Why We Have to Learn This Subject gmp

8/13/2019 Why We Have to Learn This Subject gmp

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Why we have to learn this subject?

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygieneof staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. Theremust be systems to provide documented proof that correct procedures are consistently followed at each step in themanufacturing process - every time a product is made. - See more at: http://www.ispe.org/gmp-resources#sthash.4XQ51TIO.dpuf

Why we have always update our knowledge on GMP?

To encourage the early adoption of new technological advances by the pharmaceutical industry

To facilitate industry application of modern quality management techniques, including implementation ofquality systems approaches, to all aspects of pharmaceutical production and quality assurance

To encourage implementation of risk-based approaches that focus both industry and Agency attention oncritical areas

To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceuticalscience

How to apply it on Industry?

Why is GMP important?

Poor quality medicines are not only a health hazard, but a waste of money for both governments and

individual consumers.Poor quality medicines can damage health

A poor quality medicine may contain toxic substances that have been unintentionally added.

A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic

effect.GMP helps boost pharmaceutical export opportunities

Most countries will only accept import and sale of medicines that have been manufactured to

internationally recognized GMP. Governments seeking to promote their countries' export ofpharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by

training their inspectors in GMP requirements.What is GMP?

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced

and controlled according to quality standards. It is designed to minimize the risks involved in any

pharmaceutical production that cannot be eliminated through testing the final product. The main risks

are: unexpected contamination of products, causing damage to health or even death; incorrect labels on

containers, which could mean that patients receive the wrong medicine; insufficient or too much active

ingredient, resulting in ineffective treatment or adverse effects. GMP covers all aspects of production;

from the starting materials, premises and equipment to the training and personal hygiene of staff.

Detailed, written procedures are essential for each process that could affect the quality of the finishedproduct. There must be systems to provide documented proof that correct procedures are consistently

followed at each step in the manufacturing process - every time a product is made. WHO has

established detailed guidelines for good manufacturing practice. Many countries have formulated their

own requirements for GMP based on WHO GMP. Others have harmonized their requirements, for

example in the Association of South-East Asian Nations (ASEAN), in the European Union and through

the Pharmaceutical Inspection Convention.Is GMP necessary if there is a quality control laboratory?


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Yes. Good quality must be built in during the manufacturing process; it cannot be tested into the

product afterwards. GMP prevents errors that cannot be eliminated through quality control of the

finished product. Without GMP it is impossible to be sure that every unit of a medicine is of the same

quality as the units of medicine tested in the laboratory.Can manufacturers afford to implement GMP?

Yes. Making poor quality products does not save money. In the long run, it is more expensive findingmistakes after they have been made than preventing them in the first place. GMP is designed to ensure

that mistakes do not occur. Implementation of GMP is an investment in good quality medicines. This

will improve the health of the individual patient and the community, as well as benefiting the

pharmaceutical industry and health professionals. Making and distributing poor quality medicines

leads to loss of credibility for everyone: both public and private health care and the manufacturer.


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Commissioning

Commissioning is a well planned, documented, and managed engineering approach to the

start-up and turnover of facilities, systems, and equipment to the End-User that results in a safe and

functional environment that meets established design requirements and stakeholder expectations.i

That is, Commissioning verifies what was specified was installed, that it functions properly, and it

was successfully turned over to the user and reasonably ensures the next step verification for

regulated industries will be successful.

Given this definition, engineers have always commissioned projects to a degree. For

example, when a new pump is installed, the proper rotation and flow rate is verified. Before it is

installed, the model number and materials of construction are confirmed. Another example is an

HVAC system. The airhandler is confirmed to be leveled and adjusted. The controls are tested.

At the end, a test and balance contractor adjusts circuit setters for proper water flowrates, and to adjust

dampers for proper airflow. At the end of a project, the operators and maintenance staff are

trained. To have a record of what was installed, as-built drawings and Operations and

Maintenance manuals are developed. This is commissioning

Qualification

Qualification: A documented testing that demonstrates with a high degree of assurance that a specific

process will meet its pre-determined acceptance criteria. Validation: A documented testing, performed

under highly controlled conditions, which demonstrates a process consistently produces a result

meeting pre- determined acceptance criteria While qualification is used to provide a high degree of

assurance that a process is replicable under anticipated variable ranges, validation is used to describe

how a system will perform under highly controlled conditions. Based on the definitions above, it is easy

to see how these definitions are interchanged. However, the key difference is determined by whether or

not the process under review operates under 'highly controlled'

A design verification verifies that a frozen (static) design meets top level product

specifications.

A process validation validates that the on-going (dynamic) manufacturing process

produces product that meets product/print specifications and consist of installation


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qualifications, operational qualifications, process performance qualifications, a product

performance qualification and perhaps process verifications.

An installation qualification qualifies that equipment was installed correctly and are a

subset of a process validation (or possibly a test method validation).

Validation Examples:

Design validation, sterilization validation, test method validation, software

validation, and process validation.

Verification Examples:

Design verification and process verification.

Qualification Examples:

Installation qualification, operational qualification, process performance

qualification, product performance qualification, and supplied material qualification.


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Why is validation required?

Why Is Validation Required? 5, 6

O It would not be feasible to use the equipments without knowing whether it will produce theproduct we wanted or not.

O The pharmaceutical industry uses expensive materials, sophisticated facilities & equipments and

highly qualified personnel.

O The efficient use of these resources is necessary for the continued success of the industry. The cost

of product failures, rejects, reworks, and recalls, complaints are the significant parts of the total

production cost.

O Detailed study and control of the manufacturing process- validation is necessary if failure to be

reduced and productivity improved.

The pharmaceutical industries are concerned about validation because of the following reasons.

O Assurance of quality

O Cost reduction

O Government regulation

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Why We Have to Learn This Subject gmp