Validation Program in Pharmaceutical Industries

Validation is defined as:
Establishing documented evidence that provides a high degree of assurance that a process, system, equipment or assay will consistently produce the desired results according to predetermined specifications and quality attributes. Qualification is defined as:
The documented action of showing that any equipment works correctly and consistently leads to the expected results.

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Tips to Develop Equipment Cleaning Procedure

A well-developed cleaning method is a primary requirement for the cleaning validation. Cleaning procedure should be developed before starting the cleaning validation. Following things should be considered during development of good cleaning procedure.

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Basics of Cleaning Validation

Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufactured are not contaminated. The removal of the residues of the previous products from manufacturing equipment is known as cleaning. If the whole process of cleaning has been documented, it is referred to as cleaning method validation.

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Validation of Utility Systems in Pharmaceutical Facilities

This chapter provides a summary of the key validation test functions and acceptance criteria for each utility system. These are provided as a guideline for those involved in the validation of ABC Pharmaceutical. Approval of this Master Plan neither provides approval of these test functions and acceptance criteria nor does it limit the test functions and acceptance criteria included in any protoco…

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Low Temperature Sterilization Process (115°C) and Its Validation

Sterilization of the media and material is generally done at 121 °C but sometimes it is required to do at low temperature (115 °C) because of heat sensitivity of the material. This sterilization below 121 °C is called Low-Temperature Sterilization.

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Basic Requirements for Process Validation Exercise

Every pharmaceutical plant has got a prime objective of manufacturing products of required attributes and quality in a consistent manner, at the lowest possible cost. In order to maintain the quality of a drug product and to ensure its safety, manufacturing process validation has to be done. It is the essential element in ensuring that a drug product is pure, efficient, save and that its quality …

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Requirements and Maintenance of HVAC System in Manufacturing Facilities

Installation of a working and well-maintained heating, ventilation, and air conditioning system (HVAC) is a fundamental requirement in any pharmaceutical facility that value quality, and conducive working environment. Many pharmaceutical and biopharmaceutical products fail due to the improper environmental conditions in the manufacturing area. Therefore, environmental conditions of the manufactur…

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Epoxy Flooring and Its Benefits in Pharmaceuticals

The floor coatings of companies manufacturing medicinal drugs should manage to resist most oils, acids, and solvents. Also, the coating must be resistant to abrasion and impact since the plant’s floors could easily be exposed to heavy traffic from hefty tools and machinery. A type of floor coating that can surely offer durable and hard wearing solutions is the epoxy flooring. This type of floor …

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Equipment Lubricants Used in Pharmaceuticals

Lubricants are used to minimize the faction between the moving surfaces of the machines. The fraction may cause the heating of the moving parts. It also helps to minimize the load on the machine and rust. Generally, lubricants are prepared with organic and synthetic compound those are not permitted in pharmaceuticals.

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ALCOA in Pharmaceuticals : A necessary tool for Quality

Any pharmaceutical product has to undergo a process before it can be used by the public. This process ensures that the product is safe for everyone. And if there are any side-effects of the product, the consumer can be warned about them beforehand. This helps to decide for whom the product would be suitable.

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How to Care for pH Meter Electrodes

pH meter electrodes measure the degree of acidity by comparing the aqueous solutions. The electrodes are immersed in with the reference half-cells built inside the electrodes. These half-cells are coated with silver chloride or AgCl.

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Gap Analysis for Regulatory Compliance

If you are preparing for any regulatory inspection then gap analysis can help in compliance with regulatory guidelines. A comparison between the regulatory guidance and current practices is known as gap analysis.

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Sanitation of Cleanroom Area in Pharmaceutical Manufacturing

It is important to maintain and clean the sterile pharmaceutical manufacturing clean room area periodically. The area should be clean after a defined period as per standard operating procedure.

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Activated Carbon Filter and Increase in Efficiency for Water System

The activated carbon filter is used to remove chlorine and organic matter from the water. It also removes the color and odor from the water hence the turbidity of the water is also removed. It plays an important role in water purification systems where chlorine is added for decontamination. ACF is unable to remove the microbes and hardness.

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Biofilm Removal and Chemical Sanitization of RO Systems

To control microbial growth, RO systems must be chemically sanitized on a regular basis. Prior to sanitation, it is important to chemically clean the first-pass RO system. This will help to disrupt any biofilm that protects viable bacteria from contact with the sanitant. It also removes foulants that will react with and chemically deplete the sanitizing agent.

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Planning and Procedure followed During Regulatory Audits

Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.

1 Routine Inspection: Quality System Inspection
2. Pre-approval Inspection for Pre-market Approval (PMA): Country-specific inspections
3. Follow-up on a warning letter (Violation): Inspector will look for evidence of the company's comp…

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Various Types of Blenders and Their Purpose

A blender is a very important equipment in the pharmaceutical industry, as a medicine is manufactured by mixing a number of drugs and chemicals. This mixing is required to be undertaken in either dry or wet state depending upon the chemical composition and the reactions allowed. There are various types of blenders available in the industry, each one having its own purpose. Some of them are discus…

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Duct Designing in HVAC System

Designing an air conditioning duct system is crucial while installing HVAC system in the enclosure. An improper design of HVAC system may not give that satisfaction of the comfort level as well as it may lead to a negative impact on your energy bill.

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Lean Six Sigma Concept

Lean Six Sigma (LSS) is a combination of two processes that were initially applied separately to improve business efficiency and effectiveness. In a nutshell, the lean methodology is aimed at reducing or totally eliminating steps that do not add value in a manufacturing process and six sigma is a data-driven methodology aimed at producing a continuous process with low defects.

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Difference Between HEPA and ULPA Filters

The two main types of air filters employed in biosafety cabinets, pharmaceutical manufacturing, electronic goods manufacturing, room air purification, and vacuum cleaner filters are High-Efficiency Particulate Air (HEPA) filters and Ultra-Low Particulate Air (ULPA) filters. Both these filters are designed to catch and remove tiny, airborne particulate matter such as bacteria, pollutants, and dust…

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ALCOA Principles of Data Integrity

Data integrity is highly important in any industry, but especially so in the pharmaceutical industry where any data error could mean serious consequences. Data integrity is defined as maintenance and assurance of data consistency and accuracy throughout its life-cycle. Keeping data consistent (unchanged from the very start to the end) is also a matter of data security and even though data integri…

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Quality Inspection in Pharmaceuticals

In pharmaceuticals, quality inspection involves a complete assessment and testing of medicinal products to ensure that they meet the required standards. It involves a number of actions taken place as discussed here.

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30 Common Ways to Avoid the Most Frequent GMP Errors

Most of the 483s and warning letters are issued because of common GMP errors. Below I have described common mistakes (and ways to avoid them) that I have seen and that many managers, supervisors, and executives have told me they have seen. Many common good manufacturing practice errors in pharmaceuticals can be easily avoided by following a few simple rules.

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Reynolds Number and Its Significance in Purified Water System

Purified water is commonly used in the pharmaceutical industry, science laboratories, laser cutting and automotive use. Purified water finds a considerable amount of usage in the pharmaceutical industry in the form of raw material, component and solvent in the production of a number of medications.

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Types of Purified Water Systems in Pharmaceuticals

One of the most pronounced ingredients in any pharmaceutical engineering is water. Water serves as a solvent and ingredient for formulation in many pharmaceutical procedures. Special care and attention must, therefore, be taken to ensure that the water used, meets the standard quality for purified water. Water is purified to remove impurities and prevent microbes which might cause contamination o…

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How to Write a Factory Acceptance Test FAT Protocol

Factory Acceptance Test (FAT) is done at the equipment manufacturing site of the vendor before the shipping. A proper FAT can help to minimize the problems occur during the installation of the equipment at the site. A FAT protocol can be written as follows.

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Restricted Access Barrier System (RABS) in Pharmaceuticals

The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the int…

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Sanitization of RO Membranes in Purified Water System

The main ingredient in most of the pharmaceutical products used by people is water. Given the ever-increasing concerns about the ingredients used to make pharmaceutical products, it is important to ensure that the water used is stable and consistent.

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Checks Before and After Installation of HVAC System

HVAC system provides a safe and controlled environment for pharmaceutical manufacturing because most of the pharmaceutical drugs are temperature and humidity sensitive. It also helps to maintain the classified area by controlling the dust particles and microbial load.

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Importance of Microbiological Analysis in Cleaning Method Validation

Cleaning Method validation is the process in which documentation of how the cleaning process of manufacturing equipment is done. Most times during manufacturing and processing of pharmaceutical products, active residues are left on the equipment and it may cause contamination of the next product to be processed in the same equipment.

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