Jim Thompson

Email Jim at jim.thompson@ipulpmedia.com

While many paper and paperboard products are used to package food, pharmaceuticals, and cosmetics (all products either ingested or applied to living beings), I seldom see GMP, or cGMP applied to their manufacture. I once worked at a facility where when we made a certain poor-quality board, we actually sold it to a local pizza chain for boxes that directly touched the product! Why? Because it wouldn't pass the test for a major food company.

If you are not familiar with GMP or cGMP, these are widely adopted standards originally developed by the bakery industry. They have been adopted and formalized by the FDA and the World Health Organization.

GMP is the acronym for Good Manufacturing Practices. cGMP is the acronym for Current Good Manufacturing Practices and is found in the regulations enforced by the Food and Drug Administration.

I know one major consumer products manufacturer that applies cGMP to everything they make, no matter the final use. Over many years, they have found following this protocol has made them very profitable.

There is such a thing as the Ten Golden Rules of cGMP. You can find them many places; I will repeat them here from Google:

1. Design and Maintain Facilities and Equipment:

Facilities should be designed for easy cleaning and maintenance, and equipment should be appropriate for the intended use and regularly maintained.

Adequate space and proper environmental controls (lighting, ventilation, temperature, humidity) are essential to prevent contamination.

2. Validate Processes:

Processes, including cleaning and production, should be validated through testing and documented to ensure they consistently produce the desired quality.

3. Write and Follow Procedures:

Standard Operating Procedures (SOPs) must be clear, concise, and followed meticulously.

All staff should be trained on relevant SOPs and understand their roles and responsibilities.

4. Document Everything:

Accurate and complete records are crucial for demonstrating compliance with GMP and enabling traceability.

Documentation should include batch records, quality control data, and any deviations or investigations.

5. Train and Develop Staff:

Personnel should be qualified and adequately trained to perform their duties effectively.

Training should be ongoing and updated to reflect changes in procedures or regulations.

6. Maintain Hygiene:

Good hygiene practices are essential to prevent contamination of products and materials.

This includes proper handwashing, personal protective equipment (PPE), and maintaining a clean work environment.

7. Control Materials and Components:

Incoming materials should be inspected and tested to ensure they meet quality standards.

Appropriate storage and handling procedures should be in place to prevent contamination or degradation.

8. Prevent Cross-Contamination and Mix-Ups:

Strict procedures and controls should be implemented to prevent cross-contamination between different products or batches.

This includes proper segregation of areas, equipment, and personnel.

9. Control Production and Process:

The manufacturing process should be monitored and controlled to ensure consistent product quality.

Deviations from established procedures should be investigated and documented.

10. Perform Audits:

Regular self-inspections and audits should be conducted to assess compliance with GMP and identify areas for improvement.

Audits should be documented and followed up with corrective actions.

If you really think about these items, it should be obvious to you that they will improve any manufacturing scenario and hence make it safer and more profitable, I don't care if you are making donuts, paperboard or mining coal.

Be safe and we will talk next week.

For a deeper dive, click here.

GMP Principles and Application Study Guide

I. Quiz

Instructions: Answer each question in 2-3 sentences.

1. What is the primary difference between GMP and cGMP, and which organization formally enforces cGMP?
2. Why does the author express concern about the sale of poor-quality board to a pizza chain for direct food contact?
3. According to the "Ten Golden Rules," what are two key considerations for the design and maintenance of facilities and equipment?
4. Explain the importance of "Validating Processes" in the context of cGMP.
5. What role do Standard Operating Procedures (SOPs) play in adhering to cGMP principles?
6. Why is comprehensive documentation considered crucial for cGMP compliance?
7. What does the "Maintain Hygiene" rule encompass to prevent product contamination?
8. How does the "Control Materials and Components" rule contribute to product quality and safety?
9. Describe the purpose of the "Prevent Cross-Contamination and Mix-Ups" rule.
10. What is the significance of conducting regular audits as per the cGMP Golden Rules?

II. Quiz Answer Key

1. GMP stands for Good Manufacturing Practices, while cGMP stands for Current Good Manufacturing Practices, reflecting the most up-to-date standards. The Food and Drug Administration (FDA) formally enforces cGMP regulations.
2. The author is concerned because the poor-quality board, which failed tests for a major food company, was sold for direct food contact in pizza boxes. This raises safety and quality concerns, as the material was deemed unsuitable for other food applications.
3. Facilities should be designed for easy cleaning and maintenance, and equipment must be appropriate for its intended use and regularly maintained. Adequate space and proper environmental controls like lighting, ventilation, temperature, and humidity are also essential.
4. Validating processes means thoroughly testing and documenting procedures, including cleaning and production, to ensure they consistently produce products of the desired quality. This provides assurance that the manufacturing steps are reliable and effective.
5. Standard Operating Procedures (SOPs) must be clear, concise, and followed meticulously by all staff. They ensure consistency in operations and help prevent errors, making them fundamental for maintaining quality and compliance.
6. Accurate and complete documentation is crucial for demonstrating compliance with GMP regulations and enabling traceability of products and processes. It includes batch records, quality control data, and records of any deviations or investigations.
7. The "Maintain Hygiene" rule includes practices such as proper handwashing, the use of personal protective equipment (PPE), and maintaining a clean work environment. These measures are essential to prevent contamination of products and materials.
8. The "Control Materials and Components" rule ensures that incoming materials are inspected and tested to meet quality standards. Appropriate storage and handling procedures are also put in place to prevent contamination or degradation of these materials, safeguarding the final product.
9. The "Prevent Cross-Contamination and Mix-Ups" rule requires strict procedures and controls to avoid contamination between different products or batches. This involves proper segregation of areas, equipment, and personnel to maintain product integrity.
10. Conducting regular self-inspections and audits is significant because it allows manufacturers to assess their compliance with cGMP and identify areas needing improvement. These audits should be documented and followed by corrective actions to continuously enhance quality and safety.

III. Essay Format Questions

• Discuss the broader implications of applying cGMP standards across various industries, even those not directly regulated by the FDA for cGMP, using examples from the text. How might this approach lead to both safer products and increased profitability?
• Select three of the "Ten Golden Rules of cGMP" and explain in detail how their rigorous application could significantly mitigate product recalls and consumer health risks in a manufacturing setting.
• Analyze the relationship between "Document Everything" and "Validate Processes" within the cGMP framework. How do these two rules mutually reinforce each other to ensure product quality and regulatory compliance?
• The author notes that cGMP standards were "originally developed by the bakery industry." Speculate on why an industry focused on baked goods might have been an early adopter of principles that later became fundamental to pharmaceutical and food safety.
• Imagine you are advising a paperboard manufacturing facility that wants to adopt the "Ten Golden Rules of cGMP" to improve its product quality and market reputation. Outline a strategic plan, focusing on at least five specific Golden Rules, detailing how the facility would implement each chosen rule and the anticipated benefits.

IV. Glossary of Key Terms

Audit: A systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives. In cGMP, this involves regular self-inspections to assess compliance.

cGMP (Current Good Manufacturing Practices): Regulations enforced by the Food and Drug Administration (FDA) that ensure products are consistently produced and controlled according to quality standards. It emphasizes the "current" aspect, meaning manufacturers must use technologies and systems that are up-to-date to comply with the regulations.

Cross-Contamination: The unintentional transfer of bacteria or other contaminants from one substance or object to another, with harmful effect. In manufacturing, this refers to the transfer of materials between different products or batches.

Documentation: Written records and procedures that provide evidence of compliance, product history, and manufacturing processes. It is crucial for traceability and demonstrating adherence to cGMP.

FDA (Food and Drug Administration): A federal agency of the United States Department of Health and Human Services, responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.

GMP (Good Manufacturing Practices): A system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

Personal Protective Equipment (PPE): Specialized clothing or equipment worn by employees for protection against health and safety hazards. In cGMP, it's essential for maintaining hygiene and preventing product contamination.

Standard Operating Procedures (SOPs): Detailed, written instructions that document a routine or repetitive activity. They are crucial in cGMP for ensuring consistency, quality, and compliance in all manufacturing processes.

Traceability: The ability to verify the history, location, or application of an item by means of recorded identification. In cGMP, robust documentation facilitates traceability of raw materials, processes, and finished products.

Validation: The documented act of proving that any procedure, process, equipment, material, activity, or system actually leads to the expected results. In cGMP, processes are validated to ensure they consistently produce the desired quality.

World Health Organization (WHO): A specialized agency of the United Nations responsible for international public health. WHO has adopted and formalized GMP standards internationally.

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