Pharmaceutical Top Articles

Know the regulatory guidance on market complaints of pharmaceutical products. 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.

Airlocks are closed rooms having two or more doors between two different controlled areas having different cleanliness levels as class B and class C, class C and class D areas. These airlocks prevent the direct air flow between these areas during the entry of material or personnel.

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.

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. Document fabrication particularly in Indian pharmaceutical companies is a common issue.

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. Following are the common data integrity issues observed by FDA during their inspections: 1.

Learn the tips to handle the FDA inspection successfully in pharmaceutical manufacturing unit. 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 audits properly. 1.

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.

UV 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. First of all ultraviolet light is used for water disinfection is United States in 1916.

An easy to understand overview of computer system validation with HPLC system including the software validation. 1. User Requirement Specification: URS for HPLC system is prepared to describe the critical functionalities those are required for our analysis. Following point should be considered during preparation of user requirement specification for a HPLC system.

Know about the different stages of the HPLC analytical method development in pharmaceutical analysis. 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.

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 water is also removed. It plays an important role in water purification systems where chlorine is added for decontamination.

In the past, it was not important to validate the transportation of the pharmaceutical products but now it is recommended by all major regulatory agencies. Storage conditions during transit of the pharmaceutical products should be validated because it may affect the product stability.

Petri dishes were first used by German physician Julius Petri in 1887. He covered one culture plate to another plate to prevent the contamination. Before him the culture plates were covered with the glass bell jars. All of we know that the Petriplates are incubated in inverted position but this question arises in our mind that why these plates are incubated in inverted position?

Sieves and screens are widely used in the pharmaceutical manufacturing as well as in the quality control to determine the particle size of the raw materials. Mesh is the most common measurement unit used for the sieves and screens. Generally 40 to 400 mesh sieves are used in pharmaceutical manufacturing during shifting and milling of raw material.

Maintenance of clean area has its importance in sterile manufacturing. Sterility of the sterile products is the most important factor for the product quality and it can be achieved only by the proper maintenance of the manufacturing area. Areas surrounding the core manufacturing area are known as supporting areas.

Ultra violet radiation plays a vital role in pharmaceutical industry to control the microbial contamination in various stages including water system. No chemical is required to add in water; hence the procedure is environment friendly and safe. A high dose of UV radiation is required to control the microbes and the process can be reverse in the presence of light.

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.

A pH meter is used to determine the acidity or alkalinity of the solution. pH is the concentration of hydrogen ions in the solution. A solution containing more H ions remains acidic while the solution containing more OH ions remains alkaline. pH value of solutions ranges from 1 to 14.

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.

Different storage conditions are required in pharmaceuticals. In storage area drug substances are stored on different conditions according to their requirements. Some chemicals and solutions in quality control and media in microbiology section are required to store in specific conditions. 1. Room Temperature: Most of the pharmaceutical activities are done at room temperature.

Temperature sensors are used in different processes in pharmaceuticals. Different types of temperatures are used in different processes according to their accuracy needs. There are following three common types of temperature sensors. 1. Thermocouple: These are most commonly used sensors for temperature measurement. These have high accuracy and less expensive than others.

Any process that can have any type of risk should go through the quality risk management. These risks may impact the quality of the pharmaceutical products. It is a requirement of good manufacturing practices. Quality risk management is an effective tool to maintain and improve the quality of the pharmaceutical products.

It is necessary to use recovery factor for accurate results in cleaning validation of pharmaceutical manufacturing equipments. Recovery factor is the recovery of swabbed material from the equipment to the solution.

Know the importance of the blending time and effects of extended mixing time on pharmaceutical product quality. In pharmaceutical manufacturing more than one ingredients are mixed during blending. It always remains in one's mind that what will happened if we increase the mixing time than specified in the batch manufacturing records.

Technology transfer is the process by which the manufacturing process and analytical method is transferred from one manufacturing unit to another unit or from R&D to manufacturing unit. Technology transfer from R&D to manufacturing site is critical because of the scale up of the product from pilot batch to large scale commercial batch.