[original] light detection of key control elements of sterile drugs

The defects in the light inspection process are one of the major defects in the GMP inspection of sterile drugs in China The light inspection is a key process in the production of pharmaceutical preparations and an important aspect of GMP inspectors' attention There are also defects in the light inspection process in the recently released 483 report In 2014, ECA established a working group on visual inspection, and the new chapter on injection inspection prepared by USP also came into effect on August 1, 2017 The problem of lamp inspection is more and more concerned by GMP inspection, so pharmaceutical enterprises must strengthen the management of lamp inspection process to avoid similar problems in the defect of lamp inspection Now we will discuss how to manage the lamp inspection process in sterile drugs: at present, the lamp inspection of sterile drugs can be divided into manual inspection, semi-automatic inspection and full-automatic inspection The following mainly introduces the key elements that affect the effect of manual lamp inspection and the verification activities of automatic lamp inspection The semi-automatic light detection method refers to these two methods 1 The life cycle of the inspection method based on the life cycle can be represented by the following figure: first, according to the production history data, identify the types of defects (particles) that have appeared before, summarize the frequency or quantity of defects found, and judge the size range of particles Secondly, determine the control parameters of each relevant production process Third, analyze the source of defects Fourth, optimize production / process control and implement effective particle load control measures Fifth, carry out daily monitoring and regular confirmation 2 The basic process of lamp inspection is as follows: the lamp inspection method for sterile drugs recommended by USP: 100% inspection is required for the filled products The unqualified products shall be recorded and trend analyzed; the qualified products shall be packaged after further sampling and testing Generally, according to the method of GB2828, according to the batch size, determine the appropriate acceptance quality limit (AQL) to control For different types of defects, develop different AQL For example: 3 The key elements of artificial light inspection can refer to the following fishbone diagram: 3.1 The temperature, humidity, noise, wind speed and other factors in the working environment room will affect the operators, and it is also necessary to note that the lighting in the room should not affect the illuminance of the light inspection position 3.2 the illumination is generally required to be 2000-4000lux, and the transparency, color, form, size, dosage form and other factors of the vial shall be considered for the specific illumination value The background of light inspection includes white background and black background In addition, what kind of lighting source should be used should also be considered in the design of lamp inspection process 3.3 personnel confirm that first of all, there are vision requirements for the light inspection personnel Secondly, the working hours of the light inspectors should not exceed 4 hours Again, before taking up the post, the light inspection personnel shall undergo strict training and confirmation, and conduct regular assessment or qualification re confirmation For validation, three consecutive successful lamp inspection challenge tests should be completed Reconfirmation is an inspection and test of personnel status Special tests can be used, or reconfirmation can be performed simultaneously in production Both of these methods are feasible Enterprises should select reasonable and appropriate methods to reconfirm personnel on a regular basis according to their own conditions The reconfirmation period is generally 3-6 months Reconfirm at least once a year per person 3.4 it is recommended to adopt a life cycle based approach for the development of inspection procedures, as mentioned above That is to say, from various possible sources of particles, from the product development and process design stage, the control measures for pollutants are considered, including the basic design of inspection method The design of manual inspection method should consider the factors of personnel, environment, products, appliances and so on Ergonomic factors should be designed into the inspection method 4 Verification and result judgment of automatic lamp inspection machine it is a common practice to use challenge samples to verify the automatic lamp inspection machine 4.1 preparation of challenge samples challenge samples can come from unqualified products produced in actual production, or from samples manufactured manually Regardless of source, challenge samples must be able to represent all kinds of defect samples that may be produced in production 4.2 after the maintenance of challenge samples is confirmed, challenge samples with different defects will be formed into challenge sample group for daily monitoring of lamp inspection machine The maintenance procedures of challenge samples shall be established to determine the use and update rules of samples 4.3 the maintenance of confirmation / verification status shall regularly use challenge sample group to test the full-automatic lamp inspection machine to confirm its verification status The frequency of testing shall be determined based on the results of risk assessment It is concluded that lamp inspection is a key step in the production of sterile drugs, which plays an important role in ensuring the quality of products It is an important guarantee for the successful implementation of product inspection and product packaging integrity to deeply understand the regulatory requirements and key elements of the lamp inspection law, reasonably design the lamp inspection operation procedures, and improve the verification of automatic lamp inspection machine Reference [1] Chinese Pharmacopoeia 2015 edition [2] Appendix 1 of GMP sterile drugs [3] USP visual inspection of injections USP injection light inspection [4] PDA survey 2014 visual inspection PDA 2014 light inspection survey [5] GB / T 2828.1-2003 counting sampling inspection procedure Aoxing pharmaceutical life cycle compliance consulting service department was established in 2000 It has many GXP experts from developed countries in the global pharmaceutical industry, well-known domestic GMP experts and international registered consultants, and cooperates with foreign consulting agencies The service department, based on the global Zui new regulations and guidelines, takes the pharmaceutical quality system as the center, and provides GXP compliance services in line with the requirements of FDA, EMA, CFDA, MHRA, PIC / s, who, etc for the pharmaceutical industry through a strong project management implementation team, experienced foreign consultants and experts, as well as a complete set of European and American advanced verification instruments So far, we have served hundreds of pharmaceutical enterprises Based on the concept of customer satisfaction as the center, Aoxing provides pharmaceutical industry with consulting services covering drug life cycle compliance from R & D quality system consulting, technology transfer consulting, verification consulting and testing, data reliability consulting, quality system consulting, operation consulting, registration and approval and training, etc To promote the comprehensive management level of domestic pharmaceutical enterprises and emerging countries to European and American standards Official account No 2 Disclaimer: edit the above content, neutrality of the statement and judgement, and provide no express or implied guarantee for the accuracy, reliability or completeness of the contents contained For reference only, please take full responsibility.