Apr 12, 2015
Resistance in microbes against the disinfectants used for cleaning is a serious issue in pharmaceuticals but in most of the pharmaceutical manufacturing units it is ignored. Continuous use of same disinfectants may lead to the development of resistance in the microbes.
Apr 6, 2015
Mar 29, 2015
Mar 23, 2015
Membrane filters are thin polymer films those have many microscopic pores. These filters have different pores sizes and used for different purposes accordingly. Membrane filters are used in various pharmaceutical activities. Cellulose filters are most commonly used filters in microbial analysis and reverse osmosis water systems. Most of the cellulose filters are hydrophobic in nature.
Mar 15, 2015
Pharmaceutical preparations have many ingredients those promote the microbial growth. Due to this, these non-sterile products are susceptible to the microbial growth. To prevent this microbial growth, it is required to add some antimicrobial compounds known as preservatives. These preservative does not have any harmful effect on patients consuming the products.
Mar 8, 2015
Binder is a chemical substance with adhesive property. They bind the excipients and drug together to provide them mechanical strength. They help to form intergranular bonds. The binder may fuse together locally and form binder bridges between granule surfaces which cohere the granules to each other. Such bridges may be the result of a softening or melting of binder layers during compression phase.
Feb 23, 2015
Lubricants are agents added in small quantities to tablet and capsule formulations to reduce the friction and improve certain processing characteristics.
Feb 15, 2015
A lot of pharmaceutical products are light sensitive those degrade when directly exposed to the light. Some impurities may develop during this degradation and product may fail during the quality control analysis. These impurities may harm the patient’s health.
Feb 8, 2015
There are different grades of stainless steels according the composition like 302, 304, 304L, 316, 316L, 410, 430, 440 etc. but all are not used in pharmaceutical. Pharmaceutical equipment are made with the material that should not react with the active material or excipients used in pharmaceutical manufacturing.
Feb 1, 2015
Maintenance of original raw data is a prime responsibility of all pharmaceutical manufacturing units. Data integrity is to maintain the data securely so that only authorized person can edit or delete and change log must be created for all users. FDA issued seven warning letters related to data integrity in 2014.
Jan 25, 2015
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
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
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 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
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
Dec 15, 2014
Dec 8, 2014
Dec 1, 2014
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
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
Nov 6, 2014
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
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
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.