All about Good Manufacturing Practices (GMP) guidelines for pharmaceuticals Ensuring Quality in Manufacturing

Every industry prioritizes quality in its manufacturing practices. These practices require stringent safety protocols set out by GMP (Good Manufacturing Practices) guidelines. While many are familiar with GMP, let’s delve into some of its lesser-known facts.

The Birth of GMP: Why Was It Needed?

Behind every medicine, lies an extensive process. If the quality of medicine goes wrong, it questions not only its end product testing but also its manufacturing process and the entire chain of supporting elements. This realization gave birth to regulatory control, and there began the concept of GMP guidelines for pharmaceuticals.

Origins and Evolution of GMP

In 1938, the United States introduced the Food, Drug, and Cosmetic Act, which laid the foundation for regulatory control of GMP. However, it wasn’t until 1962 that the phrase ‘good manufacturing practice’ was formally coined under the Kefauver-Harris amendment. Since then, GMP has evolved, with the World Health Organization (WHO) adopting its first draft text in 1968.

Primary Aim of GMP

GMP is a significant part of the quality management system to ensure that products are consistently produced and controlled to meet quality standards appropriate for their intended use. This encompasses various areas:

Areas under GMP Guidelines

1. Quality management system (QMS)

QMS enables efficient control of the processes and procedures involved in the production of equipment. This system helps achieve good manufacturing practices by minimizing incidents of quality control related incidents.

2. Facilities and Equipment

The facilities must be equipped with solutions for specific manufacturing areas. Water equipment, HVAC with HEPA filters, and cleanroom systems must be duly qualified, installed, and maintained to prevent contamination and meet the GMP requirements of pharmaceuticals.

3. Sanitation and Hygiene

Undergoing regular cleaning and sanitization in our facilities to maintain a clean and hygienic manufacturing area for drug products. Practices such as personal hygiene and waste disposal also contribute to meeting the GMP guidelines.

4. Raw Materials

Raw materials and all components used in manufacturing require strict control, and proper handling to avoid any contamination and mix-ups.

5. Personnel

Personnel must be adequately trained to handle the working of the equipment and understand the importance of maintaining hygiene and cleanliness. Their jobs must be clearly defined and documented to achieve no lapses in responsibilities.

6. Packaging and Labelling

Packaging and labeling of pharmaceutical products must be of good quality to ensure product integrity and safety. The packaging process should be well controlled through proper validation, essential information, and accurate storage conditions along with a clear message on any warning/precaution.

7. Product Complaints and Recalls

Any complaint on product quality must be properly investigated and monitored to address the root cause and take corrective measures. A robust procedure must be in place to initiate and manage product recalls promptly to mitigate risks to consumers and comply with regulatory requirements.

8. Documentation and Recordkeeping

Comprehensive record-keeping practices document all aspects of manufacturing, testing, and distribution processes. This includes maintaining batch records, testing reports, production logs, and distribution records for an extended period to facilitate traceability, quality assurance, and regulatory inspections.

9. Validation and Qualification

All processes, systems, and equipment used in the manufacturing process must be validated to ensure that all function as per their intended use. It includes process validation, equipment IQ, OQ and PQ, cleaning method validation, analytical method validation, water system validation, and area qualification. All qualification and validation activities must be documented to demonstrate consistent performance of the process and system.

10. Inspections and GMP Audits

Conducting internal and external audits helps evaluate and identify the areas of improvement. Based on the findings, proper corrective actions must be followed to enable continuous improvement in the manufacturing process

Key Components of GMP: The 5 P’s of GMP

1. Products

The primary products including raw materials used in the manufacturing of equipment need to be of optimum quality. There must be no room for any deviation at every phase of the pharma production process. All products are required to undergo rigorous testing to ensure quality.

2. Processes

Processes should be well-documented and comprehensible. The same needs to be distributed to all employees. A regular evaluation of the process compliance must be conducted to ensure that all the required standards are being met.

3. Procedures

All the procedures to carry out critical processes must be laid out for the employees to achieve consistency. Any deviation in failing to follow the guidelines must be taken into account and duly looked into.

4. Premises

All laboratories and pharmaceutical manufacturing facilities and plants must be equipped with safety measures to achieve an effective working environment. There must be strict adherence to cleanliness to avoid cross-contamination and any accidents.

5. People

People must be thoroughly trained to adhere to the GMP quality standards. Training must be undertaken by all employees to understand and ensure their roles and responsibilities in the manufacturing process, enhancing further productivity and efficiency.

The Role of cGMP

The c of CGMP stands for ‘current’. This additional letter emphasizes the importance of maintaining continuous improvement through the adoption of up-to-date standards and technology. This adaptive approach is necessary to keep pace with the advancements in cleanliness methods and technology.

Difference between GMP and cGMP

• The difference between GMP and cGMP lies in their focus and currency. GMP provides general guidelines for manufacturing processes, while cGMP denotes the latest iteration of these standards.

• cGMP emphasizes the use of new technologies and stringent testing protocols, aligning with current advancements in pharmaceutical production.

• Regulatory agencies like the FDA and EMA regularly update GMP guidelines. Compliance with cGMP reflects adherence to the latest requirements, showing a commitment to staying current.

• While GMP evolves, cGMP highlights the need for manufacturers to keep pace with industry practices and technological advancements.

• GMP and cGMP ensure product quality, representing the latest standards. All in all, the terms are often used interchangeably as regulations evolve to maintain quality and safety.

Regulatory Oversight and International Standards

GMP and cGMP are regulated by various government agencies depending on the country or region. For example, in the United States, the Food and Drug Administration (FDA) oversees GMP and cGMP compliance through inspections and audits. International organizations like the World Health Organization (WHO) and the International Conference on Harmonization (ICH) provide guidelines for GMP on a global scale.

Non-compliance can result in regulatory actions such as warnings, fines, or product recalls.

Fabtech’s Commitment to GMP Compliance

At Fabtech, GMP Compliance is ingrained in our culture. We place paramount importance on quality and integrity in all our pharmaceutical engineering turnkey projects and endeavors. Our commitment extends across every facet of our work, ensuring that our products, processes, and solutions consistently meet and exceed GMP requirements.

Our dedication to upholding GMP standards remains unwavering, as we continuously strive for excellence and innovation in pharmaceutical engineering. Join us in setting the standard for excellence in pharmaceutical engineering. Contact us today to discuss your next pharmaceutical project.