What is VMP Brief information about Qualification, Validation and calibration of Equipment, Instrument and System. A document providing information on the company’s validation work programme. It should be define details of and timescales for the validation work to be performed. Responsibilities relating to the plan should be stated. 2.2 Which Guideline follow for preparation of VMP PIC/S (PI 006), WHO TRS 961, Eudralex Volume 4 2.3 Contents of VMP. Cover Page, Table of contents Approval of document Introduction, Objective, Scope Quality policy Validation policy Quality Risk Management Policy Responsibility Validation / Qualification Schematic Flow Validation and Qualification approach Revalidation and Requalification approach Qualification Activity Facility Qualification Qualification and Validation of Utilities Equipment Qualification Laboratory Instruments and Equipment Personnel Qualification Products and Process Validation E
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Requirement of Active and Passive Air Sampling in Controlled Areas
Air sampling is a mandatory procedure to be followed in pharmaceuticals to produce the contamination free quality product. What would you say if I ask for the causes the most contamination of products during the manufacture of pharmaceuticals? However, air is another keysource of contaminationthat most pharmaceutical facilitiesoften ignore to take precaution from. Air samplingor air monitoring is essential for Quality Control(QC) purposes especially in companies that manufacture pharmaceutical products in controlled areas or clean rooms with filtered air.Well, what pharmacists, health care practitioners, and microbiologists refer to as air sampling can simply be defined as taking a correct measurement of the practical airborne bacteria, mold, yeast, spores and fungal cells which can be collectively referred to as bioburden in the surrounding air. The two main methods used to sample air are: 1 .Active air sampling/ monitoring 2.Passive air sampling/ monitoring 1. Active Air Sampl
New Changes in ISO Classification of Air Cleanliness
Most awaited update to ISO 14644-1 is released and it has good changes those are useful for pharmaceutical manufacturing facilities. ISO 14644 Part 1 is a useful guide to maintain the good manufacturing practices in sterile pharmaceutical manufacturing as well as the oral dosage forms. This document provides the standards for the clean room classification. Revision of the guidance was started since 2007 and its drafts are already published in 2011, 2012,2014 and 2015 but none was finalized and 1999 version was applicable and expecting a new version. Finally a 2015 version is released and following are the major changes those are made in 1999 version of the ISO 14644-1 1. Title of the ISO 14644-1 is changed from “Classification of air cleanliness” to “Classification of air cleanliness by particle concentration”. 2. The number of sampling points in the area is no longer calculated as the square root of the surface area formula but it is now taken from the table giv
Activated Carbon Filter and Increase in Eficiency for Water treatment plant in pharma company..
Efficiency for Water System Activated carbon filters are used for water purification in water systems and application of these filters can increase the efficiency of water system. Dheeraj shukla totalpharmasoloution.blogspot.in . 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 Activated carbon filter contains carbon particles of various sizes ranging from 10 to 50 mesh. Activated carbon is prepared from coconut shells by burning in the absence of oxygen generally in an atmosphere containing nitrogen or another inert gas. This carbon is then activated by steam or chemical methods. In steam activation, this carbon is heated at 750- 950°C in the presence of steam. Steam activated carbon co
Chemical Sanitization of RO Systems
Sanitization of the reverse osmosis water purification system and biofilm removal from water system. 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. Typically this is done in a two-step process. The first step commonly involves the use of an acid cleaner such as citric acid to remove the inorganic foulants. Next, a high-pH cleaner such as sodium hydroxide is used in order to remove organic foulants. Then the system is sanitized with one ofthe following agents: formaldehyde, hydrogen peroxide, or peracetic acid/hydrogen peroxide. It is important to consult the manufacturer of the RO system to determine the correct concentrations of the chemicals that a
Reverse Osmosis System
Reverse osmosis is the best known filtration method and it is widely used in pharmaceutical water systems. This process is used to remove the particles including ions from the water. Reverse osmosis system contain a semi-permeable membrane that allows to pass the water and rejects the contaminants. In most of the reverse osmosis system it cleans the membrane it self and the process is known as crossflow. Reverse osmosis is capable to remove the salts, sugars, proteins, dyes, bacteria and other particles having the molecular weight greater than 250 daltons even viruses. The reverse osmosis process requires a force to pass the water through the membrane known as driving force. This force is applied in the form of pressure with the help of high pressure pumps. Contaminates of water are separated and collected in a tank known as concentrate. Generally the RO system recovers70-80% of feed water and this efficiency decreaseas the membrane is used.The membranes are
Problems Associated with Pharmaceutical Cleanroom Areas
Maintenance of cleanroom is a critical task and have different problems of microbial contamination. Most of the contamination occurs due to the personnel working in area. Pharmaceutical cleanroom areas are used to protect pharmaceutical products from pollutants that cause undesired contamination in pharmaceutical products to be produced. These contaminants can occur due to a number of reasons. Human being plays a significant role in producing this contamination through vital body organs such as the skin Fluids that are used to decontaminate the clean rooms can cause problems. These fluids include water, detergents, and sanitizers that do not meet the required standards. Dust contains a lot of particulate particles that produce varied effects in pharmaceutical clean room areas. Dust particles are like to have spores and bacteria that are viable . Human Beings have microflora that lives on skin surfaces and underneath. The skin plays host to almost a trillion microorganisms. Th