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
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 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
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.
- Routine Inspection: Quality System Inspection
- Pre-approval Inspection for Pre-market Approval (PMA): Country specific inspections
- 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.
- For-cause Inspection (Investigational): Inspectors have specific directions for the inspection that are not publicly available.
Aug 7, 2014
In order to achieve its effect, a drug must first be administered in a suitable dosage form at an appropriate site. It must be absorbed effectively from the site of administration and distributed in the body to reach its site of action. After its action, for the termination of its effect, the drug must be metabolized, and metabolites must be excreted from the body.
Aug 3, 2014
Fluidized bed dryer (FBD) is well known and widely used equipment in pharmaceutical manufacturing. It is used in granulation process for drying the material to get desired moisture content in the tablet formulation granules.
Jul 28, 2014
Revalidation of any process is an essential part of the validation. It improves the quality of the product and increases the smoothness of the process.
Jul 20, 2014
Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process.
Jul 13, 2014
A protocol is a written statement to conduct the validation process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval.
Jul 11, 2014
Routes of administration of a drug is determined by its physical and chemical properties, patient characteristics and the rapidity of response desired. Major routes are oral, parenteral and topical.
Jul 7, 2014
A drug is defined as a substance used for diagnosis, prevention and treatment of disease. A dosage form of a drug is a product suited for administration to the patient by various routes for diagnosis or treatment of disease. Suitable dosage forms are needed for protection of the drug from destructive influences of the atmospheric oxygen or moisture, for protection of drug from destruction from gastric acid on oral administration, to mask bitter taste and foul odour, to provide extended drug action through controlled release mechanism etc. Following agents are used with drug for suitable dosage form.
Jul 1, 2014
Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Jun 29, 2014
Jun 23, 2014
Blend uniformity is an important factor in pharmaceutical manufacturing. A poor uniformity of the blend can cause the rejection of the product that can lead to the loss of revenue.
Jun 15, 2014
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.
Jun 8, 2014
The purpose of an audit trail is to make the electronic data secure and traceable. Audit trail is a regulatory requirement in pharmaceutical manufacturing. Audit trail shows in record the name of persons who assessed the computer system with the date and time. It also helps to recover the lost data.
May 26, 2014
Depyrogenation is the removal of pyrogen (endotoxins) from the pharmaceutical materials or equipments. Endotoxins are the lipopolysaccharides found in the cell walls of the gram negative bacteria. Pyrogen causes fever when enter in bloodstream.
May 18, 2014
Buying medicines online through internet can save your time and sometimes money. But you should be careful when ordering the prescription medicines online.
May 14, 2014
May 5, 2014
Validation is a documented evidence of the consistency of any process or system. It was firstly appeared in 1978 in United States by the Food and Drug Administration (FDA) to investigate the failure of the product in sterility and now it is very common concept in the pharmaceutical industries throughout the world.
Apr 28, 2014
Apr 18, 2014
Quality of pharmaceutical products majorly depends upon the sampling of the excipents 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.