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Email: sales@wsk-sjz.com
Website:www.wsk-sjz.com
Address: No. 6, No.1 Road, Zanhuang County
Economic Development Zone Shijiazhuang,
Hebei 051230
Coenzyme Q10The formula ratios, homogenization processes, low-temperature emulsification parameters, and excipient compatibility of different dosage forms such as soft capsules, tablets, and powders, which contain two types of raw materials, oxidation and reduction, are all core commercial secrets of the OEM. The OEM factory has established a confidentiality system from seven dimensions: legal agreements, personnel classification, physical isolation in the workshop, digital control of formulas, full process production control, upstream and downstream supply chain, and waste disposal, to avoid the risk of formula and production process leakage in multiple ways, in line with the GMP production standards and industry compliance requirements for health products.
1、 Pre legal agreement constraints to strengthen the bottom line of cooperation confidentiality
At the beginning of the project negotiation, the factory and the brand partner signed a special NDA confidentiality agreement, clarifying the scope of confidentiality covering the amount of coenzyme Q10 added, the ratio of co solvents, the formula of soft capsule gel solution, the duration of homogenization temperature, the reduction process parameters, and sample testing data. The confidentiality period was agreed to continue for 3 to 8 years after the termination of the cooperation, and the compensation standards and accountability clauses for leakage were listed to lock in rights and responsibilities from the source of cooperation.
All business, R&D, and production management personnel involved in the docking project shall sign individual confidentiality commitment letters separately; Employees in classified positions shall sign confidentiality agreements and non compete agreements upon entry, stipulating that they shall not be allowed to work for similar coenzyme Q10 production enterprises within 2 to 3 years after leaving, and shall not copy or reproduce OEM formula processes without authorization. Before outsourcing equipment maintenance and third-party testing personnel enter the factory for operation, a temporary confidentiality agreement shall be signed uniformly, and the entire operation shall be accompanied and supervised by a dedicated person from the factory.
2、 Hierarchical management of personnel permissions
Following the control logic of "segmented decentralization and information fragmentation", no personnel in any position can gather complete information on the formula, raw material sources, and complete set of process parameters. The R&D department has complete formula ratios, but does not have access to workshop production equipment debugging parameters; The production operator only obtains a coded feeding list and does not know the true product names and addition ratios of the raw materials; The procurement personnel are unable to view the product compatibility plan while coordinating the supply of auxiliary materials; Quality inspectors control the standards for finished product testing and have no authority to access details of front-end production processes.
The factory regularly conducts confidentiality and legal education training, explicitly prohibiting employees from using personal software such as WeChat and QQ to transmit any coenzyme Q10 technical information. A system of accountability and punishment for leaks has been established, and any unauthorized copying behavior will be held accountable according to regulations. When employees resign, all paper materials, storage USB drives, and work equipment will be retrieved, and the IT department will immediately revoke all access permissions to the internal system and clear access permissions to confidential documents.
3、 Physical isolation of production area and establishment of enclosed and confidential workshops
For customized formulasCoenzyme Q10The product is designated as an independent and confidential production workshop, divided into ingredient area, homogeneous emulsification area, and soft capsule pressing area. Access control card swiping and facial recognition access system are deployed throughout the area, and external visitors and non project employees are strictly prohibited from entering without authorization. The entrance of the workshop is equipped with a unified mobile phone storage cabinet. During production operations, staff are not allowed to bring mobile phones or smart wearable devices into the production section to prevent the leakage of photos and videos on site.
The R&D sampling laboratory is independently controlled by zones, and the entire process of sample trial production is conducted in a closed manner. The remaining small samples are uniformly numbered and registered for retention, and are prohibited from being taken out of the laboratory without authorization; Conventional general production lines and confidential dedicated lines are separated by zones, and key parameters of equipment operation panels are hidden. Core temperature control, mixing speed, and other parameters are only authorized for supervisors to unlock and view.
4、 Digitalization and encryption control of formulas, blind production of raw material codes
All customized formulas of Coenzyme Q10 do not retain the original paper version. Electronic files are stored on a private encrypted server in the factory, using advanced encryption algorithms for storage. A multi-level key splitting mechanism is set up, and the retrieval of the complete formula requires the joint unlocking of technical, quality control, and production keys. The system automatically records each query log and retains records of the operator and query time for easy traceability.
The raw material coding system is implemented for production feeding, and the outer packaging of raw materials is only identified by internal codes, without labeling the true names of coenzyme Q10, various oils, and emulsifying agents. Operators blindly feed ingredients according to the coding documents, weigh and feed based solely on the coding, and cannot reverse derive the formula ratio based on the appearance of the materials; Different customers of the same Coenzyme Q10 product should stagger their production schedules to avoid cross leakage of multiple formulas.
5、 Control the entire production process and strictly prevent the leakage of process details
The key processes of coenzyme Q10 (low-temperature dissolution, nano homogenization, reduction modification, and soft capsule drying) are monitored and archived in high-definition throughout the entire process. The retention period of monitoring videos is not less than 6 months, and the factory's confidentiality department regularly retrieves and replays to verify the operational standards. The process operation manual is split and distributed, and operators only receive the corresponding section operation sheet, without a complete set of production process documents; Process parameter changes and formula adjustments require dual approval from the technical leader and the confidentiality management department, and the change files should be archived and sealed.
If customers need on-site production monitoring and regional observation, they are not allowed to extract parameters or collect raw material samples; If a sample needs to be sent for retention, it should be anonymously packaged without a brand, accompanied by a dedicated number registration ledger, and the flow of the sample and the information of the person handling it should be recorded throughout the process.
6、 Collaborative confidentiality of upstream and downstream supply chains, strict control of material leakage at the raw material end
Sign a supplementary confidentiality agreement with suppliers of coenzyme Q10 raw materials and auxiliary materials, which restricts the supplier from disclosing the supply category, purchase quantity, and product application formula to third parties; The brand can independently supply high activity coenzyme Q10 core raw materials, and the factory is only responsible for auxiliary material blending and finished product processing, isolating core ratio information from the source.
The packaging outsourcing manufacturer shall sign a confidentiality agreement simultaneously, and the outer packaging layout shall only indicate the general information of the finished product, without reflecting the internal formula composition and production process. The packaging scraps shall be uniformly recycled and destroyed to prevent the leakage of product information due to the outflow of outer packaging waste.
7、 Closed loop destruction of waste materials to eliminate potential risks of reverse cracking
Production residues, scrapped soft capsules, filter waste residue, expired trial products, and obsolete process documents shall be uniformly collected and entrusted to qualified third-party destruction institutions for crushing and melting disposal. Destruction images and signed ledgers shall be retained, and the outflow and resale of waste materials shall be prohibited to prevent peers from reverse analyzing waste materialsCoenzyme Q10Formula composition; The invalid paper formula files are shredded by a professional shredder, and the electronic waste data is deeply formatted and destroyed to prevent data from being recovered and stolen.
The factory conducts a special confidentiality internal audit every quarter to identify confidentiality vulnerabilities in workshops, systems, and warehouses, dynamically optimize confidentiality management systems, and continuously improve the security protection of the entire Coenzyme Q10 OEM chain.
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Email: sales@wsk-sjz.com
Address: No. 6, No.1 Road, Zanhuang County Economic Development Zone Shijiazhuang, Hebei 051230
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