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Jul 20, 2014

How Effectively Execute a Validation Protocol?

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

How to Write a Validation Protocol?

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

Different Routes of Drug Administration

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

Different Types of Dosage Forms in Pharmaceuticals

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

Requirements for Good Documentation Practice (GDP)

Good documentation practice GDP is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of any document.
Jun 29, 2014

Human Generated Contamination in Cleanroom and its Control

Cleanroom contamination is a major problem in sterile manufacturing and it is difficult to maintain the cleanroom area. People working area are the major source of contamination.
Jun 23, 2014

Importance of Blend Uniformity in Manufacturing Process

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

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.

Jun 8, 2014

Audit Trail Requirements in Pharmaceuticals

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 in Injection Manufacturing

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

Taking Care When Buying the Prescription Medicines Online

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

Layout for Injection Manufacturing Unit

Area maintenance in sterile manufacturing is a difficult task because most of the areas in sterile manufacturing are of higher grade than the oral manufacturing.

May 5, 2014

Importance of Validation in Pharmaceuticals

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

Media Fill Test for Sterile API Manufacturing Process

Media fill test is done to verify the sterility of the sterile manufacturing process. Media fill validation for sterile API is different from the sterile formulation media fill.
Apr 23, 2014

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 binders, granulation, mixing and coating may affect the release of drug from tablets.
Apr 18, 2014

Sampling Plan SQRT n+1 (√n+1) for Pharmaceuticals

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.
Apr 13, 2014

Pass boxes in Classified Areas

Pass box is used to transfer the material from lower cleanliness area to higher cleanliness area or vice-versa in classified area and also known as hatch. Pass box works as a barrier between two cleanliness level areas.
Apr 6, 2014

Temperature and Humidity Validation/Mapping in Storage Area

Temperature and humidity are important factors in the stability of the pharmaceutical ingredients. Temperature sensitive materials can degrade at higher temperature therefore it important to validate the storage area for temperature.
Apr 3, 2014

Types and Requirement of Airlocks in Controlled Areas

Airlock helps to protect the classified area from the contamination that may occur during the entry and exit of personnel and material.
Mar 30, 2014

Cleaning Method Validation Protocol for Pharmaceutical Equipments

The purpose of the study is to validate analytical method for determination of traces of   API contents in Swab & Rinse samples and to establish documented evidence and provide the procedure for the same.
Mar 23, 2014

Analytical Method Development Process for New Products

1.0  Objective:
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.
Mar 19, 2014

Why Dissolution Test Apparatus Calibration with Salicylic Acid Tablets was Stopped?

Prednisone and Salicylic acid tablets USP were used for the calibration of dissolution test apparatus. Prednisone tablets were disintegration type and Salicylic acid tablets were non-disintegration type.
Mar 10, 2014

How to Know the Generic Equivalents for Branded Medicines?

Branded medicines are very costly due to the additional cost for the brand promotion. There are a lot of generic alternatives for these costly branded medicines. This can help to save money for the same medicines.
Mar 2, 2014

Why Companies are Selling Same Drug in Different Prices?

There is a big difference in the prices of the pharmaceutical products in India. The products having same drugs with same label claim are being sold in different prices. Sometimes this difference increases the prices twice, thrice or even ten folds.