Confirmation and validation
Article 1 This appendix applies to the scope and content of the validation involved in the "Code of Practice for the Quality Management of Pharmaceutical Business" (hereinafter referred to as the "Code"), including the validation of the cold storage, refrigerated trucks, refrigerated containers, warming containers, and cold storage and transportation of temperature and humidity automatic monitoring system, etc., and confirms that the relevant facilities, equipments And the system can meet the specified design standards and requirements, and can be safe, effective normal operation and use, to ensure that the refrigerated, frozen drugs in the storage, transportation process of drug quality.
Second, the person in charge of enterprise quality is responsible for the supervision, guidance, coordination and approval of the confirmation and verification work, the quality management department is responsible for the organization of warehousing, transportation and other departments **** with the implementation of the confirmation and verification work.
Article 3 The enterprise should be in accordance with the provisions of the quality management system documents, according to the annual development of the verification plan, according to the plan to determine the scope, schedule, project implementation verification.
Article IV enterprises should be validated in the process of implementation of the establishment and formation of validation control documents, including validation programs, standards, reports, evaluations, deviations and preventive measures, etc., the validation control documents should be deposited in the drug quality management files and preserved in accordance with the provisions.
(a) The validation program should be based on the specific content of each validation work and requirements were developed, including the implementation of the validation of personnel, objects, objectives, test items, validation equipment and system description, test point layout, time control, data collection requirements and implementation of the validation of the relevant basic conditions, the validation program should be approved by the quality of the person in charge of the review and approval can be implemented;
() (B) the enterprise should develop the implementation of verification standards and verification procedures;
(C) verification should be issued after the completion of the verification report, including verification of the implementation of personnel, verification of the process of data collected in the summary of the data analysis charts of each test item, the results of the test item analysis, verification of the results of the overall evaluation, etc., the verification report shall be responsible for the quality of the review and approval; (D) the validation process should be According to the verification of the actual situation, the operation or use of facilities and equipment may not meet the requirements of the situation, the system parameters set unreasonable deviations such as processing adjustments and corrections, so that the relevant facilities, equipment and systems operating conditions in line with the specified requirements and standards;
(e) should be based on the results of the validation of the possible existence of risks affecting the quality and safety of pharmaceutical products to develop effective preventive measures.
Article V. Enterprises shall implement validation according to the validation program.
(A) the relevant facilities, equipment and systems in the new put into use before or after the transformation should be carried out before the use of validation, design or predetermined key parameters, conditions and performance of the test and confirmation, to determine the actual key parameters and performance in line with the design or the specified conditions of use;
(B) when the relevant facilities, equipment and systems to change, exceeding the set conditions or use, or the occurrence of equipment When serious operational abnormalities or failures occur, the causes should be sought, risks assessed, appropriate corrective measures taken, and the effects of rectification tracked until the performance and parameters are confirmed to be in compliance with the specified standards;
(c) Periodic validation should be carried out on the relevant facilities, equipment and systems to confirm that they are in compliance with the specified requirements, and the interval between periodic validations should not be more than one year;
(d) The following should be carried out According to the design parameters of the relevant facilities, equipment and systems, as well as the conditions of use confirmed through verification, respectively, to determine the maximum time limit for decommissioning, when exceeding the specified maximum time limit for decommissioning, need to be re-activated before the risk should be assessed and re-confirmation and verification
Article 6 Enterprises shall, in accordance with the content and purpose of the validation, to determine the appropriate validation items.
Cold chain validation, cold storage, refrigerated trucks, etc. Validation process slightly.
(d) The data collection time shall not be greater than 5 minutes.
Article IX shall ensure that all validation data are true, complete, effective, not to be tampered with, traceable, and preserved in accordance with the provisions.
Article 10 of the validation of the use of temperature and humidity sensors should be calibrated by the statutory metrological institutions or verification, calibration or verification certificate copy should be used as a necessary annex to the validation report. Validation of the use of temperature and humidity sensors should meet the following requirements:
(a) should be applicable to the measurement range of the equipment being validated;
(b) the maximum allowable temperature error of ± 0.5 ℃;
(c) the maximum allowable relative humidity error of ± 3% RH.
Article XI of the enterprise should be based on the validation of the parameters and conditions identified, correct, Reasonable use of relevant facilities and equipment, without verification of the facilities, equipment and systems shall not be used for drug refrigeration, freezing storage and transportation management.
The results of the validation should be used in the development and revision of quality management system documents.
Article XII of the enterprise entrusted storage, transportation of refrigerated or frozen medicines, should be in accordance with the relevant provisions of the "norms" of the entrusted party quality system audit, the entrusted party refrigeration, freezing-related facilities, equipment and systems do not meet the requirements, as well as not verified, shall not be entrusted to the storage and transportation.
Article 13 The enterprise may entrust the third party organization with the corresponding ability *** with the implementation of the validation work, but the enterprise shall ensure that the implementation of the validation of the whole process in line with the "norms" and the requirements of this appendix.
The above content is provided by "Beijing Longbang Technology" pharmaceutical GSP temperature and humidity monitoring experts.
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