Trek Pharma

  CDSCO: CENTRAL DRUGS STANDARD CONTROL ORGANIZATION The Central Drugs Standard Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices in India. Here are the general guidelines for product registration with the CDSCO: Application Submission: The application for product registration must be submitted in the prescribed format along with the necessary documents and fees. Review of Application: The CDSCO will review the application and conduct a technical evaluation of the product to determine its safety, efficacy, and quality. If the application is found to be incomplete or insufficient, it will be returned to the applicant for further information. Site Inspection: The CDSCO may conduct a site inspection of the manufacturing facility and other relevant sites to ensure compliance with Good Manufacturing Practices (GMP) and other regulations. Import and Export Licenses: If the product is being imported or exported, the applica...

  POLYMORPHISM DEFINITION AND TYPES OVERVIEW Polymorphism definition: Polymorphism is the ability of a substance to exist in multiple crystal structures or forms, also known as polymorphs. These crystal structures may differ in their molecular arrangements, which can result in differences in the physical and chemical properties of the substance. Polymorphism is a widely observed phenomenon in the fields of chemistry, materials science, and pharmaceuticals. In materials science, polymorphism can affect the properties of a material, such as its strength, density, and melting point. In chemistry, polymorphism can affect the reactivity and stability of a substance. In pharmaceuticals, polymorphism can affect the bioavailability, stability, and efficacy of drugs. Polymorphism is often studied and analyzed using analytical techniques such as X-ray diffraction, differential scanning calorimetry, and infrared spectroscopy. The identification and control of polymorphism is...

  STABILITY TESTING DURING PRODUCT DEVELOPMENT In order to include quality, efficacy, and safety into a medicine formulation, stability testing of pharmaceutical goods is a complicated collection of processes requiring significant expense, time consumption, and scientific skill. Understanding the drug development process and the numerous activities and milestones that are essential to a thorough development plan is the only way to guarantee the scientific and financial success of a pharmaceutical product. The pharmaceutical analysis and stability tests that are necessary to ascertain and ensure the identity, potency, and purity of ingredients as well as those of the formed products are among the most crucial tasks during the developmental stages. A pharmaceutical product's capacity to maintain its physical, chemical, microbiological, toxicological, protective, and informational requirements in a certain container or closure system is known as stability. In other words, it refers to...

                                     PREFORMULATION STUDIES Preformulation definition: It is defined as the phase of research and development in which preformulation studies characterize physical and chemical properties of a drug molecule in order to develop safe, effective and stable dosage form. Objectives: To establish the physico-chemical parameters of a new drug entity To determine its kinetics and stability To establish its compatibility with common excipients \it provides insights into how drug products should be processed and stored to ensure their quality. PREFORMULARION PARAMETERS OR PROPERTIES OR PROTOCOL OF PREFORMULATION OR PRINCIPLE AREAS PREFORMULATION physico-chemical properties: Organoleptic properties Particle size and shape Surface area Purity Bulk characterization: Crystallinity and polymorphism Hygroscopicity Particle size characterizati...

SCALE-UP AND POST-APPROVAL CHANGES (SUPAC) The term "SUPAC" refers to the scale-up procedure as well as changes made to the composition, manufacturing procedure, manufacturing equipment, and change of location after approval. During the post-approval period, pharmaceutical sponsors of new drug applications (NDAs), abbreviated new drug applications (ANDAs), and abbreviated antibiotic drug applications (AADAs) who intend to change a semisolid formulation's components or composition, manufacturing (process and equipment), scale-up/scale-down of manufacturing, and/or the site of manufacture may use the recommendations provided in this guidance. This advice covers topical modes of administration for non-sterile semisolid preparations (such as creams, gels, lotions, and ointments). The recommendations outline the levels of change, the recommended in vitro release tests and/or in vivo bioequivalence testing to support each level of change, (3) recommended CMC tests to support ea...