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Jan 25, 2015

How to Write a Factory Acceptance Test (FAT) Protocol?


Factory Acceptance Test (FAT) is done at the equipment manufacturing site of 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.
Jan 18, 2015

Removal of the Pathogenic Bacteria from Water Systems


Pathogens are the microorganisms which are capable the cause disease. All of these microorganisms are harmful for human. Those can survive into the purified water as well as the water for injection. The pathogenic bacteria found in water system are E.coli, Salmonella and Pseudomanas. Generally these are attached in the filtration membranes of water system such as Reverse Osmosis membranes and Ultra-filtration membranes or sometimes a biofilm can be formed in pipelines of water system.
Jan 11, 2015

Preparation of User Requirement Specification (URS) of Equipments


User Requirement Specification (URS) is a list of all requirements of buyer regarding the equipment to be purchased. URS is prepared by the equipment user department. It is sent to equipment manufacturer to make it as desired criteria. Following points should be included in a pharmaceutical URS.
Jan 4, 2015

NOEL and MACO Calculations in Cleaning Validation


NOEL is “No Observed Effect Level” of any pharmaceutical drug. It is determined to calculate the MACO (Maximum Allowable Carry Over) in cleaning validation. NOEL is the amount of drug in mg that does not have any effect on the human health.
Dec 28, 2014

It is Better to Handle the Microbial Cultures in Separate Room


Separate laminar air flow unit in separate room for handling of microbial cultures is a new trend in pharmaceuticals now-a-days. Before some time all microbiological activities were done under same laminar airflow bench including positive cultures, sub-culturing, sample preparation and analysis. But now it is changing to have separate area for culture handling and sample analysis.
Dec 22, 2014

Procedure for Investigation of Media Fill Test Failure


Media fill test assures the sterility of the sterile manufacturing process. When any media fill test fails, it shows the contamination in the manufacturing system. This failure must be investigated.
Dec 15, 2014

How is It Important to Identify the Environmental Isolates?


There are a lot of microorganisms found the air. Mostly microorganisms found in air are bacteria. These are determined by the air sampling methods. Growth of these microbes on nutrient media helps to identify them.

Dec 8, 2014

How to Remove Residual Chlorine before Microbial Analysis?


Raw water is chlorinated by adding sodium hypochlorite (NaOCl) to make its concentration 2-4 ppm. Chlorination of water is done to remove the microbial load from the water. It helps the water system to produce the purified water of specified microbial quality.
Dec 1, 2014

Lubricants Used in Pharmaceutical Manufacturing Equipments


Lubricants are used to minimize the faction between the moving surfaces of the machines. 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.
Nov 23, 2014

Drift and Its Importance in Analytical Balances


In the pharmaceutical industry and bioscience research field, many laboratories make use of analytical balances. The analytical balances used in the bioscience research and pharmaceutical industry are very sensitive. These balances can be heavily affected by the way the measuring personnel handle them and by the environment in which they are installed. The environment in the pharmaceutical laboratory needs to be assessed by running assessment tests. Based on the results of these assessments should be proposed concrete measures for improving the lab environment.
Nov 9, 2014

3-Sigma Formula for Trend Analysis Limits


All observations related to the water system and environmental monitoring are subject to trend analysis. Trends are prepared but its limit always remains a point of discussion because all regulatory guidelines provide single limit for the tests. No alert and action limit is given.
Nov 6, 2014

FDA Forms Generally Used in Pharmaceutical Inspection


There are different forms those are issued by the FDA at the different stages of the regulatory audits. Different issues are communicated through these forms between FDA and the manufacturing facility. Some of them are:
1. Form 482 - Notice of Inspection
2. Form 483 - Observations of Inspection
3. Form 484 - Receipt of Samples
4. Form 463 - Affidavit
Nov 2, 2014

FDA's Form 483 and Warning Letters


A lot of pharmaceutical professionals have confusion between Form 483 and Warning Letters. Both of these are issued by Food and Drug Administration (FDA) after a regulatory inspection of manufacturing facility and both are the way of communication.
Oct 26, 2014

Importance of Validation of Effective Working of UV Light in Purified Water System


Validation of effective working of UV light in purified water system aims to demonstrate that the UV light purification process when operated within set limits produces highly purified pharmaceutical water with a high degree of assertion. Validation of this method is necessary to get pharmaceutical water with all necessary quality attributes. Validation also offers a framework to initiate full control over the procedure, which monitors efficiency, safety and ultimately the method outcomes.
Oct 6, 2014

Importance of Cation Exchanger in Purified Water System


Water is widely used and an important raw material in the processing, formulation and production of pharmaceutical products and medical devices. Purified water has unique chemical properties making it ideal to absorb, dissolve or adsorb many different compounds. Having a purified water system in pharmaceuticals is a great way to control the quality of water all through the production, storage and distribution processes.
Sep 28, 2014

Mixed Bed Ion Exchanger in Purified Water System


Water is a key element for the pharmaceutical and healthcare industries. Pharmaceutical manufacturers are concerned with producing purified water that meets defined standard quality to minimize any risk to patients' health or interfere with the manufacturing process. Water acts as an important ingredient in many formulations and also as a cleaning agent. This makes the production of highly purified water and pyrogen free for injection to very critical and should meet the international standards. The most commonly and accepted method of purification is the use of mixed bed ion exchanger in the purified water systems for pharmaceuticals.

Sep 21, 2014

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. The Reverse Osmosis (RO) system is at the heart of the process of water purification. It uses semi-permeable polyamide membranes that provide rejections of organic and ionic impurities that exceed 99%. The RO membranes pores are in real sense intersegmental spaces within the polymer molecules. The membranes are large enough to allow permeation of water molecules but not big enough to allow hydrated chemical ions to pass through. Below is a look at how sanitization of membranes in purified water system is done. 
Sep 14, 2014

Calculation for Determination of Weighing Range of Balances


Balances are used to weigh different things as raw material, dispensed material and samples. Sometimes very low quantity is weighed for analysis. An error in the weighed material can cause a big variation in analytical results.
Sep 12, 2014

Understanding the Process of Finding Impurities in Pharmaceutical Analysis


The primary goal of any synthetic process is to create completely pure products, though in reality marginal amount of impurity always has been found to be present in the final product after the complete chemical synthesis and manufacturing process. The presence of the impurities can enhance the level of toxicity and that is why an impurity analysis process has been carried out. Understanding the nature of these impurities is important. The goal of the analysis is to check whether these impurities may bring possible hazards or not. There are some known and unknown impurities in pharmaceutical analysis. The intention of pharmaceutical analysis should be to omit these impurities completely; if not then their intensity should be taken down to a controllable level so that no possible hazards can take place.
Sep 7, 2014

Significant Change in Pharmaceutical Stability Testing


Stability of the pharmaceutical products is determined by storing the product under Accelerated and Long Term Conditions. The product is then analyzed at different time stations for any significant change in physical or chemical condition.
Sep 1, 2014

Shelf Life Estimation of Pharmaceutical Products


All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts may harmful for health of the patients consuming the drug. Shelf life of the pharmaceutical products is the time period for which the product maintains its identity and quality when stored at the conditions defined on the label of the product.
Aug 24, 2014

Sampling and Testing in Exhibit and Process Validation Batches


Sample is a portion of a material collected according to a defined sampling procedure. The size of any sample should be sufficient to allow all anticipated test procedures to be carried out, including all repetitions and retention samples.
Aug 20, 2014

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.
Aug 13, 2014

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 compliance with a plan of action made in the response to the warning letter.
  4. For-cause Inspection (Investigational): Inspectors have specific directions for the inspection that are not publicly available.