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 hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. 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. - See more at: http://www.ispe.org/gmpresources#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 of quality 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 on critical areas To ensure that regulatory review and inspection policies are based on state-of-the-art pharmaceutical science

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 of pharmaceuticals 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 finished product. 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?

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 finding mistakes 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.

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

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.

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 the product 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