Why GMP Audits are a Necessity?

GMP Audits

Talking of product safety, the goods that require maximum scrutiny are health, food and beauty products. To make sure that the suppliers and manufacturers belonging to this sector are maintaining the standards set by government agencies, GMP audits are necessary. It’s important to ensure that the manufacturing process is well defined and controlled and the product matches the predefined specifications. In case alterations in the procedures affect the product, there must be appropriate procedure for analyzing the product for its quality. And, if the quality gets compromised, the product must be discarded. Customers should receive the product with clear and understandable instructions. GMP audits ensure that all the procedures in the supply and manufacturing units are in accordance with the recommended practices and the products meet the quality specifications.

GMP

GMP is an acronym for Good Manufacturing Practices and refers to a set of practices required to maintain the quality and safety of food, pharmaceuticals and cosmetic products. GMP audits are compliance audits that verify the working conditions. They ensure that an organization is following the rules and regulations and producing products that meet the quality requirements.

GMP Guidelines

The two most common standards for GMP guidelines have been issued by the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA). GMP guidelines that have been drafted by WHO are more focused on medicinal products and are applied mostly to the pharmaceutical industry. GMP guidelines issued by the FDA encompass a wider range of industries including food, medical devices, prescription drugs and cosmetics. These guidelines are known as current good manufacturing practices (cGMP) and include methods, facilities, controls, equipment, packaging and labeling required for manufacturing and importing a product.

Although GMP guidelines vary with different versions, the core objective remains the same. Certain basic principles from the GMP guidelines issued by WHO include:

• All the manufacturing processes must be well-defined and should be capable of producing products for intended use
• Qualification and validation should be performed
• All necessary resources must be provided
• Procedures and instructions should be written in clear and understandable manner
• Procedures must be carried our correctly and workers involved must be properly trained
• Records should be made and maintained for all the procedures
• Records must cover manufacturing as well as distribution to demonstrate the entire history.
• Storage and distribution should be proper for minimizing risk to the quality
• A system must be available to recall any batch of product from supply or sale
• Complaints must be investigated and issues must be resolved

Every product requires certain precautions during the manufacture. GMP audit is one such precaution to make sure that the products meet certain standards and maintain a consistent quality across an industry. GMP audits protect consumers from any kind of harm from health, food or beauty products.