August 03, 2021
Definition, Difference, Audit Standards
1. What is GMP?
The full name of GMP is GOOD MANUFACTURING PRACTICE. The World Health Organization defines GMP as a regulation that guides the production and quality management of food, medicine, and medical products.
GMP is a set of mandatory standards applicable to pharmaceuticals, medical products, and food industries. It requires companies to meet hygienic quality requirements in accordance with relevant national laws and regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control. A set of operable work instructions helps companies improve their sanitary condition, identify issues in the production process in time, and make improvement. Briefly, GMP requires that pharmaceutical, medical products, and food manufacturing companies should have good production equipment, reasonable production processes, sound quality management and strict testing systems to ensure that the quality of the final product meets the legal requirements.
2. What is the difference between GMP and ISO9001?
GMP and ISO9001 are obviously different in nature, objects, implementation methods, and scope of application although they are both quality management standards.
ISO9001 is a recommended standard widely applicable to all walks of life whereas GMP is an enforced standard dedicated to pharmaceutical, medical products, and food industries. GMP requirements possess distinctive industry characteristics and specific practices.
ISO9001 is an international standard, but GMP is regional. Different countries and regions have established their own GMP standards and have different requirements.
3. What standards does GMP audit follow?
GMP audit are performed against GMP standards established by each country. In China, there are the following GMP regulations:
GMP audit are performed against GMP standards established by each country. In China, there are the following GMP regulations:
- Good Manufacturing Practices for Pharmaceutical Products
- Good Manufacturing Practices for Medical Device
- Measures for the Administration of Food Production Licensing
- Working Rules of Cosmetics Production Licensing
Taking the food industry as an example, audit is carried out according to the the General Principles for the Examination of Food Production Licenses as well as the On-site inspection and scoring record sheet for food and food additive production licenses which are supporting documents of the Measures for the Administration of Food Production Licensing.
4. Can GMP be applied to Consumer Products production?
With the continuous escalation of consumer demand for legal, safe, and high-quality products, more and more retailers and brands expect to introduce similar requirements of GMP into the consumer products manufacturing industry, so as to set a benchmark of good manufacturing practices for the manufacture of consumer products to protect product safety and consumer rights. Therefore, the application of GMP is no longer limited to traditional fields such as pharmaceuticals, medical products, and food. Similar requirements of GMP are being implemented in the consumer product manufacturing industry.
With the continuous escalation of consumer demand for legal, safe, and high-quality products, more and more retailers and brands expect to introduce similar requirements of GMP into the consumer products manufacturing industry, so as to set a benchmark of good manufacturing practices for the manufacture of consumer products to protect product safety and consumer rights. Therefore, the application of GMP is no longer limited to traditional fields such as pharmaceuticals, medical products, and food. Similar requirements of GMP are being implemented in the consumer product manufacturing industry.
However, unlike the pharmaceuticals, medical products, and food industries, in the consumer products manufacturing industry, there is no GMP regulation in each country or region, so no GMP standard is available for use; nor can the requirements in GMP standards of pharmaceuticals, medical products, and food be copied directly and completely.
5. What are the characteristics of SGS Kn-RBS's GMP audit for consumer products?
SGS Kn-RBS has designed a checklist of GMP audit for consumer products refer to the content of GMP standards for pharmaceuticals, medical products, and food, based on the approach of risk assessment. The main body of audit checklist includes 9 sections: (1) QMS and Testing, (2) HACCP and Recall, (3) Sanitation, (4) Worker Health & Hygiene, (5) Physical Plant & Equipment, (6) Maintenance, (7) Pest Control, (8) Operation Practices, and (9) Plant Security/Emergency Preparedness. The auditee is scored and rated by evaluating the conformity of each checkpoint and is encouraged to improve continuously.
SGS Kn-RBS has designed a checklist of GMP audit for consumer products refer to the content of GMP standards for pharmaceuticals, medical products, and food, based on the approach of risk assessment. The main body of audit checklist includes 9 sections: (1) QMS and Testing, (2) HACCP and Recall, (3) Sanitation, (4) Worker Health & Hygiene, (5) Physical Plant & Equipment, (6) Maintenance, (7) Pest Control, (8) Operation Practices, and (9) Plant Security/Emergency Preparedness. The auditee is scored and rated by evaluating the conformity of each checkpoint and is encouraged to improve continuously.
SGS Kn-RBS's GMP audit for consumer products is not a certification. After the audit, no certificate is issued, instead, an audit report is delivered to client or end buyer. Client or end buyer may make a “Pass or not” decision based on the overall score/grade of the report and identify opportunities for improvement according to the score/grade of each section as well as non-conformities. No validity period is set for the audit report, and end buyer may define it as per its purchasing strategy.
ENQUIRIES & REGISTRATION：
Ms Calla Huang
t: +86 (0)755 2532 8137
e: cn.rbs@sgs.com
About SGS
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