Pharmaguideline

The term ALCOA is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALC...

Introduction to Pharmaceutical Dosage Form Drugs are rarely delivered as pure chemical entities but are approximately usually provided as pr...

Stability study is an important part of pharmaceutical product quality. For safety, efficacy and quality of pharmaceutical products, environ...

In pharmaceutical industry materials are supplied from different suppliers. Supplier audits are a critical part to ensure the quality and sa...

In sterile product manufacturing where microbial contamination directly impacts product quality and patient safety environmental monitoring ...

In the pharmaceutical industry, the product quality is directly dependent on aseptic conditions maintained in manufacturing area. Media fill...

In pharmaceutical quality control, analytical method validation (AMV) is one of the most critical aspects that helps to ensure that methods ...

Water used as a raw material in pharmaceutical manufacturing industry. There are different grades of water used in pharmaceuticals but Water...

Process validation is an essential part of good manufacturing practices (GMP) . It is, therefore, an element of the quality assurance progra...

In pharmaceutical industry analytical methods are the heart of quantity control analysis from analysis of raw materials to confirm their ide...

In pharmaceutical manufacturing facilities, sterilization is one of the most critical processes. Any error in sterility testing can compro...

In pharmaceutical manufacturing, HVAC system plays an important role in maintaining controlled environmental conditions that are necessary f...

Maintaining product quality and ensuring patient safety are the most important tasks in pharmaceutical industry. Unplanned events are one of...

Changes are always made in industries but in pharmaceutical manufacturing changes must be planned, documented, justified and approved. Any m...

Current Good Manufacturing Practice (cGMP guidelines) requirements are set up by the Food and Drug Administration (FDA) and serve as the ben...

GMP in pharmaceuticals plays an important role in document maintenance, compliance and product quality. Pharmaceutical documents like batch ...

In pharmaceutical manufacturing validation of manufacturing process ensures that the manufacturing process is consistent and producing a pro...

Cleaning validation is an integral part of the pharmaceutical manufacturing process. A piece of equipment itself can contaminate the product...

Computer validation planning consists of a Computer Validation Plan (approach), specific activities required to carry out the plan, and a Co...

Cleaning of pharmaceutical instruments after a product has been manufactured is critical to ensure that the subsequent products to be manufa...

It is a multi-step journey to ensure safety, efficacy and quality to bring a new drug in the market in the United States. This journal is co...

During document submission to regulatory agencies, the Drug Master File (DMF) plays an important role in pharmaceuticals in protecting confi...

Recently US FDA announced the expansion of unannounced inspections of foreign manufacturing facilities that produce medicines and medical pr...

Corrective and preventive action (CAPA) is an essential aspect of the pharmaceutical industry's quality system required by agencies such...

Sterile pharmaceutical manufacturing is the most demanding area in pharmaceutical industry. Injectable drug products and other formulations ...

Compliance quality and efficacy are non-negotiable in pharmaceutical industry. It is required to implement management practices to improve c...

Deviations in pharmaceutical manufacturing are not only manufacturing mistakes but they are threats to product quality, patient safety and r...

Cleaning of manufacturing equipment has great importance in the pharmaceutical and biotechnology industries. It is required to clean manufac...

Microbiological quality of pharmaceutical products is essential for patient safety and product stability. As we know, the sterile products a...

Compliance with good manufacturing practices is not optional in the pharmaceutical industry but is essential for public health and sustainab...