Pharma Digest
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
Methods of Sterilization and Depyrogenation
Methods of Sterilization Heat Sterilization This method involves the use of high temperatures to kill microorganisms. It can be achieved through: Radiation Sterilization This method uses ionizing radiation, such as gamma rays or electron beams, to destroy microorganisms. It is commonly used for sterilizing medical equipment, pharmaceutical products, and certain ... Read More
Guidelines on Good Distribution Practice of Medicinal Products
Quality Management The organisation’s management is responsible for the quality system, which requires their leadership and active participation supported by staff commitment. The Responsible Person is to ensure that a Quality Management System is implemented and maintained. The Management is to ensure that all parts of the quality system are ... Read More
Predictive Maintenance and Machine Learning in GMP Facilities
Predictive maintenance (PdM) is a general method that uses ongoing analysis of operational data to determine when equipment maintenance will be required. When applied appropriately, it can reduce maintenance expenses while improving reliability. Maintenance of GMP facilities is necessary to ensure that they operate in a qualified and validated state ... Read More
Difference Between OOS and Deviation
OOS (Out of Specification) and deviation are terms commonly used in the context of quality management, particularly in pharmaceuticals industries. Here’s a brief overview of each term: Out of Specification (OOS) Definition: An OOS result occurs when the test results of a sample fall outside the established acceptance criteria or ... Read More
Manual Titration to Automated Titration | USP Recommendations
While several titration methods for assays in compendial monographs are being converted to chromatographic methods or other quantitative procedures, titration still plays an important role in pharmaceutical analytical procedures and processes. Several applications, such as distinguishing between carbonate and bicarbonate or monobasic and dibasic phosphate salts, are only feasible by ... Read More