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…
ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, and the ‘+’ refers to Complete, Consistent, Enduring, and Available. These principles form a critical checklist to ensure that data is trustworthy and reliable. Here’s a brief overview: By embracing the ALCOA+ principles, organisations can significantly enhance their data integrity assurance,…
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international organization that brings together regulatory authorities and the pharmaceutical industry to develop and promote harmonized guidelines and standards for the development, registration, and post-approval of pharmaceutical products. Structure of the ICH 1. Management Committee: Comprised of regulatory…
The roles and responsibilities of an industrial pharmacist include (but not limited to): R&D Scientists Production Pharmacist QC Pharmacist QA Pharmacist Validation Pharmacist Regulatory Pharmacist Compliance Pharmacist Warehouse Pharmacist Read also: Pharmaceutical QA Interview Q&A Pharmaceutical Production Interview Q&A
