Pharma Digest
FDA Requirements For OTC Drugs
An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctor’s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the ... Read More
Commissioning, Qualification, and Validation (CQV) in Pharmaceutical Industry
Commissioning, Qualification, and Validation (CQV) is one of the most important phases in achieving cGMP and regulatory compliance for a pharmaceutical manufacturing facility. CQV is a systematic approach to ensuring that facilities, equipment, and processes meet the required quality and regulatory standards. Each phase serves a specific purpose in the ... Read More
Hold Time Management in Pharma Manufacturing
Holdtime can be considered as the established time period for which materials (dispensed raw materials, intermediates and bulk dosage form awaiting final packaging) may be held under specified conditions and will remain within the defined specifications. 21 CFR 211.111 Time Limitations on Production states: When appropriate, time limits for the ... Read More
Hold Time Study Protocol for Pharmaceutical Products
A Hold Time Study Protocol is a document that outlines the procedures and criteria for conducting a hold time study in a pharmaceutical industry. 1. Objective \ Scope 1.1. Hold time study data shall give the assurance of the maximum allowable hold times for bulk and in-process drug products. Generally, ... Read More
Difference Between Extractables and Leachables
In the intricate world of biopharmaceutical manufacturing, the presence of extractables and leachables poses a significant challenge, potentially tarnishing the purity of invaluable drug products. The FDA offers precise definitions for these two critical terms: Extractables These are compounds that can be meticulously drawn out from the container closure system ... Read More
Oral Semaglutide (Rybelsus) | Drug Digest
Pharmacologic Category (Oral Diabetes Medicine): Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist Mechanism of Action: Stimulates insulin release in the presence of elevated blood glucose. Suppresses Glucagon (inhibits hepatic glucose production); thereby reducing both fasting and postprandial glucose. It delays gastric emptying (slower absorption of sugar and promotes the feeling of fullness). ... Read More
Knowledge Assessment of Pharmaceutical Sciences (KAPS) Exam
The KAPS (Knowledge Assessment of Pharmaceutical Sciences) exam check your pharmaceutical knowledge and understanding to ensure safe and effective practice in an Australian setting. It is open for all the overseas-trained pharmacists who have completed an approved 4 years pharmacy program after 1 January 2006. Skills Assessment Structure The process ... Read More
Role of Analyst While Performing Method Validation
What should an analyst do during analytical method validation? The responsibilities of an analyst /chemist during method validation typically include the following: Designing the Validation Protocol: The analytical chemist is responsible for developing a detailed validation protocol that outlines the objectives, scope, acceptance criteria, and experimental procedures for method validation. ... Read More
Errors or Incidences During Analytical Method validation
Incidences are any unintentional/ unexpected event that occurs during analysis, discovered during analysis, and after analysis that may adversely affect the data quality and the result. Lets quickly go some of the common incidences which are observed during method validation activity. Instrument related: Analyst related: Chromatography related: Sample related: Read ... Read More
Guidelines on Packaging for Pharmaceutical Products | Part IV
Labelling Throughout manufacturing, a succession of specific outer labels are applied to the container of the medicinal product. The level of processing is indicated by the following words:— quarantine— storage— distribution Specifications for labels for finished drug products are defined in the WHO guidelines on GMP for pharmaceutical products. Written labels on the ... Read More
Guidelines on Packaging for Pharmaceutical Products | Part III
Containment The design of high-quality packaging must take into account both the needs of the product and of the manufacturing and distribution system. Protection The packaging must protect the product against all adverse external influences that may affect its quality or potency, such as: Stability For primary packaging, it is ... Read More