Pharma Blog
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
Guidelines on Packaging for Pharmaceutical Products | Part II
Packaging may be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use. The aspects of packaging to be considered include: Packaging materials include printed material employed in the packaging of a pharmaceutical ... Read More
Guidelines on Packaging for Pharmaceutical Products | Part I
All medicinal products need to be protected and “consequently need to be packaged in containers that conform to prescribed standards, particularly with respect to the exclusion of moisture and light and the prevention of leaching of extractable substances into the contents and of chemical interaction with the contents. The complexity ... Read More
Dietary Reference Intakes for Calcium and Vitamin D
Calcium and vitamin D are two essential dietary supplement for their role in bone health. Institute of Medicine (IOM) share the nutrient reference values of calcium and vitamin D, known as Dietary Reference Intakes (DRIs) for calcium and vitamin D. Calcium Salt form conversion Primary functions Essential role in blood ... Read More
Tips for Laboratory Design in Pharmaceutical Industry
1. Consider the purpose and requirements of the lab: Before designing the lab, clearly define its purpose and the specific requirements it needs to fulfill. This will help in determining the layout, equipment, and space needed. 2. Optimize space utilization: Efficiently utilize the available space by carefully planning the layout ... Read More