Good Manufacturing Practices

Blogger: Mazen A. Majeed

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Good Manufacturing Practices

 

 

The main Purpose of GMP: To prevent harm to end users such as: Ensuring that the final products are non-contaminated, products are checked for quality and most importantly, the personnel must be well trained to check the products

 

 

 

Good Manufacturing Practice Guidelines

 

 

Manufacturing facilities must maintain a clean and hygienic manufacturing area and controlled environmental conditions to prevent cross-contamination

 

Manufacturing processes must be clearly defined and controlled. All critical process are validated to ensure consistency and compliance with specifications, and any changes in the process must be evaluated

 

Instructions and procedures should be written in clear and unambiguous language using good documentation practices, and operators should be trained to implement and document procedures

 

Records must be made, manually or electronically during manufacture that demonstrate that all the steps required by the defined procedures and instructions

 

Records of manufacture that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form

 

A system for recalling any batch from sales or supply

 

Customer complaints related to products must be examined such as: Product defects (smell, taste and color) must be investigated, and appropriate measures taken to prevent recurrence