Pharma Digest
Choice of Analytical Techniques for Cleaning Validation
Visual Inspection: Visual Inspection is the examination of the dried equipment under suitable lighting conditions by personnel with appropriate standards of vision. Generally, it is used when it has been demonstrated that a calculated MACO would leave a visible residue as it is not intuitive that a validated method of ... Read More
Classification of Elemental Impurities
The elemental impurity classes are: Class 1: The elements, As, Cd, Hg, and Pb, are human toxicants that have limited or no use in the manufacture of pharmaceuticals. Their presence in drug products typically comes from commonly used materials (e.g., mined excipients). Because of their unique nature, these four elements ... Read More
Potential Sources of Elemental Impurities
In considering the production of a drug product, there are broad categories of potential sources of elemental impurities. The following diagram shows an example of typical materials, equipment and components used in the production of a drug product. Each of these sources may contribute elemental impurities to the drug product, ... Read More
Explanation of FDA Designations
Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here’s a breakdown of some crucial designations: Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies ... Read More
EU and US GMPs | Understanding the Similarities and Differences
Similarities 1) cover a wide range of products, including RX drugs, OTCs, biologics, & medical devices. Regulations apply to all stages of manufacturing, from raw material sourcing to the final packaging and distribution. 2) require manufacturers to provide adequate training to their employees. 3) prescribe certain standards for facility design ... Read More
Amendments vs Supplements | USFDA
Both amendments and supplements are important tools in the USFDA’s regulatory process with some key differences. Amendment Initiated by the company or requested by the USFDA to make a change to an unapproved application/PAS/tentatively approved application. There are three categories of amendments: major, minor, and unsolicited. Major amendments are changes ... Read More
Key Steps in Uncertainty Determination Based on Empirical and Modeling GUM Approaches
Identify the sources of uncertainty: The first step is to identify and understand the different sources of uncertainty in the measurement process. This can include variability in the measurement instrument, environmental conditions, operator skill, and other factors. Quantify the uncertainty from each source: Once the sources of uncertainty are identified, ... Read More
Audits and Inspections in Pharmaceutical Industries | Similarities and Differences
Audit: ensure quality and compliance with systematic, independent examination and documented process Inspection: determination of conformity to specified requirements “Audit” can be seen as an umbrella term, whereas “inspection” is one concrete type of audit. Similarities 1) Both involve a review of processes, procedures, and records.2) Both aim to determine ... Read More
Common Terms Used in USFDA Inspections
Types of USFDA Inspections The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications. FDA Forms 482, 483 and 484 Establishment Inspection Report (EIR) A comprehensive report that provides a detailed ... Read More
Patents and Exclusivities | Differences and Importance
Patents Property right issued by USPTO to an inventor “to exclude others from making, using, sale, import the invention into the US for a period of 20 years from the date of filing”. Patents can be issued or expire at any time regardless of the drug’s approval status Patent information ... Read More
Environmental Monitoring in Pharmaceutical Industry
Environmental monitoring in the pharmaceutical industry is a crucial process that involves the regular assessment and control of various environmental factors within a pharmaceutical manufacturing facility. This monitoring is essential to ensure the safety, quality, and efficacy of pharmaceutical products. The pharmaceutical industry operates under strict regulations and guidelines to ... Read More