Separate laminar air flow unit in a separate room for the handling of microbial cultures is a new trend in pharmaceuticals nowadays. 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 a separate area for culture handling and sample analysis.
Identification of 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. The growth of these microbes in nutrient media helps to identify them.
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.
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 a single limit for the tests. No alert and action limit is given.
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 an…
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.
Calculation for 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.
Process of Finding Impurities in Pharmaceutical Products
The primary goal of any synthetic process is to create completely pure products, though in reality the 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.
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.
SOP for Product Registration
1.0 OBJECTIVE
To lay down a procedure for product registration.
2.0 SCOPE This procedure is applicable to the registration of the products in the manufacturing facility.
3.0 RESPONSIBILITY Executive Quality Assurance Manager Regulatory Affairs
4.0 ACCOUNTABILITY Technical Head 5.0 PROCEDURE 5.1 Marketing team will take initiative to the requirement of the registration of new product (exiting pr…
2.0 SCOPE This procedure is applicable to the registration of the products in the manufacturing facility.
3.0 RESPONSIBILITY Executive Quality Assurance Manager Regulatory Affairs
4.0 ACCOUNTABILITY Technical Head 5.0 PROCEDURE 5.1 Marketing team will take initiative to the requirement of the registration of new product (exiting pr…
SOP for Entry in Quality Assurance Department
1.0 OBJECTIVE
To define the lay down the procedure for all persons entering in the quality assurance department.
2.0 SCOPE This procedure applies to the quality assurance department of the manufacturing facility.
3.0 RESPONIBILITY Executive/ Manager Quality Assurance
4.0 ACCOUNTABILITY Manager - Quality Assurance
5.0 PROCEDURE 5.1 Staff and workmen coming from other production block shall wear …
2.0 SCOPE This procedure applies to the quality assurance department of the manufacturing facility.
3.0 RESPONIBILITY Executive/ Manager Quality Assurance
4.0 ACCOUNTABILITY Manager - Quality Assurance
5.0 PROCEDURE 5.1 Staff and workmen coming from other production block shall wear …
Shelf Life Estimation of Pharmaceutical Products
All pharmaceutical drugs degrade with the time forming the byproducts. These byproducts may harmful to the health of the patients consuming the drug. The 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.
Optical Activity in Pharmaceutical Analysis
Chiral molecules are able to rotate the plane polarized light and this quality of these molecules is known as optical activity. Optical activity is measured by polarimeter. Polarimeter has a light source, polarizing filter, sampling tube and analyzing lens. Molecules having optical activity are known as optically active molecules.
Layout for Injection Manufacturing Unit
Area maintenance in sterile manufacturing is a difficult task because most of the areas in sterile manufacturing are of a higher grade than oral manufacturing.
Tablet Dissolution Test in Different Stages (S1, S2 and S3)
Dissolution test is done to verify the release of drug in the solution from the tablet because of binders, granulation, mixing and the coating may affect the release of drug from tablets.
Sampling Plan SQRT n+1 (√n+1) for Pharmaceuticals
Quality of pharmaceutical products majorly depends upon the sampling of the excipients and the active pharmaceutical ingredients. Proper sampling can give us confidence in our analysis. In other words, we can say – sampling is a starting process but is has its importance.
Analytical Method Development Process for New Products
1.0Objective: The purpose of the study is to develop analytical method for determination of Assay / Related Substances of new product by HPLC or UV-Vis Spectrophotometer as applicable.
2.0Introduction and Overview:
This guideline provides detailed information about analytical development to be carried out on all the aspects of the method of analysis. All the instruments/ equipment used to carry out t…
2.0Introduction and Overview:
This guideline provides detailed information about analytical development to be carried out on all the aspects of the method of analysis. All the instruments/ equipment used to carry out t…
Design of a Sterile Facility in Pharmaceuticals
Efficiency and the maintenance of the sterile area directly depend upon the design of the sterile facility. Good design can save the area maintenance cost and quality of the area.
Microbial Analysis of Purified Water and Water of Injection
Water is used in various processes in pharmaceutical manufacturing. Microbial contamination in water may cause contamination in pharmaceutical products. It is necessary to analyze the Purified Water and Water for Injection (WFI) for microbial contamination.
Importance and Determination of F0 Value in Sterilization
Generally, sterilization is done at 121 °C and it is a standard temperature for sterilization. If we want to sterilize the material at the temperature other than 121 °C then we must change the time of sterilization.
Determination of Z-Value for Biological Indicators
Z value is the temperature required to increase the thermal destruction by one log. In simple words, we can say the temperature required to increase the death rate or D value of the organisms by 10 times.
