GMP GMP (Good Manufacturing Practice) Question and Answers? (Discussion)
What is Good Manufacturing Practices(GMP)?
GMP (Good Manufacturing Practice) is part of a quality system covering the manufacture and testing of pharmaceutical dosage forms or drugs and active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products, and medical devices. GMPs are guidance that outlines the aspects of production and testing that can impact the quality of a product.
Quality Assurance / GMP Objectives
Quality Assurance is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Assurance therefore incorporates Good Manufacturing Practice .
The system of quality assurance appropriate to the manufacture of pharmaceutical products to ensure that:
>Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of good laboratory practice (GLP) and good clinical practice (GCP)
>Production and control operations are clearly speciﬁed in a written form and GMP requirements are adopted
>Managerial responsibilities are clearly speciﬁed in job descriptions
>Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials
>All necessary controls on starting materials, intermediate products, and bulk products and other in-process controls, calibrations, and validations are carried out
>The ﬁnished product is correctly processed and checked, according to the deﬁned procedures
>Pharmaceutical products are not sold or supplied before the authorized persons have certiﬁed that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control and release of pharmaceutical products
>Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed, and subsequently handled so that quality is maintained throughout their shelf-life
>Deviation/comp0lanin and recall s are reported, investigated and recorded
>There is a system for approving changes that may have an impact on product quality
>Regular evaluations of the quality of pharmaceutical products should be conducted with the objective of verifying the consistency of the process and ensuring its continuous improvement
What is GMP in Pharmaceutical Products:
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 is 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) and mix-ups (confusion) caused by, for example, false labels being put on containers.
Good Manufacturing Practice is concerned with both production and quality control.
>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
>Critical steps of manufacturing processes and significant changes to the process are validated;
All necessary facilities for GMP are provided, including
Appropriately qualiﬁed and trained personnel
Adequate premises and space
Suitable equipment and services
Appropriate materials, containers and labels
Approved procedures and instructions;
Suitable storage and transport;
Adequate personnel, laboratories and equipment for in-process controls
Instructions and procedures are written in clear and unambiguous language, speciﬁcally applicable to the facilities provided
Operators are trained to carry out procedures correctly
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
Records covering manufacture and distribution, which enable the complete tracing history of the batch, are retained in a comprehensible and accessible form
Proper storage and distribution of the products minimizes any risk to their quality are in place and documented
A system is available to recall any batch of product from sale or supply
>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
>no batch of product is released for sale or supply prior to certification by an authorised person that it is in accordance with the requirements of the relevant authorisations
is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.
The basic requirements of Quality control are that:
>Adequate facilities, trained personnel and approved procedures are available for sampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoring environmental conditions for GMP purposes;
>Samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control;
Test methods are validated;
>Records are made, manually and/or by recording instruments, which demonstrate that all the required sampling, inspecting and testing procedures were actually carried out. Any deviations are fully recorded and investigated;
>The finished products contain active ingredients complying with the qualitative and quantitative composition of the marketing authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled;
>Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assessed against specification. Product assessment includes a review and evaluation of relevant production documentation and an assessment of deviations from specified procedures;
>All batch of product are completely analyzed and approved in accordance with the requirements of the relevant authorization
>Sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in its final pack unless exceptionally large packs are produced.
Asst. Manager at NetZealous Services India Pvt Ltd