THE SCIENCE AND QUALITY MANAGEMENT SYSTEM

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As all know Data Integrity is very hot topic for all Pharmaceutical Industries and it is must to follow Data Integrity Policy in Manufacturing Plant. What this policy should include and what is the minimum requirement to add in Data Integrity Policy? Herewith in my article I have added definitions, general requirements and ALCOA principle in very short and easy to understand form. This information may help you to impart training on Data Integrity and also help you us implement at your facility. General Statement (Company Name), has established, documented, implemented and maintained a Quality Management System and continually improve its effectiveness as per requirements of ICH guideline, EU-GMP Guideline and 21 CFR Part 210 and 211 standard. To implement the QUALITY MANAGEMENT SYSTEM (QMS) Identifies the processes needed for the QMS. Necessary processes are documented in procedures & work instructions/SOPs. Determines the sequence & interaction of these processes. This is done

  1. Question: Regarding visual inspection of surfaces in Annex 15: Is during operator qualification a training on the relevant SOP sufficient or should a training, comparable to those for visual inspection operators, be established (incl. periodic eye sight test)? Answer: A solely theoretical SOP-training is not sufficient. Practical training with surface samples spiked with different concentration of the respective product needs to be performed. This needs to be performed by collecting data to demonstrate down to which level of residues visual cleanliness can be detected. 2. Question: Are direct sampling methods necessary for transfer lines or other inaccessible equipment parts? Those parts can neither be tested visually nor via swab testing. Would final rinse testing be sufficient? Answer: This clearly depends on factors like pipe length, flow conditions, percentage of surface area that can't be inspected and should be addressed in a risk assessment. Additional measurements like

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  As per ICH guideline Q2(R1), the accuracy is defined as below “The accuracy of an analytical procedure expresses the closeness of agreement between the value which is accepted either as a conventional true value or an accepted reference value and the value found. This is sometimes termed trueness.” Accuracy should be assessed over a minimum of  3 concentration  levels covering the specified range; by making  triplicate  preparations at each level. Accuracy is one of the most critical parameter in method validation. Accuracy confirms the suitability of method to the greatest extent and hence method developer must design suitable extraction procedure to assure accurate quantification of analyte in presence of sample matrix. The diluent and extraction techniques such as shaking/sonication/heating determines the method’s accuracy. The drug product containing drug retarding polymers, such as HPMC, pose great challenge to recovery and such formulations must be handled with utmost precautio

  Ethics, risk and compliance (ERC) has become a priority for organizations around the world, more so for pharmaceutical companies. The pharma sector, by nature, is volatile and given this, individual companies have put in considerable efforts to develop robust ERC frameworks and guidelines to be abided to. Initially considered as different departments, ERC has evolved to become a single function and has been a strategic enabling partner for organizations. The need for an upgrade The pharmaceutical industry is rapidly changing and this ever shifting landscape calls for an upgrade in the ERC function as well.  The truth is that without modernizing ERC operations, it will eventually become difficult for pharma companies to leverage ERC’s expertise. We are witnessing the way regulatory requirements are becoming more stringent and the growth in the regulators’ precision and speed to identify risks. As these factors increasingly come into play, the ERC function will have to become more agil

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  As per ICH Q2(R1), precision is defined as below, “The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogeneous sample under the prescribed conditions.” Precision should be investigated using homogeneous, authentic samples. The precision of an analytical procedure is usually expressed as the variance, standard deviation or coefficient of variation of a series of measurements. Precision may be considered at three levels- repeatability, intermediate precision and reproducibility.  Repeatability Variation that occurs when repeated measurements are made under absolutely identical conditions such as, same analyst–same instrument-same lab-same day. Reproducibility Variation that occurs when different conditions are used to make the measurements such as, different analyst–different instrument–different lab-different day. Intermediate precision Variation that occurs w

  Specificity is one of the method validation parameter. Specificity defined by ICH Q2(R1), is as below, “Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.” So in the  context of specificity, the interested component must get explicitly assessed in presence of other sample components. To explain it further, let us take an example of a finished product such as tablets. Test solution of tablets consists of interested compounds (such as API and impurities) as well as the components which are of no interest (such as excipients). The excipients, though they are of no interest, one can’t completely remove them from test solution and hence it is important to assess their impact on quantification of analyte. Also, in case of assay analysis, the impurities will become the components of no interest and one must assess impurity interference while performing specificity. Let us understand how specificity is conducted f

  Being a manager, you must be vigilant. While working in a laboratory, analysts come across various activities ranging from analysis, reporting and calculation. Under the guidance of manager, analyst takes utmost care during each and every step but more often lose focus during calculation. Managers must clear doubts about calculations and shall teach analyst how to think logically about different factors used during calculation. In today’s article I am going to walk you through few familiar equations used in laboratory along with precautions to be taken while selecting values of few common factors. Standard potency:  The standard solution is used for calculation of assay, residual solvents and impurities. The potency of the standard needs to be considered during calculation. The potency of standard ‘on as such’ or ‘as is basis’ must be considered in case if standard is not dried before use. The potency on ‘dried basis’ must be used in case if standard is dried before use. If the refer