On October 18, 2021, the FDA published the 2021 Defects Summary Report on its official website, which summarizes the top 10 defects in the pharmaceutical field.
This article mainly on the defects of Article 5, 6, 10, combined with Capelliton products, and everyone to discuss.

Article 5 "Equipmentand utensils are not [cleaned] [maintained] [sanitized] at appropriateintervals to prevent [malfunctions] "Equipmentand utensils are not [cleaned] [maintained] [sanitized] at appropriateintervals to prevent [malfunctions] [contamination] that would alter thesafety, identity, strength, quality or purity of the drug product.
Failure to [clean][maintain][disinfect] equipment and appliances at appropriate intervals to prevent [failure][contamination] from altering the safety, identification, content, quality or purity of medicinal products. "
The quality and safety of drugs is related to the life safety and health of the people's livelihood, so the production environment of pharmaceutical enterprises has a particularly high cleanliness requirement. Regarding the cleaning of clean clothes, GMP Article 26 requirements: the cleaning and treatment of the work clothes used in the clean area should be able to ensure that it does not carry pollutants and will not pollute the clean area. The work clothes should be cleaned and sterilized in accordance with the relevant operating procedures. It is best to set up the laundry room separately.
The fabric of Garber clean suit is made of special polyester filament and conductive fiber, which are woven by special process. It has the characteristics of cleanliness, comfort, barrier, resistance to humidity and heat sterilization, durability and anti-static.

Garber clean clothes can be used repeatedly for 100 times. Generally speaking, clean clothes are usually washed 2-3 times a week, and high clean workshop requires one wash a day. The specific cleaning frequency has a direct relationship with the level it is used.

Capaliton independently developed special detergent for Capaliton clean clothes. It adopts innovative technology, phosphorus free, low bubble formula, and the main components are surfactants, water softener and PH regulator, which can effectively remove clothing stains, not damage the original fiber structure, protect its anti-static performance, and improve the comfort of clothing.

Article 6 "Appropriatecontrols are not exercised over computers or related systems to assure thatchanges in master production and control records or other records areinstituted only by authorized personnel.
Failure to exercise appropriate control over computers or associated systems to ensure that changes to master production and control records or other records are made only by authorized personnel. "
With the development and progress of pharmaceutical technology, GMP has put forward higher requirements for quality management in the process of drug production, including the requirements for access control system, such as "Article 44 Appropriate measures shall be taken to prevent the entry of unauthorized personnel. The production, storage and quality control area should not be used as a direct channel for people working outside the area." "Article 196 Access to production premises shall be restricted to approved personnel only."
In order to ensure the high quality of the pharmaceutical environment, it is necessary to strictly control the access and number of personnel in the clean area. However, the intelligent system management of pharmaceutical enterprises has not been popularized. At present, the personnel entry and exit control in most clean areas of pharmaceutical enterprises is mainly managed through the company system and the consciousness of employees. Manual management has many drawbacks, such as low efficiency, easy to make mistakes and difficult to query records.

The intelligent access control system independently developed by Capalito realizes the management of the access rights of personnel in the clean area, real-time control of the number of personnel in the clean area, query of personnel access records in the clean area, and the whole-life cycle management of the cleaning and sterilization status of the clean clothing through the RFID electronic tag built into the clean clothes. System background has a powerful data storage and record function, automatic generation of reports, truly realize the management of intelligent, information and data.

As a branch of the intelligent access control system, the cleaning and sterilization subsystem of clean clothing plays an important role in its powerful function. The system is composed of hardware and software. The hardware is composed of clean clothes and intelligent clean clothes management recorder with built-in RFID chip.
General pharmaceutical companies manually record the cleaning and sterilization information of clean clothing. The records are numerous and prone to errors, and there are uncontrollable risks, such as data falsification, ghostwriting and supplement, which will cause data deviation and ultimately affect the use effect.
The intelligent cleaning and sterilization management recorder of Capryton can monitor the cleaning and sterilization records of clean clothes in real time by scanning the RFID chip inside clean clothes, write the relevant information into the system database, and record the life and cleaning and sterilization status of clean clothes in real time, so as to achieve unified electronic and efficient management. The cleaning and sterilization of clean clothes are operated by authorized personnel. Before cleaning or sterilization, the operator's signature is required for verification, and the cleaning and sterilization can only be entered after passing.

Article 10 Employees arenot given training in [the particular operations they perform as part of theirfunction] [current good manufacturing practices] [written procedures requiredby current good manufacturing practice regulations].
Employees are not trained in [specific operations they perform as part of a function][CGMP][written procedures required by CGMP].
As we all know, human is the biggest source of pollution in the process of sterile drug production. In order to reduce human risk control, personnel training is crucial. The GMP and GMP Appendices for Sterile medicinal products also make relevant provisions.
Pharmaceutical Manufacturing Quality Management Practice (revised in 2010)
Article 27 All personnel related to drug production and quality shall undergo training, and the content of the training shall be appropriate to the post requirements. In addition to the theoretical and practical training of this code, there should also be relevant laws and regulations, responsibilities of corresponding posts, skills training, and regular evaluation of the actual effect of the training.
Article 29 All personnel shall receive training on hygiene requirements, and enterprises shall establish hygienic operation procedures for personnel to minimize the risk of pollution caused by personnel to drug production.
Quality Management Practice for Pharmaceutical Manufacturing (2010 revision) Appendix to sterile pharmaceutical products
Article 20 All personnel working in clean areas (including cleaners and equipment maintenance workers) shall be regularly trained to ensure that the operation of sterile drugs meets the requirements. The content of the training should include the basic knowledge of microbiology. Untrained external personnel (such as external construction personnel or maintenance personnel) should be given special detailed guidance and supervision when they need to enter the clean area during production.
Capperitone provides guidance on changing program configuration, free on-site aseptic changing process training, and video "Aseptic Changing Standard Operation Guidance". Regarding the intelligent access control system, Capellito provides guidance and training for the preliminary solution configuration, front-end hardware application, software function operation, hardware and software installation, daily maintenance, troubleshooting, etc.