Week of 14 July 2025: Housekeeping: GMP, cGMP and the 10 Golden Rules
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:
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.
Processes, including cleaning and production, should be validated through testing and documented to ensure they consistently produce the desired quality.
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.
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.
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.
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.
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.
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.
The manufacturing process should be monitored and controlled to ensure consistent product quality. Deviations from established procedures should be investigated and documented.
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.
II. Quiz Answer Key
III. Essay Format Questions
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. ________ Other interesting stories:
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