Good Manufacturing Practices are essential for ensuring quality
Good Manufacturing Practices
(GMPs) constitute one of the core components that go into the
manufacture and distribution of foods, drugs and other pharmaceutical
products. Good Manufacturing Practices are prescribed by regulatory
agencies from around the world, the FDA and the EMA being among them.
The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.
The
FDA attaches the highest importance to quality, since drugs and
pharmaceuticals are consumed by millions of Americans for a variety of
diseases and conditions. Keeping this in mind, the FDA has formulated
guidelines with which manufacturing maintains set quality standards
across a range of products ranging from foods to pharmaceuticals. The
whole set of guidelines for manufacturing products in a variety of
industries and activities is clubbed under the collective term, “Good
Manufacturing Practices (GMP)”. The FDA attaches the highest importance
to quality, since drugs and pharmaceuticals are consumed by millions of
Americans for a variety of diseases and conditions. Keeping this in
mind, the FDA has formulated guidelines with which manufacturing
maintains set quality standards across a range of products ranging from
foods to pharmaceuticals. The whole set of guidelines for manufacturing
products in a variety of industries and activities is clubbed under the
collective term, “Good Manufacturing Practices (GMP)”.
Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.
No single set of standards
GMPs
and cGMPs are not a single, rigid and monolithic set of standards or
rules that everyone is expected to implement in their manufacturing
systems. The regulatory agencies prescribe a broad set of general
principles, from which a manufacturer from particular industries have to
implement at a minimum level of quality requirements, the ones
appropriate to it. Further, these guidelines offer options on the ways
by which those regulations that are relevant to it can be accomplished.
The organization needs to determine the one that suits it best for
implementing that system.
Purpose of Good Manufacturing Practices
Why
the regulatory agencies take this task upon themselves is because the
consumer is not in a position to identify a spurious product or one that
has not been through all these scientifically designated processes. The
fundamental purpose for which the regulatory agencies require adherence
to the CGMP regulations is that compliance to these guidelines is a
means to assuring the following:
In order to achieve this, drug manufacturers
have to take all the steps needed to control the manufacturing
operations. This includes establishing strong Quality Management
Systems, obtaining appropriate quality raw materials, establishing
robust operating procedures, detecting and investigating product quality
deviations, and maintaining reliable testing laboratories.
The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.
The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.
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Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.
No single set of standards
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Purpose of Good Manufacturing Practices
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The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.
Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:
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The GMP regulatory requirements in the EU
The EMA, being the regulatory agency for the EU; oversees the
implementation of cGMP guidelines. The EMA’s guidelines apply to all the
Member States of the European Union. The purpose for which these
guidelines are set out by the EU is more or less the same as that for
which other agencies such as the FDA lay out these rules. The essential
reason for which this is done is to ensure that the pharmaceutical or
any other regulated products:
The EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:
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- Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
- Directive 91/412/EEC, which relates to medicines for veterinary use
- Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.
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Labels: GMP Guidelines, good clinical practices, Good Laboratory Practices, Good Manufacturing Practices, pharmaceutical product guidelines, Pharmaceutical products
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