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Pharmaceutical Guidelines


Dec 4, 2016

Process Analytical Technology (PAT) in Pharmaceuticals


Process Analytical Technology is a system for designing, analyzing and controlling manufacturing processes through timely measurement during processing. With the goal of ensuring final product quality, it analyzes raw and in- process materials. The PAT is now being deployed in the pharmaceutical industry, where it is seen as a technology that can help companies to improve their conformity with manufacturing regulations. The emphasis in PAT is in the manufacturing process to increase the basic premise of the current drug quality system because quality can’t be tested into products, it should be built-in or should be by design.

Nov 27, 2016

Difference between Sterilization and Depyrogenation


To understand the difference between sterilization and depyrogenation, we have to discus both of them separately, in length to really know the line that separates them. Basically, sterilization is a method that can remove, kill and deactivate microorganisms on a surface like for example the stainless equipments, media etc. On the other hand, due to the high variability of their molecular weight, pyrogens are hard to sterilize. Depyrogenation refers to removing pyrogen from a solution or pharmaceutical vials. Endotoxins are bacterial byproducts that become pyrogenic (active) when released to the blood stream.
Nov 20, 2016

Determination of Hot and Cold Spot in Stability Chamber


Everything from pharmaceutical products to personal consumer products are tested in stability chambers to get an accurate reading of conditions to be stored in. This process is absolutely foremost to be considered for FDA approval, the FDA requires proper testing and evidence of tests performed to monitor how products react, taking temperature, humidity and various other conditions into account.
Nov 14, 2016

Quality by Design (QbD) in Pharmaceuticals


The term quality means the appropriateness for the intended use. In the field of pharmacy, quality refers to the state of being free from any contamination and ability to treat the disease intended for. The Quality of the pharmaceutical commodity can be assessed by in vivo or in vitro execution tests. Quality by plan guarantees in vitro item execution and In vitro item execution gives affirmation of in vivo item execution. "Henceforth Quality by outline identify with Product Performance".
Nov 6, 2016

Forced Degradation Study in Pharmaceutical Stability


Forced degradation is also known as stress testing and drug is degraded forcefully by applying artificial methods. It is a useful tool to predict the stability of any Active Pharmaceutical Ingredient (API) or formulation product. It helps to know about the impurities developed during the storage of drug products in various environmental conditions.
Oct 30, 2016

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 quality management system that allows the delivery of resources, product and services, and materials with the requisite quality and safety.

Oct 23, 2016

Mean Kinetic Temperature (MKT) in Stability Studies


Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies. It helps to calculate the degradation of stability sample.
Oct 16, 2016

Importance and Method of De-gassing in Purified Water System


In pharmaceutical industries bore-well is the principle source of the raw water. Raw water is purified by water purification systems to use in pharmaceutical manufacturing. Cation and anion beds are used to remove the hardness of raw water.
Oct 9, 2016

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 United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is very common concept in the pharmaceutical industries throughout the world.
Oct 2, 2016

Calibration Frequency of Instruments and Other Measuring Devices


Calibration of instruments and other measuring devices is done to verify its performance. It is comparison of the reading found from the instrument or measuring device and the known value or reference standard. The difference between the measured value and standard value helps to determine the instrument performance.
Sep 25, 2016

Temperature and Humidity Validation/Mapping in Storage Area


Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at higher temperature therefore it important to validate the storage area for temperature.

Sep 18, 2016

Handling Static Charge in Pharmaceutical Manufacturing


Static charge is the electric current developed by the rubbing of moving parts of equipments or contact and separation of material particles. It is generated in different pharmaceutical manufacturing equipments during processing. Sometimes it is generated by the continuous flow of the powder on the equipment surface.
Sep 11, 2016

Major Audit Findings about Equipment and Instruments


1. Deviations through the equipment and instruments are not documented and investigated such as any equipment is not cleaned as per the defined procedure; calibration procedure is not followed properly etc.
Sep 4, 2016

Importance of Qualified Persons in Pharmaceuticals


Qualified and trained employees are the keys to manufacture the good quality product. Every step of pharmaceutical manufacturing and analysis should be done by the competent person. All regulatory agencies have their guidelines for qualified persons and their training.
Aug 28, 2016

Importance of Blend Uniformity in Manufacturing Process


Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue.
Aug 21, 2016

Why Firms Must Avoid FDA 483 and Warning Letters?


FDA has the mandate of ensuring the safety of the public by assuring the safety of drugs and medical devices among others. To this end, FDA officials occasionally visit manufacturing establishments for the purpose of carrying out an inspection to find out whether or not the establishment is in compliance. After an inspection, FDA officials may issue FDA 483 and warning letters. Sometimes, the manufacturer may receive an FDA 483 form without a warning letter.