Business Field
Pharmaceutical, biotechnology, tissue culture and medical device industries
The pharmaceutical industry is based on Good Manufacturing Practice (GMP); GMP is not only applied in the pharmaceutical industry, but also in food, cosmetics, etc., but not to the same extent as in the pharmaceutical industry. GMP regulations are the way it should be applied in the pharmaceutical industry, but they have become a legal standard with added legal enforcement. Regulations differ slightly from country to country, but the ultimate goal is the same: to guarantee the efficacy and safety of the products produced, and to have a consistent production control policy to ensure product quality on a permanent basis. This will ensure that the medicines supplied are safe for consumers and give them a quality they can trust.
GMP is necessary to achieve this objective. In the United States, GMP is defined as ensuring safety (S), Identity (I), Strength (S), purity (P), and quality (Q) in processing, manufacturing, packaging, and storage processes. In Japan, the three principles of GMP also state (1) prevention of cross-contamination, (2) prevention of human error, and (3) advanced quality assurance system.
Good Manufacturing Practice (GMP) originated in the United States in the 1960s and is now a globally recognized term for the management and control of all aspects of food and pharmaceutical manufacturing, testing, and quality control. Good Manufacturing Practice (GMP) is a system for ensuring that products are manufactured according to a quality system established to maintain product quality on a consistent basis and to ensure that the expected quality is achieved. For example, in order to prevent cross-contamination, it is essential to determine a procedure to completely wash the previous product to prevent contamination from outside as well as contamination from other products, and to verify the effectiveness of this procedure (cleaning validation). It is also necessary to plan the flow of people and goods so that workers do not bring in other products. Thus, a quality assurance system must refer not only to the operation of manufacturing operations, but also to the design of equipment and facilities.
Prevention of human error refers to the misreading of similar labels, which can result in a recall if a product is mislabeled. Quality assurance measures, such as changing labels to make them less prone to errors, avoiding the production of products with similar labels on nearby lines, and educating workers, require both software measures, such as operations and regulations, and hardware measures, such as layout and partitions between packaging lines. In addition, clear procedures (Standard Operating Procedures: SOPs) must be established to prevent mistakes, and education and training must be provided to ensure that all employees are familiar with these procedures. All implementation and verification work must be recorded, stored, and guaranteed. This documentation system is also a must.
PT CCI, as a member of the CM Plus group, is an organization that is dedicated to supporting GMP implementation and provides optimal solutions in terms of both software and hardware required for GMP for clients seeking compliance with international GMP standards such as EU-GMP, PIC/S, cGMP, J-GMP, WHO-GMP, and FDA cGMP. We offer professional services that provide optimal solutions in terms of both software and hardware required for GMP. We also provide professional services to implement the latest and best GMP practices, including the provision of paperless validation systems to maintain and improve quality in the pharmaceutical industry, which is becoming increasingly high-tech.
Food, Flavoring, Detergent, and Plant-based industries
The food industry must consider “food safety. Producing unsafe food can lead to foodborne illness, product recalls, lengthy and costly legal/court cases, and unintentional loss of public trust. As part of global business, customers demand assurance that food is processed according to food safety standards from farm to table in the food chain.
Good Manufacturing Practices (GMPs) are systems that contain minimum requirements that the food and packaging industry must meet as they relate to food safety, quality, and legal requirements. Common standards include Title 21 Code of Federal Regulation (CFR) part 110 “Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food” and “General Principles Food Hygiene, WHO/FAO International Code Practice.” This standard is commonly applied in the food and packaging industry, and the effective implementation of system management that applies the concepts of Hygiene & Sanitation to Good Manufacturing Practices / GMP systems can bring trust and benefit to the food industry and related packaging and related packaging industries.
As a specialized consultant to the food industry, CM Plus is experienced enough to handle complex manufacturing processes such as We provide one-stop services for design and production facilities (operations management), quality assurance, storage, pest control, worker hygiene, maintenance, flushing and cleaning, waste management and facility validation management (protocol development and implementation record keeping) including process equipment, GMP training, and much more.
Cosmetic Industry
While GMP for pharmaceuticals states the efficacy and safety of drugs, GMP for cosmetics requires only safety. The purpose of GMP for cosmetics is to ensure the safety of cosmetics by ensuring the same quality in processing, manufacturing, packaging, and storage as in the manufacture of pharmaceuticals.
In the U.S., for example, if a sun protection factor (SPF) claim is made for a sunscreen cream or lotion, it is treated like an OTC (over-the-counter drug) and is subject to the same FDA inspections as a drug. Although a different approach is required than for pharmaceuticals and medical devices, the same requirements apply: sufficient accountability is required during inspections.
Each company is responsible for assuring the safe quality of its products. This need is related to the various regulations governing the sale of cosmetics. For example, in the United States, the Federal Food, Drug, and Cosmetic Act (Section 301), enacted by the FDA, prohibits the sale of “counterfeit” or “misbranded” cosmetic products. In Canada, the Food and Drugs Act (Articles 16 and 18) requires that cosmetics for sale must be manufactured and stored in a clean and sanitary environment.
In some countries, GMP for cosmetics is supported and strongly recommended by national authorities, but is not mandatory. In the United States, GMP is required of cosmetic businesses but is listed as a guideline. Similarly, in Canada, cosmetic businesses are encouraged by Health Canada to follow GMPs as defined in the ISO 22716 standard.
In other regions, however, GMP is a legal requirement for cosmetics manufacturers. In Europe, for example, the Cosmetics Regulation (EC) 1223/2009 requires cosmetics intended for sale on the EU market to comply with the cosmetics GMP guidelines outlined in ISO 22716.
Our engineering consultants, CM Plus, are well versed in these regulations and have extensive experience in facility design, validation, and QMS to assist you in the creation and operation of your facility. CCI is able to provide information of great importance to the cosmetics industry in ASEAN countries, especially in Indonesia. We have successfully completed several international scale factories in Indonesia.
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