THE SCIENCE AND QUALITY MANAGEMENT SYSTEM

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  The Food processing industry has huge growth potential and the country’s agro-climate zones provide a fertile ground for various plant-based edibles that cater to indigenous people and also global consumers, experts said. Experts at a conference organised by trade body PHDCCI noted that food processing is the fifth largest sector of the country’s economy and spoke about various challenges being faced by the employment-intensive industry. ”The contribution of agriculture towards GDP is far low as compared to the number of people involved in it. Food processing is the fifth largest sector of the country’s economy and contributes 13 percent to our annual GDP,” former President and Mentor MSME Mentoring and Guidance Centre, PHDCCI, Anil Khaitan, said. The 127 agro-climate zones in the country provide a fertile ground for various plant-based edibles that cater to indigenous people and also global consumers, Khaitan said while participating in a virtual seminar on ”Promoting Entreprene...

  The job of the leader is to grow. Grow in knowledge, patience, consistency and sympathy. The role of team leader is very crucial in achieving error free execution in quality control. Team leader not only allocates work or reviews document but also helps on remedial action plan to come out of the errors that have happened during experiment. The quality of data generated is dependent on system & procedures but more often on the mindset of a leader. Many times, the flaw in the system leads to non conformities. The job of the leader is to identify such flaw immediately and put mitigation plan in action to avoid further damage. There is likely any chance of data integrity issue once the system is perfected and people are trained. Pharmaceutical companies’ pays high attention towards data integrity issue as it has direct impact on company’s reputation, market share and business potential. With ever increasing regulatory demand, it is also important for pharmaceutical companies to d...

  Analytical method validation is one of the most important activity in product life cycle. I have tried to summarize steps involved in method validation. Step-1: Preparation of method of analysis: Based upon final method development experiment and upon confirmation of few critical validation parameters (such as precision, accuracy, forced degradation etc...), you need to prepare final method of analysis. Step-2: preparation of Specification: Upon finalization of process and formula for product, now it is time to prepare specification. The specification must be prepared in consultation with pharmacopoeia of target geography, critical process and product attributes and any additional regional requirement.  Step-3: Preparation of concentration matrix: Before heading to protocol preparation, it is highly important to map the concentration of sample and standard for various method validation parameters. Concentration matrix gives huge guidance on preparation of...

  Interaction of the analyte and its matrix with the stationary phase of the column can result in contamination of the column and change in the column characteristics. The chromatographic performance of a contaminated column can be different from an uncontaminated column. Column contamination can result in failure to meet system suitability requirements, poor peak shape, baseline disturbances, baseline drift, high column back pressure, etc. In such cases, regeneration procedures can often restore the column to its original working condition. The regeneration procedure for the column depends upon the nature of the column and contaminants. If the column exhibits high back pressure, first determine the cause of the high back pressure - whether it is due to the column or the HPLC/UPLC system. This can be done by checking the back pressure when the column is connected to the system and disconnected from the system. Always disconnect the column from the detector during this check. If the...

  The purpose of method development is to get simple, selective, precise, accurate and robust method in place. Among many factors, the concentration of analyte plays vital role in sensitivity, precision, accuracy and linearity of method. And hence it becomes very important to define optimum concentration for standard and sample to yield optimum response! Most of the method developers prefer to use diluted standard for evaluation of system suitability and for quantification of impurities. The system suitability is determined with the help of peak tailing, theoretical plates and or %RSD of diluted standard. The concentration of standard solution has major role in determining %RSD of the replicate standard injections. More is the concentration-less will be the %RSD and vise a versa. So, one can understand that the higher concentration of standard is good to yield lower %RSD for replicate standard injections. But the %RSD for standard is not the only factor which needs to be considered...

Chromatographic peaks are generally integrated by using chromatographic operating software. Empower, Chromeleon, OpenLab are few examples. Analyst must prefer automated integration and make adjustments manually, if necessary. The analyst is expected to use proper judgment in selecting methodology for peak integration. Peak integration is important as end result is highly influenced by the way it happens. Incorrect results may be obtained due to improper peak integration. The failure of the software to appropriately integrate a peak is usually obvious from visual inspection of the chromatogram (at an appropriate scale). Various errors can occur which include, but are not limited to, peak splitting, adding area due to a co-eluting peak, failure to detect a peak, excessive peak tailing,   failure of the instrument response to return to baseline or a rise in the baseline, and failure to separate peaks. Manual integration may be employed to correct an improper integration performed...

  Water is widely used as a diluent during GC analysis due to its compatibility with packed as well as capillary columns. In addition, almost all residual solvents give highest response when analyzed using GC-HS with water as a diluent. If you have also noticed the same- please share your experience. The reason behind high response for residual solvents with water as diluent is the difference in polarity of water and organic solvents. Most of the organic solvents are non-polar –where as water is highly polar. Due to difference in polarity, high amount of organic solvent leaves water and become available in the headspace of the GC vial. Further the high amount of organic solvent’s vapor gets injected into GC column and result into higher response. It has been also seen that sodium sulphate is added during standard and sample preparation when water is used as a diluent. The addition of sodium sulphate further saturates water and helps in taking out organic solvent from solu...

  Which one is your favorite technique in case of GC? Is it liquid injection or headspace? Mine is the headspace, as headspace can outperform liquid injection in many ways. #1  For residual solvent analysis, the liquid injection can’t be used in case if sample does not dissolve completely. However, the headspace can be used even though the sample does not dissolve completely in given diluent. #2  The liquid injection will introduce all the components present in a sample solution on to column and may end up damaging column if few of the injected compounds do not vaporize.  However, headspace allows injection of vaporized components of sample solution and will not introduce non-vaporized components on to column and eventually protect column from contamination and harmful components. #3  The liquid injection technique gets affected by viscosity of the sample solution. Whereas, headspace will never get impacted due to viscosity of sample solution. #4  The liqui...

  Analytical methods development plays important role in drug discovery, generic product development and manufacture of pharmaceuticals. Method development is the process of identifying set of parameters which provides desired analytical performance. Below are the important parameters which needs to be considered during method development. SOLUBILITY PROFILE: Solubility of interested compound/API in different solvents such as water, acetonitrile, methanol, isopropyl alcohol etc. is useful while selecting diluents for standard solutions and extraction solvents for test solutions. The pH solubility data of API also helps in selecting diluent during sample and standard preparation. BCS and saturation solubility data is used for selecting media for dissolution method. ANALYTICAL PROFILE: The spectral profile is useful in understanding the absorption characteristics, which helps in selection of detector and the wavelength for analysis. Understanding the degradation profile will help in ...

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Establishing acceptance criteria during method validation: A method validation is necessary when a new method has been established and is supposed to use routinely for the intended purpose. There are requlatory requirements and guidelines to be applied to take criticali points into account during method validation. i The ICH Q2(R1) is one of them. This guideline "Validation of analytical procedures: text and methodology", published by the ICH, offers help with respect to number of parameters to be considered during validation, but more often not on the acceptance criteria. This article is aimed to provide quidance on the acceptance criteria which are accepted by most of the regulators.

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Indian pharma's dependence on Chinese imports can be reduced only by developing a domestic ecosystem that boosts and supports drug manufacturers A global phenomenon that the Covid-19 pandemic exposed was the world’s reliance on China for various manufactured goods and raw materials. For India, its dependence on its eastern neighbour for numerous goods—electronics and electricals, automobile components and even personal protective equipment (PPEs)—was a stark reminder of the country’s lack of manufacturing prowess. One of the sectors in which this was acutely felt was the pharma industry, which imports almost 70 percent of its requirement of APIs (active pharmaceutical ingredient)—also known as bulk drugs, they are the active ingredient in medicines—from China. India imports APIs from the US (4 percent), Italy (3 percent) and Singapore and Hong Kong (2 percent each) as well. This, despite India contributing 20 percent of the world’s generic medicines in terms of volume, and supp...

The International Council for Harmonisation (ICH) on Thursday  announced  its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month  public consultation  to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the document in October.   EMA also released a  report  from its meeting in June to gather input from patients, healthcare professionals and researchers to inform an upcoming review to ICH’s good clinical practice (GCP) guideline, ICH E6(R3).   Earlier this week, Health Canada announced it has implemented both  ICH M9: Biopharmaceutics Classification System (BCS)-Based Biowaivers , which provides a harmonized approach to biopharmaceutics classification of drugs and provides recomme...