Good Manufacturing Practices are a number of practical and basic procedures of obligatory use in where it receives, fractionate, processed or packaged products in order to produce a safe product. With the implementation of the GMP it generates barriers to prevent risks. The existing risks are essentially of two types: pollution (particularly unexpected contaminants) and mixtures (confusion). The contamination of products can be avoided with an integrated plague management, the implementation of SOP's program (standard operating procedure for healthcare) cleaning and disinfection of equipment and surfaces. Care of personal hygiene and health, use fingernails short, clean and unpolished, the ban on the use of personal items, a proper hand washing before the elaboration, after using the toilet and after each interruption, the use of appropriated and exclusive clothes for the processing of food, collected hair and use a cap. The control of cross-contamination at the moment of food handling and storage. The registration and verification of all aspects are vitally important to identify potential risks and take corrective actions.  

Requirements of the standards

 

Teams must be qualified and the processes validated.

  1. Have the necessary resources for the proper development of medicines.
  2. Procedures (SOP) would be draft in a clear and unambiguous language, and a specifically applicable to the means of production available.
  3. Keep record (manually or electronically way) during manufacture, to show that all the operations required by the defined procedures have been actually carried out, and that the quantity and quality of the product are provided. Any significant deviation must be recorded and thoroughly investigated.
  4. The records relating to the manufacture and distribution, which provide insight into the complete history of a batch, be maintained so they could be complete and accessible.
  5. The storage and distribution of products must be adequate to minimize any risk of quality diminished.
  6. Establish a system that allows removing any product, whether at the stage of distribution or sale.
  7. Study any claim against a product already marketed and, also, investigated the causes of quality defects and take appropriate measures action with respect to defective products to prevent defects recurring.


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