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GMP

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by

Mawada Essam

on 21 April 2013

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Transcript of GMP

GOOD MANUFACTURE PRACTICE Definition of A good manufacturing practice (GMP) is :- Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. A production and testing practice that helps to ensure a quality product. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guideline. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing. all guidelines follow a few basic principles:- • Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specification • Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. • Instructions and procedures are written in clear and unambiguous language. • Operators are trained to carry out and document procedures. • Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. • Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. • The distribution of the drugs minimizes any risk to their quality. • A system is available for recalling any batch of drug from sale or supply. • Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements.

It is the company's responsibility to determine the most effective and efficient quality process. QSEM The ICH topics are divided into four categories and ICH topic codes are assigned according to these categories. Q Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Quality Guidelines:- S ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. Safety Guidelines:- E The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines. Efficacy Guidelines:- M Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI) Multidisciplinary Guidelines:- GMP for food industry We also have comprehensive list of international licenses including halal-certification. GMP has been servicing the health food industry since 1994. Our philosophy is to work harder for your success; this means we have the capacity to provide custom manufacturing solutions to a wide variety of specification. GMP's Auckland factory is the largest contract manufacturer in New Zealand, while our Australian plant services supermarket giants such as Woolworths. GMP is certified and licensed in both Australia and New Zealand to manufacture pharmaceuticals, dietary supplements, dairy products, restricted animal products, early childhood nutritional formulas and organic foods. Good manufacturing practices for pharmaceutical products (GMP) Good manufacturing practice is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization.

GMP are aimed primarily at diminishing the risks inherent in any pharmaceutical production. Such risks are essentially of two types cross contamination
(in particular of unexpected contaminants) mix-ups (confusion)
*caused by, for example: false labels being put on containers. WHO guidelines on good manufacturing practices (GMP)
for herbal medicines a. all manufacturing processes are clearly defined, systematically reviewed in the light of experience, and shown to be capable of consistently manufacturing pharmaceutical products of the required quality that comply with their specifications. b. qualification and validation are performed. c. all necessary resources are provided, including: (vii) adequate personnel,laboratories and equipment for in-process control. (ii) adequate premises and space; (iii) suitable equipment and services; (iv) appropriate materials,containers and labels ;(v) approved procedures and instructions. (vi) suitable storage and transport; (i) appropriately qualified and trained personnel; f. records are made (manually and/or by recording instruments) d. instructions and procedures are written in clear and unambiguous language, specifically applicable to the facilities provided. e. operators are trained to carry out procedures correctly. f. records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; any significant deviations are fully recorded and investigated; j. complaints about marketed products are examined, the causes of quality defects investigated, and appropriate measures taken in respect of the defective products to prevent recurrence g. records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprhensive and accessible form. h. the proper storage and distribution of the products minimizes any risk to their quality; i. a system is available to recall any batch of product from sale or supply;
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