Understanding Good Manufacturing Practices (GMP) in Pharmaceuticals

Good manufacturing practices (GMPs) are an established set of guidelines that ensure consistent quality, safety, and efficacy of pharmaceutical products. GMP in pharmaceuticals encompasses several categories of the manufacturing process, including equipment, personnel, documentation, quality control practices, laboratories, and facilities. 

GMP guidelines should be implemented in the pharmaceutical sector as they help ensure public safety, allowing pharmaceutical companies to maintain pharmaceutical quality standards, meet customer expectations, and comply with regulatory requirements. This article discusses the key roles of good manufacturing practices in a pharmaceutical company.

What is the role of GMPs? 

GMPs have a three-fold role in the pharmaceutical industry.

Ensure product quality

GMP guidelines ensure that product quality is maintained throughout the manufacturing process. The guidelines help pharmaceutical companies avoid steps where the product may be contaminated. By following GMP in pharmaceutical manufacturing, companies can ensure they sell products with consistent quality.

Ensure product safety

GMP guidelines ensure product safety by avoiding or limiting instances where safety may be compromised. For example, personnel hygiene guidelines are created to ensure there is no cross-contamination between formulations. These guidelines also ensure there is minimal human interaction with the product. 

Ensure consistency

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Good manufacturing practices also regulate the use of facilities. For example, GMP regulations on facilities dictate how facilities should be arranged, which equipment should be ordered, and how everything should be maintained. By following these guidelines, companies can ensure their production process is efficient and consistent. 

By following GMP guidelines, pharmaceutical companies can ensure their final product meets the pharmaceutical quality standards. While GMP guidelines vary among regions, the basis of all GMP remains the same. 

Key GMP guidelines: Overview of major GMP guidelines.

Here are the key GMPs enforced across the world.

Quality management system

Under GMP guidelines, pharmaceutical companies need to implement a quality management system (QMS) that defines, validates, and controls all aspects of production. QMSs ensure all products are of the desired quality.

Standard operating procedures

GMP guidelines mandate the establishment and enforcement of standard operating procedures (SOPs). These SOPs include details of every step in the manufacturing process, from raw material procurement to packaging. SOPs aim to decrease the risk of errors during manufacturing.

Personnel guidelines

GMPs also include guidelines on personnel hygiene and training. These guidelines aim to decrease the risk of product contamination, ensuring higher product quality and safety. Personnel guidelines also include rules on the safety equipment (e.g., hazmat suits, gloves, safety goggles, and vests) for personnel.

Premises and equipment

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GMPs include specific guidelines on facilities, premises, and equipment used during manufacturing processes. The guidelines also provide detailed information about equipment maintenance, design, and cleaning. GMPs also include guidelines on how laboratories or manufacturing facilities should be set up to avoid cross-contamination.

Raw material control

GMPs also provide stringent guidelines to control the quality of raw materials companies can purchase. They include guidelines to test and verify all raw materials before their use. These guidelines ensure the original starting materials are of a certain standard, and only then can the final product be of the desired quality.

Quality control and testing

GMPs emphasize the importance of rigorously testing product quality at various stages during manufacturing, including raw material testing, in-process testing, and final product analysis. These ensure the final product will meet the quality requirements.

Process validation

All critical production processes are individually validated to ensure they meet certain criteria and afford products that meet pre-set standards. Validation involves rigorous testing of all steps to ensure they are reliable and reproducible.

In process controls

In-process controls are used to monitor and adjust processes as they run. This is done to detect real-time errors in the product or lapses in quality. Consequently, the error can be immediately corrected or an appropriate action to solve the quality lapse can be immediately taken.

Documentation

GMPs have stringent documentation requirements. According to GMPs, all aspects of production, all steps, materials/equipment used, and personnel need to be thoroughly documented. This is done to ensure the company can retrace errors and address any issues if they arise.

Continuous improvement

Under GMPs, pharmaceutical companies need to continuously improve all aspects of their processes. Companies are required to hold regular audits, reviews, and tests to ensure all aspects of the production process continuously meet the mark. 

Complaint and recalls

Companies also need to set up a system to handle customer complaints. They need to define appropriate teams that will handle complaints, look for the root cause of the problem, and solve the issue when necessary. They also need to define product recall protocols in case an entire batch or multiple batches need to be removed from the market within a short period.

Risk mitigation

Pharmaceutical companies also need to evaluate potential risks (safety, efficiency, efficacy, quality) and mitigate them. This get-ahead strategy aims to help pharmaceutical companies get ahead of any potential issues and develop solutions to resolve the problem.

Best practices for implementing GMPs

Here are some best practices for implementing GMPs in pharmaceutical manufacturing.

• Establish quality control protocols that check the quality of raw materials procured, in-process intermediates, and manufactured products.

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• Establish QMSs that define the roles of all employees and processes in the company.
• Maintain accurate records and SOPs of all aspects of production (from raw material procurement to sales).
• Create comprehensive training programs for all personnel, focusing on the importance of hygiene, safety, quality, and contamination.
• Design and maintain facilities according to appropriate guidelines, and see clarity from regulatory bodies when the guidelines are unclear.
• Regularly maintain and calibrate all equipment to ensure there are no equipment-related errors during manufacturing.
• Hold regular safety audits to identify hazards and potential risks. Once the risk is identified, develop appropriate solutions or protocols to handle hazardous incidents.
• Implement a formal process where any changes in the manufacturing process are documented. Furthermore, provide change access only to select and qualified personnel.
• Establish strict batch-release criteria using which employees check the product quality before the item is shipped.
• Hold regular training programs to upskill employees.

Conclusion

Good manufacturing practices are the pillars of pharmaceutical manufacturing. This article highlighted not only the importance of GMPs but also the 12 GMPs that are more prevalently used. We have also highlighted some best practices for implementing GMPs in pharmaceutical manufacturing. Implementation of GMPs varies from one company to another, but they are designed to help companies consistently provide products that meet safety and quality standards.

FAQs

1. Who enforces good manufacturing practices?

GMPs are enforced by different regulatory bodies in different countries. In the USA, GMPs are enforced by the Food and Drug Administration (FDA). In Europe, GMPs are enforced by the European Medicines Agency.

2. Are GMPs the same in all countries?

While the basic principles behind GMP guidelines in most countries are the same, specific requirements and guidelines vary between countries and regions.

3. What are the consequences of non-compliance with GMP guidelines?

Non-compliance with GMP guidelines may result in regulatory action such as product recalls, fines, or even shutdowns of manufacturing plants.