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Good Manufacturing Practices (GMP) and Its Role in Quality Control

Good Manufacturing Practices (GMP) are guidelines for manufacturing processes and conditions that must be followed to ensure quality products. GMP covers all aspects of production from facility requirements and equipment to training and record keeping. The objectives of GMP and quality control are to minimize risks like contamination and mix-ups. Key requirements include validated processes, qualified personnel, adequate facilities, approved procedures, thorough record keeping, and quality testing of materials, batches and finished products.

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Tanvi Shah
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62 views

Good Manufacturing Practices (GMP) and Its Role in Quality Control

Good Manufacturing Practices (GMP) are guidelines for manufacturing processes and conditions that must be followed to ensure quality products. GMP covers all aspects of production from facility requirements and equipment to training and record keeping. The objectives of GMP and quality control are to minimize risks like contamination and mix-ups. Key requirements include validated processes, qualified personnel, adequate facilities, approved procedures, thorough record keeping, and quality testing of materials, batches and finished products.

Uploaded by

Tanvi Shah
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Good Manufacturing Practices

(GMP) and Its Role in Quality


Control
 Published on April 23, 2014
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Hassan Mostafa Technical Director and Project Director


FollowHassan Mostafa Technical Director and Project Director
Technical Director/PD at Breakanopharma Co.and QTDE + Managing Dir. for
QTDE Turnkey projects/training/qualification

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:

1. 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)

2. Production and control operations are clearly specified in a written


form and GMP requirements are adopted

3. Managerial responsibilities are clearly specified in job descriptions

4. Arrangements are made for the manufacture, supply and use of the
correct starting and packaging materials

5. All necessary controls on starting materials, intermediate products,


and bulk products and other in-process controls, calibrations, and
validations are carried out
6. The finished product is correctly processed and checked, according to
the defined procedures

7. 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

8. 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

9. Deviation/comp0lanin and recall s are reported, investigated and


recorded

10. There is a system for approving changes that may have an impact on
product quality

11. 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.

Under GMP:

1. 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
2. Critical steps of manufacturing processes and significant changes
to the process are validated;
3. 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
1. 4. Instructions and procedures are written in clear and
unambiguous language, specifically applicable to the facilities
provided
2. 5. Operators are trained to carry out procedures correctly
3. 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
4. Records covering manufacture and distribution, which enable the
complete tracing history of the batch, are retained in a
comprehensible and accessible form
5. Proper storage and distribution of the products minimizes any risk
to their quality are in place and documented
6. A system is available to recall any batch of product from sale or
supply

10. 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

11. 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

1. 12.

Quality Control
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:

1. 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;
2. samples of starting materials, packaging materials, intermediate
products, bulk products and finished products are taken by
personnel and by methods approved by Quality Control;
3. test methods are validated;
4. 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;
5. 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;
6. 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;
7. all batch of product are completely analyzed and approved in
accordance with the requirements of the relevant authorisations
8. 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.
https://www.fda.gov/drugs/developmentapprovalprocess/manufacturing/ucm124740.htm

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