Description

GMP guidelines and regulations require that manufacturers, processors, and packagers of drugs, medical devices, and food take proactive steps to ensure that their products are safe, pure, and effective. GMP guidelines and regulations address many issues that can influence the safety and quality of a product. Some of these are:

• Hygiene: Facilities must maintain a clean and hygienic manufacturing area.
• Controlled environmental conditions in order to prevent contamination and cross contamination.
• Manufacturing processes are clearly defined and controlled.
• Instructions and procedures are clear and unambiguous.
• Operators are trained to carry out and document procedures.
• Records are made either manually or by instruments during manufacture that demonstrate compliance with these guidelines and regulations.
• Records of manufacture (including distribution) enable the complete history of a batch to be traced are retained in a comprehensible and accessible form.
• The distribution of the products minimizes any risk to their quality.
• A system is available for recalling any batch of the product from sale or supply.
• Complaints are examined and investigated, and appropriate measures are taken with respect to the defective products and to prevent recurrence.