaceutical. Pharmaceutical equipment is made of the material that should not react with the active material or excipients used in pharmaceutical manufacturing.

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Hold Time Study in Pharmaceutical Manufacturing

Sometimes during manufacturing, the in-process materials need to be held for a period more than usual. Hold time study during manufacturing is the validation of the hold time period of in-process materials. Now hold time study during pharmaceutical manufacturing has more importance because it is now recommended by the World Health Organization (WHO).

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Quality Management System (QMS)

Organizations engaged in the distribution, as well as the storage of materials along with products, should monitor, establish, maintain and implement the aspects of the quality management system that allows the delivery of resources, product and services, and materials with the requisite quality and safety.

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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.

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Re-validation of Purified Water System

Water is a critical ingredient widely used in the pharmaceutical industry for the processing, formulation, and production of pharmaceuticals. Due to an increase of micro-organisms in water during distribution, purification and storage; constant control of microbiological quality, inorganic and organic impurities in water are critical.

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Identification of Worst Case in Cleaning Validation

It is not possible to carry out cleaning validation of all products manufactured in the facility. Therefore, products are selected on the basis of the worst case. Worst case is the condition when it is difficult to clean the residues of the manufactured product from the equipment surface.

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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…

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A Brief Description of the Entire Audit Process in Pharmaceuticals

Auditing in the pharmaceutical industry is an important tool to improve the efficiency and quality of products. It ensures the implementation of good manufacturing practices and regulatory guidelines effectively. In this article, we will understand the whole auditing process in pharmaceuticals.

Why Auditing is Important in PharmaceuticalsThe efficiency of quality control measures and adherence to…

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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…

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Planning and Execution of Internal Audits in Pharmaceuticals

In any type of audit, the first and most important part is making a plan. In order to make the execution of audit of pharmaceutical effective and efficient, a good audit plan is compulsory. Internal Audits can be a valuable tool for any company for information collection and assessment of daily performance.

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Regulatory Guidelines on Data Integrity

The pharmaceutical industry has been on the public eye for a long time now. People all over the world depend on quality medicine, safe to use drugs and above all, those that are effective in curing the disease they are meant to cure.

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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…

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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.

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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.

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Components of GMP : GMP in Detail

GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products. There are several guidelines for good manufacturing practices worldwide but GMP guidelines provided by WHO and FDA are followed worldwide. These guidelines have recommendations for almost all departments of pharmaceutical firms like manufactu…

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Importance of Data Integrity in cGMP: Ensuring Drug Safety and Quality

In 2016 FDA published a guidance “Pharmaceutical Manufacturing/Quality Standards Data Integrity and Compliance with cGMP” to highlight the data integrity issues found during the FDA inspections in pharmaceutical companies. FDA emphasized data integrity and its importance to ensure the safety and quality of drugs to protect public health. Data integrity violations result in various regulatory acti…

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New FDA Update on Glycerin, Propylene Glycol, Maltitol Solution and other Glycols

FDA recently published a guidance for manufacturers and suppliers of the glycols to spread awareness about the potential health risk. In early 2023 FDA received the reports on poisoning of liquid drug products those have glycerin and glycols as ingredients. These products were contaminated with diethylene glycol or ethylene glycol. The aim of this guidance is to aware the manufacturers to prevent…

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Calculation for Capacity of Tablet Coating Machine

The quantity of tablets used for coating in coating pan plays a great role in getting good coating results. The capacity of the coating machine pan should be calculated to get a uniform coating. Inadequate quantity of tablets used for coating in the pan may cause different coating problems.

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Root Cause Analysis with Examples

Root Cause Analysis is the most important factor in determining the quality of each organization including the pharmaceutical industry, it is a methodology of knowing the first action that leads to the sequence which in turn leads to the problem and finds a way to solve this problem.

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Possible Causes of Out of Specification

Out of specification is the deviation of the product from the pre-determined specification. It means when a product is unable to meet the predefined limits for that particular product. There are various possibilities that may be responsible for these deviations.

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