Quality Assurance

Annual Product Quality Review as per EU Pharmaceutical Guidelines and RegulationsAnnual Product Quality Review

SOP Instructions for Preparing an Annual Product Quality Review (APQR) for Oral Solid Dosage Forms as per EU Pharmaceutical Guidelines and Regulations This SOP outlines the procedures for preparing an Annual Product Quality Review (APQR) for oral solid dosage form pharmaceutical products, adhering to EudraLex – Volume 4 Good Manufacturing Practice (GMP) for Medicinal Products

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Fatty Acid Oxidation: Unleashing Energy from Lipids ( Metabolic Pathway )

In the bustling world of cells, energy is the driving force behind every process, from muscle contractions to protein synthesis. While glucose is often considered the primary energy source, our bodies also have the ability to extract energy from lipids, particularly fatty acids. This process is known as fatty acid oxidation and it plays a

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Ensuring the Potency and Purity of Pharmaceutical Capsules: A Comprehensive Guide to GMP Implementation

Ensure the safety and efficacy of your pharmaceutical capsules with this step-by-step guide to GMP compliance for capsule manufacturing in India. Introduction: In the pharmaceutical industry, Good Manufacturing Practice (GMP) plays a pivotal role in safeguarding the safety and efficacy of medications. GMP regulations are designed to establish consistently high-quality standards for the manufacture of

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Critical quality attributes (CQAs) in the compression stage of tablet manufacturing

The compression stage is a critical step in the tablet manufacturing process. During this stage, the powders or granules that have been blended and mixed in the previous stages are compressed into tablets using a tablet press machine. The compression process involves applying high pressure to the powder mixture, which forms the tablet and gives

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Hold Time Study Report for Dirty Equipment in the Injection Ampoule Section

A hold time study report is an essential part of the quality control process that determines the maximum time for which a product can be held or stored under specified conditions. In the case of dirty equipment in the injection ampoule section, this study is critical for ensuring that the equipment does not introduce contamination

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Cleaning Validation in Pharmaceutical Industry : Essential Tips and Best Practice

By following these tips and best practices, companies in the pharmaceutical industry can ensure that their cleaning processes are effective and compliant with GMP requirements. By maintaining a clean and well-controlled environment, companies can help prevent contamination and ensure the quality and safety of their products.

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