The concept of a pollution control strategy (CCS) was first introduced in Annex 1 of EU GMP, Production of Sterile Products, with personnel listed as one of the control elements.
Personnel pollution control includes personnel training, hygiene and behavior. Notes on behavior habits in the previous aseptic pollution control strategy, personnel norms key points (1) : behavior habits have been elaborated, this time on the content of personnel training to do discussion with you. Appendix 1 clearly puts forward personnel training, training content and evaluation standards in Chapter 7 "Personnel".

The importance of personnel training:
1. In the process of sterile drug production, the influence of personnel is the largest and most uncontrollable.
According to relevant data, pollution caused by personnel accounts for 80% of clean room pollution, production equipment and tools account for 15%, clean room itself and filter defects account for 5%.
2. Requirements of GMP and EU GMP Regulations:
(1) EU GMP Annex 1 Chapter 7 Requirements:
The manufacturer shall ensure that it has sufficient qualified personnel who are appropriately qualified, trained and experienced in the manufacture and testing of sterile products and in any of the specific manufacturing techniques used at the manufacturing site to ensure that the manufacture of sterile products meets the requirements of the pharmaceutical manufacturing quality management practice.

(2) 2010 edition of GMP Sterile drugs Appendix Basic requirements:
Article 20 All personnel working in clean areas (including cleaners and equipment maintenance workers) shall be regularly trained to make sterile drugs
The operation meets the requirements. The training should include basic knowledge of hygiene and microbiology. Untrained external personnel
(such as external construction personnel or maintenance personnel) should be specifically indicated when they need to enter the clean area during production
Guide and supervise.
Training for aseptic operators:
1. Good Manufacturing Practice (GMP)
2. Aseptic operation technology
3. Clean room code of conduct
4. Basic knowledge of microbiology
5. Basic knowledge of hygiene (concepts of cleaning, disinfection and sterilization, etc.)
6. Changing procedure, including all the details of the changing procedure
7. Contact sampling method
8. Pollution control
9. Harm to patient safety of drugs contaminated with microorganisms
10. Key process characteristics
11. The meaning of limits of vigilance and limits of action

Training content of aseptic process personnel simulation operation:
1. After dressing simulation training and verification, announce the list
2. Aseptic process simulation training of possible shutdown troubleshooting methods in aseptic production process
3. Simulation training of cleaning and asepsis of machinery and equipment in Grade A area
4, online cleaning, online sterilization, miscellaneous equipment cleaning, sterilization, removal, transport simulation training
5. All the operators in the aseptic area participated in the media simulation filling test
6, step by step training, not regular assessment
With regard to the scope of personnel, Appendix 1 is defined in chapter 7, Personnel. "All personnel working in the area, including those engaged in cleaning, maintenance, monitoring and other access to clean areas, shall receive regular training".
Evaluation criteria for personnel training:
1. "Personnel working in level A/B areas shall be trained in aseptic dressing and aseptic practices. Compliance with aseptic dressing procedures should be assessed and confirmed and should be periodically re-evaluated at least annually, including visual and microbiological assessments (monitoring sites such as hands, arms, chest and forehead, acceptable limits refer to 9.30).

Maximum microbial contamination

(a) The settling dish shall be sampled during operation and replaced as needed after four hours (exposure time shall be based on the included recovery rate
The time of exposure should not have any adverse effect on the suitability of the medium used). A single settling disc can explode
Dew less than 4 hours.
(b) It should be noted that for grade A, any growing bacteria will need to be investigated.
(c) Contact plate limits apply to Class AB equipment and clothing surfaces. Depending on the functionality of the CD-level area, it is generally not required
Monitor CD - level routine dressing operation.
2. Access to Level A/B clean areas for aseptic operations or aseptic operations to be performed should be restricted to appropriately qualified personnel who have been trained and evaluated for dressing and who have successfully participated in an aseptic process simulation test (APS) in accordance with their routine tasks."
3. Unauthorized personnel (such as contractors for building or maintenance) shall not enter the Class B clean area or dynamic Class A clean area. If such personnel need to enter under special circumstances, the producer shall establish written procedures for the unauthorized personnel to enter the Class A/B area, and evaluate and record them according to PQS. Authorized personnel within the producer shall monitor the operational activities of unauthorized personnel and assess the impact of these activities on the cleanliness of the area.
4. There should be a system for disqualification of personnel entering the clean room on site, which is based on continuous assessment and/or identification of negative trends in personnel monitoring plans and participation in a failed aseptic process simulation. Once decertified, the operator will need to be re-trained and re-qualified before being allowed to re-engage in any aseptic practice. For those entering A Class B clean area or intervening in a Class A clean area, re-qualification includes consideration of their successful participation in an aseptic process simulation (APS).

Contamination control is the key to ensure the quality and safety of sterile drugs. Personnel pollution control is an important link, so personnel training is particularly important. Follow up with discussion on the health of personnel pollution control, please stay tuned.