THE SCIENCE AND QUALITY MANAGEMENT SYSTEM

Hydrogen peroxide shelf life is 3 years unopened or 6 months opened. The shelf life is shorter for more concentrated solutions. Like many household chemicals, hydrogen peroxide (H 2 O 2 ) has a  shelf life . Over time, peroxide breaks down into water and oxygen. The shelf life of a bottle of unopened household peroxide is about 3 years, while it’s only good for 1 to 6 months after the seal is broken. Household peroxide is between 3% and 7% hydrogen peroxide in water. More concentrated peroxide solutions, such as the 30% and 35% peroxide used in labs and for hair developer, degrade more quickly. For these solutions, the shelf life is about 1 year unopened, but only 30 to 45 days after opening for peak effectiveness. Factors That Affect Peroxide Shelf Life Hydrogen peroxide is a highly reactive molecule, which is why it has a shelf life. Hydrogen peroxide is inherently unstable, so it degrades no matter what. However, the rate of decomposition depends on several fac...

ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk is now fully implemented and makes available a variety of approaches to control potentially genotoxic impurities (PGIs) based on the maximum daily dose, duration of use, and indication of the drug product. The limit to which a PGI is controlled, based on these factors is defined as the threshold of toxicological concern or TTC.   Once the need for control of a PGI is identified and the standardized deficiency from DLAPI is issued, a firm can use any of the following approaches as a control strategy in their response:  1) Use Options 1-4 provided in ICH M7 2) Provide negative (Q)SAR data 3) Provide a complete AMES study This poster provides a survey of the choices DMF holders have submitted to the Agency to control PGIs based on ICH M7.  Click here to view more

A Threshold of Toxicological Concern ( TTC ) concept was developed to  define  an acceptable intake for any unstudied chemical that poses a negligible risk of carcinogenicity or other toxic effects. ... This guidance bases acceptable intakes for mutagenic impurities on established risk assessment strategies. Click here to view the guidelines

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This article offers an overview of the clinical trial application process and guidance on the regulatory obligations pursuant to Part C, Division 5, of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” in Canada. The authors focus on clinical trial applications only for biologics (schedule D) and pharmaceuticals (schedule F). They provide information on a range clinical trial submission requirements and communication with Health Canada’s relevant directorates and offices.   Introduction The Health Products and Food Branch (HPFB) of Health Canada is the scientific and regulatory authority for health products and food in Canada. 1  The investigational product classification for pharmaceuticals or biologics is designated by the directorate within HPFB, which will review and authorize the clinical trials. 2  Clinical trial inspections are overseen by the Regulatory Operations and Enforcement Branch ( Figure 1 ).   Part C, Divis...

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This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.   Introduction Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a structured CAPA process and which can be resolved in alternative ways. The concept of a risk-based approach is not in itself new ‒ it is explicit in the International Organization for Standardization’s (ISO’s) 13485:2016 standard 1  and is included in the preamble to US Quality System Regulation (comment 159). 2  Nevertheless, many medical device companies still take a conservative approach and apply a one-size-fits-all method, subjecting most issues to a rigid and heavily documented CAPA process.   In conduc...

Elemental impurities are traces of metals carried from raw materials, residual catalysts, manufacturing equipments, process water, excipients, containers that can be observed in finished drug products.  These elemental impurities do not have any therapeutic effect  and is harmful to patients due to their toxicity beyond certain limit. The presence of trace elements were tested classically by using USP's Heavy metals test,  <231> , which uses as a colorimetry test by forming as a sulphide precepitate with elements. In the last decade, PDE (permitted daily exposure) of almost all elements are found which leads to monitor and  control the individual elements in the drugs by measuring their level by using modern instruments like ICP OES, ICP MS etc. ICH developed a  guideline specifically on Elemental impurities as Q3D and list the PDE values for each element. Based on PDE value and the route of administration ( orals, parenteral, nasal)  values...