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Pharmaceutical Guidelines




Jan 31, 2016

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 of mobile phase composition.
Jan 27, 2016

Working and Principle of Tablet Coating Machine


A tablet coating machine is an equipment that coats the external surface of a tablet using a thin film of coating material. Working principle of tablet coating machine is relatively simple where application of coating material is done on a moving bed of tablets and removing rapidly the solvent using a current of hot air.
Jan 24, 2016

Different Types of HPLC Columns Used in Analysis


Columns are the main component in HPLC because column is responsible for the separation of the sample components. Sample passes through the column with the mobile phase and separates in its components when it comes out from the column.
Jan 21, 2016

Isolators and Their Use in Sterile Manufacturing


An isolator can best be defined as an arrangement of physical barricades which are incorporated to a degree that the isolator is capable of being sealed; so as that it can undertake a scheduled leak tests that are based on pressure, to attain stated limits.
Jan 19, 2016

Working and Principle of Colloidal Mill


Pharmaceutical companies work with small compound particles. They seek to separate chemical compounds to get to the smallest state of the compounds. That is why the colloidal mill is important in the pharmaceutical manufacturing industries. This is a machine that is used to reduce the size of particles of solids that are suspended in a liquid. When a liquid is suspended in another liquid, meaning that they are immiscible, this machine is used alternatively to reduce the size of this droplet.
Jan 17, 2016

Determination of Shelf Life of Solutions in Laboratory


Incorrect strength or concentration of volumetric solutions, reagents and buffer solutions can alter the results of analyzed products. Solutions prepared for chemical analysis are not stable for a longer period.
Jan 10, 2016

Working and Principle of Rapid Mixer Granulator (RMG)


Rapid mixer granulator is widely used equipment in pharmaceutical manufacturing. It is used to mix the pharmaceutical ingredients and make the granules before compression. Impellers and chopper are mainly responsible for wet granulation in the rapid mixer granulator.
Jan 3, 2016

Regulatory Requirements for Market Complaints


The process of manufacturing is characterized by a number of steps, checks, tests, audits as well as evaluations along with other elements of quality like validations and many others. All these components give confidence to the process or system that it is functioning as expected. While all these elements are critical, the final hurdle is to make sure that the product is successfully manufactured with expected quality.
Dec 30, 2015

Types of Airlocks and Requirement in Controlled Areas


Airlock helps to protect the classified area from the contamination that may occur during the entry and exit of personnel and material.
Dec 28, 2015

Common Ways to Avoid the Most Frequent GMP Errors


Most of the 483s and warning letters are issued because of the 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.
Dec 20, 2015

What does Inspector Look for during FDA Inspection?


FDA inspections in pharmaceutical manufacturing units is being critical these days and it seems that it will be more critical in future because FDA is focusing more on product quality as well as its documentation.
Dec 13, 2015

FDA’s Top Data Integrity Issues Found During Inspections


Data integrity is the common issue that is found during the FDA inspections. When FDA finds any invalid or unreliable data during inspection, it is considered by FDA that the quality of the products manufactured in such a manufacturing facility cannot be good. FDA issues warning letter when the violation of 21 CFR part 11 is found during inspection.
Dec 6, 2015

Top 5 Tips for a FDA Inspection


It is being difficult to handle a FDA audit these days because a lot of warning letters are being issued to different pharmaceutical companies. Following are some tips to handle the FDA inspection properly.
Nov 29, 2015

Chlorination and De-chlorination of Water System


Purified water is a basic requirement of any pharmaceutical industry. Generally the source of raw water remains a bore well and raw water is stored in a storage tank. This raw water is stored for several days. These storage tanks are not cleaned for many days. Due to these situation problem of microbial growth would occur in raw water storage tank and con contaminate the whole water system.
Nov 22, 2015

Buffer Area and Its Maintenance in Sterile Facility


Buffer area is the sterile zones in pharmaceutical manufacturing. Generally compounding area in sterile pharmaceutical preparation facility is known as buffer area. Buffer area is always ISO 7 area (class 10,000) or better air quality.
Nov 15, 2015

Sterile Area (Cleanroom) Qualification


Sterile area qualification and HVAC system qualification are two different things but most of the tests are same because HVAC system is qualified by its performance as quality of the area. Qualification document of the HVAC system and the sterile area should be prepared separately.
Sterile area can be qualified by applying following tests.
Nov 8, 2015

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.
Nov 1, 2015

Ultra Violet Light Disinfection in Pharmaceuticals


Ultra violet light is used as a disinfection agent in pharmaceuticals. Short wavelengths of ultraviolet light create harmful effect on microorganisms by destroying their nucleic acids and prevent the growth of the microbial cells.
Oct 25, 2015

Computer System Validation in Pharmaceuticals


Validation is a critical tool to assure the quality of computer system performance. Computer system software validation increases the reliability of systems, resulting in fewer errors and less risk to process and data integrity. Computer system validation also reduces long term system and project costs by minimizing the cost of maintenance and rework.
Oct 18, 2015

Steps for HPLC Method Development


Analytical method development is considered as a critical process in pharmaceuticals. Availability of the different types of columns, operating parameters, mobile phase composition, diluent and pH values make it critical to develop an analytical method. A good analytical method should be simple, used column, mobile phase and buffer should be common. It can be done easily step by step.