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gmp(1).png - TripleMExpo

Method: Productivity improvement methods

GMP: Good Manufacturing Practices

 A good manufacturing practice (GMP) is one that conforms to the guidelines set by the regulatory agencies that control authorization and licensing for the production and sale of food, beverages and active pharmaceutical products .A product that conforms to GMP guidelines is considered to be of high quality and will pose no risk to consumers or the general public. The GMP guidelines do not lay out specific instructions for how to manufacturer a product; rather, they list general principles that must be observed during the manufacturing process. It is up to the individual manufacturer to decide how to set up its manufacturing system in order to best conform to the guidelines.

 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.

There are some basic manufacturing principles that every country's GMP guidelines include.

All guidelines follow a few basic principles:

Hygiene:

Pharmaceutical and Food manufacturing facility must maintain a clean and hygienic manufacturing area.

Systems and Processes:

Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications.

Any changes to the manufacturing process are evaluated. Changes that have an impact on the quality of the food product are validated as necessary.

Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices)

Operators are trained to carry out and document procedures.

Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the food product was as expected. Deviations are investigated and documented.

Records of manufacture (including distribution) that enable the complete history of a lot / batch to be traced are retained in a comprehensible and accessible form.

The distribution of the products minimizes any risk to their quality.

A proper product recall system is in place.

 Complaints about product from the market and consumers are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.

 GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company's responsibility to determine the most effective and efficient quality process.

 



  • Rose k
    Rose k

    Good Info!

    TripleMExpo