Root Cause Analysis (RCA) is a problem-solving methodology that steps you through the RCA process. Each RCA process phase has a range of root cause analysis tools that you can use. The RCA process starts at the problem event then moves through evidence collection, investigation, analysis, developing corrective actions to address the problem or…
Cleaning validation is a regulatory requirement in pharmaceutical industry. It ensures that the cleaning process can removes the API residue from machine or equipment and make ready for next product. In this article we discuss about good cleaning validation practice in pharmaceutical industry. 1. Define the scope of the cleaning validation study Determine which…
Pharmaceutical tablets must meet their physical specifications and quality standards for ensuring safety and efficacy. These include weight variation, content uniformity, hardness, thickness, friability, disintegration, and dissolution. These factors must be controlled during production (in-process controls) and verified after the production of each batch to ensure that established product quality standards are met. Weight…
Tablet is the most common and convenient dosage form. Itcontains active ingredient(s) and excipients. The various types of tablets aredescribed as follows: Compressed Tablets In addition to the API(s), compressed tablets usually contain a number of pharmaceutical excipients, including diluents or fillers, binders or adhesives, disintegrants or disintegrating agents, anti-adherents, glidants, and lubricants to prepare…
To ensure the quality of the drugs produced, strict guidelines and regulations shall be in place and followed by the pharmaceutical companies. What are Good Manufacturing Practices Violations? GMP stands for Good Manufacturing Practices and it is a set of regulations that must be followed when manufacturing pharmaceuticals. There are a few different types…
GMP stands for Good Manufacturing Practices in pharmaceuticals, it means to follow the regulatory standards during manufacturing of pharmaceutical products. There are several guidelines for good manufacturing practices worldwide like WHO , FDA and EU. These guidelines have recommendations for almost all departments of pharmaceutical companies like manufacturing, quality control, storage and distribution. …
The main similarities and differences between Quality Control (QC) and Quality Assurance (QA) are as follows: Similarities 1. Both quality control and quality assurance are essential components of the pharmaceutical industry. 2. Both aim to ensure that pharmaceutical products meet the required standards and regulations. 3. Both involve monitoring and evaluating processes to identify any…
Elaboration Focus Development ICH developed through the collaboration of regulatory authorities and pharmaceutical industries. ISO developed through the technical committees. Scope ICH concentrates on technical and scientific aspects of pharmaceutical product development and registration. ISO covers various management system, processes, and requirements. Applicability Often mandatory for regulatory compliance in countries…
