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Definition of GMP (Good Manufacturing Practices) and cGMP (Current Good Manufacturing Practices)

Definition of GMP (Good Manufacturing Practices) and cGMP (Current Good Manufacturing Practices)

Definition of GMP:

Good manufacturing practices (GMP) means the practices required in order to ensure the guidelines recommended by authority  that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.

Definition of cGMP:

cGMP are the Current Good Manufacturing Practices which ensure that the products produced by pharmaceuticals company meet the specific requirements for identity, strength, quality, and purity of the product and followed by the pharmaceutical and biotech firms .

GMP is that part of Q.A (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 or Good Manufacturing Practices is aimed primarily at reducing the risks inherent in any pharmaceutical area or production.

Such types of  risks are essentially of two :

1. Cross-Contamination (in particular of unexpected contaminants)
2. Mix Ups (confusion) caused by, for example, false labels being put on containers

Under GMP:

(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;Holyworld CGMP

(c) All necessary resources are provided, including:
(i) Appropriately qualified and trained personnel;
(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;
(vii) Adequate personnel, laboratories and equipment for in-process Controls;

(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;
(g) Records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible 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;
(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.

Most of the renowned pharmaceuticals and biotech industry follow the CGMP guidelines beside Good laboratory practices and Good documentation practices.USA FDA authority control the GMP in all over the world to ensure the quality,purity,identity and standard of the product.Especially they control the food and drug industry.

Definition of GMP: Good manufacturing practices (GMP) means the practices required in order to ensure the guidelines recommended by authority  that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. Definition of cGMP: cGMP are the Current Good Manufacturing Practices which ensure that the products produced by pharmaceuticals company meet the specific requirements for identity, strength, quality, and purity of the product and followed by the pharmaceutical and biotech firms . GMP is that part of Q.A (Quality Assurance) which ensures that products are consistently produced and controlled to the quality standards appropriate to their…

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