Current good pharmaceutical manufacturing practices include all practices required to comply with the guidelines recommended by agencies authorizing and licensing drug product manufacturing and sale. These guidelines provide minimum requirements that pharmaceutical companies must meet to deliver high-quality products that pose no risk to consumers or the general public. Good Manufacturing Practices ( GMP) is that part of quality management which ensures products are manufactured and regulated according to quality standards. GMP regulates almost every aspect of a pharmaceutical company including hygiene and sanitation, premises, documentation, materials used, manufacturing and equipment. Have a look at QC Labels.
HYGIENE Or SANITATION:
In medicine manufacturing a high level of sanitation should be maintained. It involves cleaning of all the workers, buildings , machinery, and supplies and devices for development. Many of the Sanitation Instructions include:
(A) Before being employed, all personnel should undergo health checks to ensure that any materials or products are contaminated. During the period of employment the health tests should also be carried out regularly. Regular eye checks should be carried out for operators who conduct visual inspection.
- B) The staff should wear suitable clothing while they are in the factory. Clean body covering like hair coverings and masks should be used particularly in manufacturing areas.
- C) It is not allowed to consume, eat or display jewelry in manufacturing or storage areas to prevent pollution.
(D) Sterile clothes used in the manufacturing fields will be kept separately in closed bins from other cloths.
- E) Personal hygiene procedures should apply to all persons, including visitors, full-time or part-time employees, entering production areas.
The premises must be designed, located and built in such a way as to promote the production of quality pharmaceutical products. Including:
- A) The overall design and layout should minimize any risk of errors. In order to prevent cross contamination it should also encourage quick washing and maintenance. It should also ensure both people and materials flow logically.
- B) The production plant will be situated far from populated areas or other setting that may present a danger to the products or the finished product
(C) The premises should be well maintained, and any repair and construction should be carried out in a manner that does not affect the quality of the material or the product.
- D) The premises should be properly washed and desinfected in keeping with normal operating procedures.
- E) Provision of electricity and lighting should be sufficient and appropriate. Temperature and humidity should be controlled in such a way that they do not affect product quality directly or indirectly.
(F) The premises should be built in such a manner as to avoid the intrusion of rodents, birds or some other species.
(G) Restrooms and refreshment areas are to be located separately from the production areas.
- H) Storage facilities would provide ample storage space for both raw materials and finished items. They should also be dry, clean it well, and controlled temperature and humidity within acceptable limits. Highly addictive, narcotic, dangerous or toxic materials should be kept individually.
- I) A different region, such as penicillin or biological preparations such as micro-organisms, should be built for the processing of such critical items. Such products and other intensely active goods such as hormones can not be manufactured in the same plant as other normal items, including antibiotics and cytotoxics.