Are you not familiar with GMP? This article will guide you. GMP means Good Manufacturing Practice regulations, which the Food and Drug Administration promulgates in the US. With these regulations, the law mandated processors, manufacturers, and packagers of medical devices, drugs, some food, and blood take proactive steps to ensure that their products are effective, pure, and safe.
In addition, GMP regulations demand a quality approach for manufacturing. With this, companies can eliminate or reduce instances of mix-ups, contamination, and errors. It is essential so the consumer will not purchase dangerous or ineffective products.
What will happen if firms fail to comply with GMP regulations?
If firms fail to comply with GMP regulations, they may be subjected to serious consequences such as seizure, recall, jail time, and fines. GMP also addresses problems like personal qualifications, record-keeping, cleanliness, sanitation, process validation, equipment verification, and complaint handling.
Meanwhile, GMP is sometimes referred to as “cGMP,” wherein “c” means ‘current’ that reminds manufacturers to employ up-to-date systems and technologies to adhere to the regulation.
Why are GMP regulations important?
GMP focuses on manufacturing procedures to avoid possible risks like adulteration, mislabeling, and cross-contamination. FDA regulates cGMP and needs to be followed by companies.
Keep in mind that Good Manufacturing Practices are an essential system that needs to be implemented by all manufacturing facilities. Those who follow GMP standards can have assurance for their products’ quality, strength, and identity.
GMP regulations are important since they can reduce waste and facility losses. Additionally, it can protect consumers, companies, and the environment against harm. With these regulations, companies can earn more and keep the trust of consumers. Thus, it can convince consumers that their purchased products are made in well-regulated environments, safe, and adheres to government standards.
Factors in manufacturing practices for GMP
The following are factors to consider in GMP manufacturing practices:
Quality management focuses that the manufactured products perfectly suit their intended use. Companies should avoid expired, raw, and improper processes to prevent contamination or ham against harm.
Hygiene and sanitation
Hygiene and sanitation are crucial, especially for cosmetic, drug, and food manufacturers. It covers everything which can result to contamination.
The facility should also have clean equipment. The equipment should be located, designed, and maintained based on the correct procedures. Malfunctioning or defective equipment should be removed.
Location of facility
FDA also stated that manufacturing facilities need to be in a suitable location, away from contamination risks.
GMP also enforces that production materials need to be store properly. Additionally, there should be a proper inventory of the raw materials, including the source of materials for quality assurance.
GMP also ensures that facility personnel is qualified and well-trained.
Companies are required to have a GMP-compliant system and prepared solutions.
Qualification and validation
The steps of the manufacturing procedure need to have validation to adhere to GMP qualification guidelines.
Documentation and record-keeping
Documentation and record-keeping are also essential for GMP. The documents need to be in legible and clear ways.
Quality audits and inspections
With regular audits and inspections, facilities can comply with GMP properly.
To sum it up, adhering to GMP is essential to all companies for the safety of everyone.