Current Good
Manufacturing Practices
(GMP/cGMP)
MANUFACTURING, TESTING,& QUALITY ASSURANCE GUIDELINES FOR NUTRACEUTICAL COMPANIES TO ADHERE TO INDUSTRY STANDARDS AND OBTAIN cGMP BOARD CERTIFICATION.
What is cGMP/GMP?
Current Good Manufacturing Practice (cGMP) is 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 production that cannot be eliminated through testing the final product. cGMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process.
There are five important principles of cGMP/GMP:
People | Premises | Processes | Products | Paperwork
Who Uses cGMP/GMP?
Industries
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Manufacture and sale of food and beverages
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Cosmetics
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Pharmaceutical products
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Nutraceuticals
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Medical devices
Entrepreneuers
Increase consumer confidence in your brand and your product by showcasing that you adhere to industry standards and federal regulations.
GMP vs. cGMP: The Difference
The “c” in cGMP stands for current which indicates that the most recent standards, technology, and methods are being applied to operations. The terms are largely interchangeable, with one major difference: The use of the term cGMP implies a commitment to the highest available standards of quality which is why it is important to make the distinction in a competitive and rapidly adapting market.
cGMP/GMP Benefits
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Increase continuous customer confidence
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Prove organization’s management capabilities in product quality, safety assurance
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Empower employees to develop superior workplace habits
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Ensure product quality, safety, and reduce risk
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Detect operational issues while reducing cost
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Develop a better comprehension with relevant laws and regulations
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Increase compliance
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Strengthen credibility and public perception
cGMP/GMP Principles
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Facilities must maintain a clean and hygienic manufacturing area
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Facilities must maintain controlled environmental conditions in order to prevent cross-contamination that may render the product unsafe for human consumption or use
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Manufacturing processes must be clearly defined and controlled
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All critical processes are validated to ensure consistency and compliance with specifications
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Manufacturing processes must be controlled, and any changes to the process must be evaluated
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Instructions and procedures must be written in clear and unambiguous language using good documentation practices.
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Operators must be trained to carry out and document procedures
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Records must be made, manually or electronically, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the product was as expected
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Deviations must be investigated and documented.
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Records of manufacture (including distribution) that enable the complete history of a batch to be traced must be retained in a comprehensible and accessible form
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Any distribution of products must minimize any risk to their quality
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A system must be in place for recalling any batch from sale or supply
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Complaints about marketed products must be examined, the causes of quality defects must be investigated, and appropriate measures must be taken with respect to the defective products and to prevent a recurrence
cGMP/GMP Resources
cGMP/GMP Industry Guidelines
