Category: Pharmaceutical

GOOD MANUFACTURING PRACTICE AND PHARMACEUTICALS

Some risks are usually associated with the production of pharmaceutical products; such risks are eliminated by setting quality standards. The quality standards set are what comprise the good manufacturing practice in the pharmaceutical industry. GMP ensures the pharmaceutical products including and cosmetics are efficient, safe, and of high quality.

GMP ensures daily regulations such as personnel qualification and training, sanitation and cleanliness, record keeping, and validation of the whole process. Pharmaceutical manufactures can decide on how they are going to implement these regulations. They are made open for flexibility purposes.

GMP is also sometimes referred to as current good manufacturing practice (cGMP) meaning there is a responsibility of a manufacturer to ensure that the quality standards are updated with the current technology so that they comply with current regulations. They also ensure they update their tools and equipment because there is constant improvement in their technology. Tools and equipment are most useful in ensuring quality standards are met. In pharmaceutical manufacturers, should follow the five principles to ensure quality standards are met during the manufacturing processes.

RAW MATERIALS AND PRODUCT

This is one of the most important points, in pharmaceutical production but most importantly at this point, it is where most of the production problems start. Raw materials are necessary since they are the ones used in the production of the end product. Raw materials should be properly be inspected and assessed before they can enter the production unit. The quality of the end product entirely depends upon the raw materials selected. Choose a poor quality raw material and expect production of a low-quality final product. After selecting a good quality raw material, the final product needs to be reassessed by removing the defective product. Additional testing should be done in a laboratory to check the presence of a chemical, physical or biological hazard.

FACILITY AND EQUIPMENT

In the pharmaceutical industry, tools and equipment are used in testing the quality of the product formed. The pharmaceutical industry can sometimes overuse equipment to avoid the cost associated with replacement and updating equipment. They end up using outdated or faulty equipment, such tools, and equipment greatly influence the quality of the final product. Broken tools and equipment should be replaced or updated when needed to run the operations smoothly and efficiently which results in a production of a quality product.

STAFF

Apart from having functioning and updated tools and equipment, it is people who implement these principles. Staff should be trained on the importance of GMP including practices such as cleanliness and hygiene from a personal level to the working environments. The training the employees undergo should be reassessed on daily basis to ensure important areas are covered and are up to date.

PRODUCTION GUIDELINES

There has to be documented clear instructions on the procedures to be followed during the manufacturing process. Such guidelines and procedures should be up to date with the current technology.

GUIDELINES VALIDATION

The procedures have to be a document that proves that the above procedures are followed throughout the manufacturing processes, that is from material inspection to the packaging and testing of the final product.