We are delighted to invite Eminent Scientists, Academicians and Researchers to submit their original research and review article for publication Research & Reviews: Journal of Pharmaceutical Quality Assurancean an International journal publishing quarterly (Online and Print version) on the aspect of Pharmaceutical Quality Assurance an effective scientific reading and public view with an aim to reach the world wide researchers.
The manuscript would be considered under the specific branches of Pharmaceutical Quality Assurance. GCP (Good Clinical Practices) Pharmaceutical Analysis Formulation Development Validation GLP (Good Laboratory Practices) GMP (Good Manufacturing Practices) Other guidelines and regulations: Education, Training, General quality management and measurement .
Good Manufacturing Practices
A good manufacturing practice is a system for ensuring that products are consistently produced and controlled according to quality standards. Good manufacturing practice is designed to minimize the risks involved in any pharmaceutical-production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff.
Good Manufacturing practice provides a high level of assurance that medicines are manufactured in a way that ensures their safety,efficacy and quality. Good manufacturing practice helps in the manufacture of medicines to comply with the marketing authorization.
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Pharmaceutical Guidelines
The pharmaceutical guidelines include all the aspects that need to be followed according to systematic procedures in the Maintainence of pharmaceutical industry. Pharmaceutical guidelines includes guidelines about quality control, quality assurance, microbiology, production and regulatory updates provided by regulatory agencies.
The pharmaceutical guidelines help to provide assurance of the methods used to manufacture medicines which are a priority health needs so that they meet acceptable standards of quality,safety, efficacy.
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Research and Reviews:Journal of Pharmaceutical Quality Assurance, Applied Pharmacy,International Journal of Research and Development in Pharmacy and Life sciences, American Journal of Health-System Pharmacy, American Journal of Pharmacy Benefits.
Pharmaceutical Regulations
The realistic and effective laws and pharmaceutical regulations that are needed for the pharmaceutical sector because pharmaceuticals is concerned with the whole population and include many patients, health providers, manufacturers, and salespeople. So the serious consequences, including injury and death, can result from the lack or misuse of medications so there needs to be pharmaceutical regulations because the consumer has no way to determine product quality.
The pharmaceutical regulations are designed by the respective governments of different countries which shows their control over the pharmaceuticals and extreme economics related to it.They also deal with the highfixed costs of development and relatively low incremental costs of production.
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General Quality Management
A quality management system (QMS) is a collection of business processes focused on achieving quality policy and quality objectives to meet customer requirements. Quality management system is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management. Early systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling.
General quality management system is an integral component of organisation operational strategies.It plays important role at both micro and macro level.It is an important part of management culture,particularly in new enterprises characterized by the supply chain,e-commerce etc.
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Pharmaceutical Quality Control
The term pharmaceutical quality control refers to the sum of all procedures undertaken to ensure the identity and purity of a particular pharmaceutical. Pharmaceutical quality control is an essential operation of the pharmaceutical industry. Drugs must be marketed as safe and therapeutically active formulations whose performance is consistent and predictable. New and better medicinal agents are being produced at an accelerated rate.
Pharmaceutical quality control helps to make sure that the product meet standards of quality and safety.The quality control is conducted by implying many methods that helps in improving the process and productivity.
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Pharmaceutical Validation
Pharmaceutical validation is the process of establishing documented evidence which provide high degree of assurance that a specific process or equipment will consistently produce a product or result in meeting its pre-determined specification and quality attributes. Pharmaceutical validation is the key process of quality assurance.
The pharmaceutical validation simply means assessment of validity of providing effectiveness. It deals with process optimisation,assurance of quality,reduction of quality cost,increased output.
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Quality Control
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. Quality control is similar to, but not identical with, quality assurance .It is a process by which entities review the quality of all factors involved in production.
Quality control is the totality of features and caharcteristics of a product or service that bears on its ability to satify the given needs of the customer.It helps to establish good methods for production of quality and economical products that are acceptable to the customer.
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Quality Assurance
Quality assurance (QA) is a way of preventing mistakes or defects in manufactured products and avoiding problems when delivering solutions or services to customers; the ISO 9000 defines as part of quality management focused on providing confidence that quality requirements will be fulfilled. In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements.
Quality assurance includes all those planned and systematic operations implemented to provide adequate confidence that an entity will fulfill it's quality standards.
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Drug Quality Standards
Drug quality standards is the process of controlling and minimizing the side effects of drugs are the key issues in assuring the safety of drugs therapy. Drug quality standards is widely agreed that pharmaceuticals should be manufactured to a high standard of quality, because they are frequently critical to human health, and because the consequences of quality problems such as sub-potency, lack of sterility, or product mix-ups can be so devastating. So drug quality standards are developed to maintain the efficacy and quality of drugs.
Drug quality standards helps to achieve quality standards for a product, continuous quality improvement, ensure complaince with statuatory and safety requirements.
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Product Testing
Product testing, also called consumer testing or comparative testing, is a process of measuring the properties or performance of products. The theory of product testing is that since the advent of mass production manufacturers produce branded products which they assert and advertise to be identical within some technical standard.
Product testing is the process of providing evidence on how the quality of how the quality of a drug substance varies with the time under the influence of environmental factors such as light, temperature, humidity and to re-establish a retest period for drug substance and to provide a shelf life period of drug substance.
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Quality Packing
The quality packaging refers to the process of covering, wrapping of goods in suitable packages. Quality packaging is essential as it offers safety to the products until they reach the consumers. The quality packaging is an important aspect of pharmaceutical industry and packaging is designed on the basis of consumer’s convenience and appeal, marketing considerations etc.
The quality packaging helps to safeguard a medical product against several factors such as shock and vibration,dynamic and static compression,contamination,pack piercing, snagging etc.
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Drug Evaluation
Drug evaluation is defined as any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Drug evaluation, sometimes referred to as drug utilization review, is a system of continuous, systematic, criteria-based drug evaluation that ensures the appropriate use of drugs.
Drug evaluation is a method of obtaining information to identify problems related to drug use and if properly developed, it also provides a means of correcting the problem and thereby contributes to rational drug therapy.
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Resampling
Resampling is the mathematical technique used to create a new version of the image with a different width and/or height in pixels. Increasing the size of an image is called up sampling; reducing its size is called down sampling. Resampling is a crucial step in the pharmaceutical industry.
Resampling involves analyzing a specimen from any additional units collected as a part of the original sampling procedure or form a new sample collected from the main batch.
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Microbiological Testing
A microbiological testing is a laboratory test that checks for the presence of microorganisms in a sample provided to the laboratory. Microbiological testing is used for product safety, to look for signs of contamination in products that will be sold to the public, and for lab control, to confirm that the products and equipment being used in a lab are not contaminated with microorganisms. It is also possible to conduct some basic testing in the field without having to send samples to a lab.
The microbiological testing helps to review microbiological contaminants in the finished doasge forms and also the factors that causes contamination of products.This testing is usually done to maintain sterility and to provide th customers with safe products.
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Batch Productions
Batch production is a technique used in manufacturing, in which the object in question is created stage by stage over a series of workstations, and different batches of products are made. There are several advantages of batch production- it can reduce initial capital outlay which is the cost of setting up the machines because a single production line can be used to produce several products. It is the most common process in pharmaceutical industry.
Batch production is a continuous process and promises efficiency as it is well controlled and flexible process.It is characterized by high labor costs,excess inventory leading to high production costs.
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Bulk Productions
A bulk drug production deals with the bulk drugs that are also called active pharmaceutical ingredient (API) is the chemical molecule in a pharmaceutical product (medicines we buy from the chemist) that lends the product the claimed therapeutic effect. It is termed as the production of pharmaceutical products in large volume on assembly units.
Bulk production of pharmaceuticals helps to achieve good productivity and improves the economic position of an pharmaceutical industry. It is a less time consuming process.
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Raw Material Testing
Raw materials testing ensure that the raw materials used in pharmaceutical products are suitable for their intended use. Conducting raw materials testing using appropriate test methods and successfully meeting the challenges of such testing can prevent costly production problems and delays.
Raw material testing includes evaluation and screening of fedstocks, unprocessed materials, semi-processed materials for quality specifications.It includes high range of analytical testing.
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Laboratory Records
Laboratory records are the set of record that constitute of written statements of overall intentions and directions as defined or given by the organisation or management. Laboratory records contain the entire information from the stage of receiving a raw material to manufacturing of a pharmaceutical dosage form.
Laboratory records are in turn classified into several types of records like batch records, master batch record, batch manufacturing records etc.
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Computerised Drug Processing
Computer drug processing is being used in increasing numbers in the pharmaceutical industry. Computer systems are used in a wide variety of ways in a pharmaceutical establishment, such as, maintenance of quarantine systems for drug components, control of significant steps in manufacturing the dosage form, control of laboratory functions, management of warehousing and distribution activities.
Computer drug processing systems may control one or more of these phases, either singly or as part of a highly automated integrated complex.
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