QC/QA Methodology

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IR स्पेक्ट्रोस्कोपी और इसका सिद्धांत

IR स्पेक्ट्रोस्कोपी और इसका सिद्धांत IR स्पेक्ट्रोस्कोपी क्या है और इसका सिद्धांत क्या है? एक अणु या एक रासायनिक यौगिक में यह पता लगाने के लिए कि कौन से कार्यात्मक समूह या समूह मौजूद हैं, हम IR स्पेक्ट्रोस्कोपी तकनीक का उपयोग करते हैं। आईआर स्पेक्ट्रोस्कोपी तकनीक का प्रदर्शन करने के लिए हम विद्युत चुम्बकीय स्पेक्ट्रम की एक विशिष्ट श्रेणी का उपयोग करते हैं जिसे हम IR (इन्फ्रारेड) विकिरण कहते हैं आईआर विकिरण तरंग दैर्ध्य की विभिन्न श्रेणियों से बना है और IR विकिरण के इस अनुप्रयोग को IR स्पेक्ट्रोस्कोपी के रूप में जाना जाता है क्योंकि यह पहचानने के लिए कि सभी कार्यात्मक समूह मौजूद हो सकते हैं हम IR विकिरण का उपयोग करते हैं इसलिए जब हम किसी नमूने पर आईआर विकिरण लागू करते हैं, तो हम इस तकनीक को आईआर स्पेक्ट्रोस्कोपी कहते हैं अब आइए नजर डालते हैं आईआर स्पेक्ट्रोस्कोपी के सिद्धांत पर जिस किसी भी नमूना का हम विश्लेषण करना चाहते हैं (नमूना किसी भी रूप में हो सकता है - ठोस, तरल या गैस) हम उसका नमूना तैयार करते हैं और इसे आईआर स्पेक्ट्रोफोटोमीटर में डालते हैं IR स्पेक्ट्रोफोटोमीटर वह उपकरण है

Quality control interview (Question & Answer) Part-2

Quality control interview Question.1) What is volumetric or titrimetric analysis.? Answer: It consists of determination of volume of solution of accurately known concentration required to react completely with the solution or substance to be determined. Question.2) What is standard solution.? Answer: A solution of accurately known strength is known as standard solution, standard solution are usually expressed in terms of molarity or normality. Type of standard solution: a) Primary standard b) Secondary standard Question.3) What is primary standard solution.? Answer: Primary standard is a chemical or reagents which has certain properties such as: It is extremely pure Highly stable It is anhydrous It is less hydroscopic Has very high molecular weight Can be weighed easily Should be ready to use and available Should be preferably non toxic Should not be expensive Question.4) What is extremely pure standard.? Answer: Primary standard should be extremely pure which means that, it s

Quality assurance (QA)

Quality Assurance (QA) Concept of quality assurance: Quality assurance is wide ranging concept, covering all matters that individually or collectively influence the quality of product. It is totally of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. Quality assurance (QA) therefore incorporates good manufacturing practices (GMP) and other factors, such as product design and development. Responsibility of quality assurance: To insure that pharmaceutical products are designed and developed in a way that takes account of the requirements of good manufacturing practices (GMP) and other associated codes such as good laboratory practices (GLP) & good clinical research practices (GCP) To ensure production and control operation are clearly specified in written form and GMP requirements are adopted. Managerial responsibilities are clearly specified in job descriptions. Arrangements are made for the manufactu

Customer complaint

Customer complaint Contents 1-Introduction 2-Advantage of complaint management system 3- WHO GMP guideline 4-Classification of quality detection 5-Type of complaints 6-Complaint handling system 7- Records of complaints Introduction: Complaint is define as "The statement that something is wrong or not good enough" Handling of complaint is also part of good manufacturing practices Consumer expects medicine to be safe and effective but despite best efforts to manufacture good quality products some defective formulation may reach customer Tush there should be reliable and effective system in pharmaceutical industry to deal with may any complaint to ensure the safety of customers and if necessary product may be recalled from market. Complaint in the case of pharmaceuticals may be related to the quality of product or problems in packaging. Foe example complaint of broken tablets in strips or improper labeling. WHO GMP Guidelines: All compliant related to defective products mu

Process validation

Process validation Process validation can be defined generally as a series of activities taking place over the life cycle of the product. The validation exercise establishes scientific evidence that a process is capable of robustly delivering a quality product. After 24 years the FDA modernized its process validation guidance in 2011. The changes were consistent with trends in place within the pharmaceutical industry. The views changed from validation being a point in time event to being applicable over the product life cycle. The life cycle approach to drug product management is laid down in ICH Q7. Pharmaceutical Quality Systems The FDA describes process validation as taking place in three stages. Process design Process qualification Continued process verification Process design Process qualification and continued process verification these stages align with the first three product life cycle phases to find an ICH Q7 Product development, technology transfer and

21 CFR Part 11 OR Code of Federal Regulations.

21 CFR Part 11 ( Code of Federal Regulation ) What is 21 CFR? It is code of federal regulation. It is a codification of the general and chronic rules published in the Federal Register by the head department and agency of the federal government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration called FDA. It is a part of title 21 CFR that organized the United States FDA law on electronic records and electronic signatures. Part 11 is defines the criteria under which electronic records and electronic signatures are considered trustworthy reliable and equivalent to paper records. Records are kept for a number of reasons. It happens only to those records “that persons create, modify, maintain, archive, or transmit under any records or signature requirements set forth in the federal Food, Drug, and Cosmetic Act or any FDA regulations”. Traditionally these records have been paper-based and stored in files or binders When those reco