Why are Good Manufacturing Practices (GMPs) important in the pharmaceutical industry?

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Most people are unaware of GMPs while pharmaceutical-grade concerns all consumers without exception. Good Manufacturing Practices (GMPs) for pharmaceutical products are the guideline that rules the regulatory standard to ensure pharmaceutical quality. 

What is the role of Good Manufacturing Practices (GMPs) standards in pharmaceutical product Quality Assurance?

In 2010, a subsidiary of GlaxoSmithKline (GSK), PLC paid $600 million to settle the False Claims Act. In other words, the company sold drugs that were significantly lower in quality than what was specified in documents submitted to the Food and Drug Administration (FDA). It was alleged that GlaxoSmithKline failed to ensure the drugs were free from contamination and had manufacturing defects that caused the tablets to split, rendering them ineffective.

 

Quality assurance in the pharmaceutical industry

 

Quality Assurance (QA) is a broad concept that covers all the most important aspects of the entire drug manufacturing process. It is a process performance and product quality monitoring system that helps companies protect their image and avoid penalties from regulators. But beyond that, it ensures that the prescribed drug produces the desired effect and ensures that the drugs comply with the regulations.

It should be noted that if a manufacturer fails to meet pharmaceutical grade standards, they may not only face hefty fines, but also possible legal actions that can jeopardize their business. This is why anyone involved in the manufacturing process must receive specific pharmaceutical training.

Pharmaceutical companies associate QA with the eight pillars of the Pharmaceutical Quality Systems (PQS) to provide high-quality finished pharmaceutical products. Those 8 pillars consist of: Auditing, QMS consultancy and design, GMP compliance, Training, Standard Operating Procedures (SOP) development, Qualified Person and Responsible Person provision, Inspection preparation and support, and Quality risk management. 

 

Origin of Good Manufacturing Practices (GMPs)

 

The WHO drafted the first text on good manufacturing practices (GMP) back in 1967 through a group of consultants following the request of the Twentieth World Health Assembly (resolution WHA20.34). It was subsequently accepted and entitled: “Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties”.

In 1969, in resolution WHA22.50, the World Health Assembly accepted the application of the WHO Certification Scheme on the quality of pharmaceutical products placed in international commerce. The GMP text was accordingly recognized as an integral part of the Scheme. In 1975, via the resolution WHA28.65, the scope of the Certification was extended to include information related to safety and efficacy, starting materials for use in dosage forms, etc.

In 1992, the revised draft requirements for GMP were presented.  The text guided actions to be taken separately by production and by quality control personnel for the implementation of the general principles of quality assurance (QA). Including topics such as hygiene, validation, self-inspection, personnel, premises, equipment, materials, and documentation. Production and quality control practices were subsequently integrated into the GMP for pharmaceutical products.

Considerable developments in GMP have taken place in the intervening years, and important national and international documents, including new revisions, have appeared.

 

What are Good Manufacturing Practices (GMPs)?

 

According to the World Health Organization, good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. 

Good Manufacturing Practices (GMP) is a compilation of various guidelines, guidance documents, directives issued and developed by international organizations and institutions, in collaboration with the pharmaceutical industry and several national regulatory authorities in different regions and countries, to ensure the highest standards of efficiency, quality and safety in any process involving the manufacture of pharmaceutical products. Most countries have legislated for manufacturers to follow GMP procedures.

It is a system that consists of processes, procedures, and documentation that ensures manufacturing products are consistently produced and controlled according to the set of quality standards. guidelines guide manufacturing, testing, and quality assurance to ensure that a manufactured product is safe for human consumption or use. 

GMP guarantees pharmaceutical manufacturers’ reputation, reduces risk, helps companies save money (batch recall, lawsuit compensations, fines, etc.), and create a competitive edge in an increasingly crowded and competitive marketplace. 

An important distinction to mention is that between good manufacturing practices (GMP) and current good manufacturing practices (cGMP). Usually interchangeable, GMP is the basic regulation published by the Food and Drug Administration (FDA) under the authority of the Federal Food, Drug, and Cosmetic Act to ensure that manufacturers take all necessary measures to ensure that their products are safe and effective. cGMP, on the other hand, has been implemented by the FDA to ensure continuous improvement in manufacturers' approach to product quality (constant commitment to the highest quality standards, use of new systems and technologies, …)

 

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The Good Manufacturing Practices (GMPs) contents

 

Good Manufacturing Practices (GMP) focuses on five key elements, often referred to as the 5 Ps of GMP to ensure that organizations comply with strict standards throughout the entire production process.

The 5 Pillars of Good Manufacturing Practices are:

 

People (GMP Training)

 

All manufacturing facilities must strictly adhere to GMPs and all employees must strictly follow manufacturing processes and regulations. This cannot be done without proper GMP training because providing compliance training to staff is the best way to ensure compliance with GMP standards. All employees involved in the drug manufacturing process must undergo GMP training to fully understand their roles and responsibilities. In addition, their performance must be evaluated as well as the training methods which must be continuously reviewed so that the manufacturer can ensure that its employees are well trained and competent.

 

Procedures

 

GMPs hold manufacturers accountable by requiring that procedures be documented and recorded. A procedure is a set of guidelines for undertaking critical processes such as pharmacovigilance, cold chain, batch recalls, etc. to achieve a consistent outcome. It must be presented to all employees, and training must be provided if necessary. Any form of deviation from the procedure must be analyzed and reported.

 

Products and Primary Materials

 

All products must undergo constant testing, comparison, and quality assurance before being released to consumers. Additionally, the raw materials used in the formulas must have precise specifications at each stage of manufacture, and there must be a record of the master formula. Standard methods should be followed for product packaging, testing, and sampling. Finally, test results must be recorded so that manufacturers are continually prepared for internal or external audits of their products.

 

Processes

 

It is part of the requirement that each process is clearly defined, correctly documented, consistent, distributed to all employees, and evaluated. Indeed, a regular evaluation must be carried out to ensure that all operations comply with current processes and meet the required standards. The manufacturer must have clear visibility of the operations. Compliance must be demonstrable by an auditor at any time and available for self-inspection to facilitate any possible improvement, as continuous improvement is a principle that drives GMPs.

 

Premises and equipment

 

In pharmaceutical manufacturing, premises include what lies beyond the walls of the facility. This is because there are regulations for the surrounding area to follow, including water systems and waste disposal. That being said, the premises involve all the infrastructure and systems around cleanliness to avoid cross-contamination, accidents, or even fatalities. All equipment should be placed or stored correctly and continuously validated and calibrated to ensure it is suitable to produce consistent results to prevent the risk of equipment failure. In addition, there must be clear procedures and documents for cleaning premises and equipment.

 

Consumers expect every batch of drugs they take to meet quality standards so that they are safe and effective. GMPs contain all the guidelines for organizations to meet this expectation throughout the manufacturing process. Today, there are new technologies for business operations that allow manufacturers to guarantee the public trust in the manufacturing quality of medicines. More and more organizations are relying on digital solutions to run their business, and that's the way to go if they want to compete in this industry in today's market.

 

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