【導(dǎo)讀】品儲存的冷庫的溫濕度進行嚴格的控制，必須對冷庫運行進行驗證確認。本方案將實施驗證的冷庫是按照GSP要求設(shè)計制造和安裝的，已經(jīng)實際使用5年，該冷庫占地面積18m2，為整體組裝結(jié)構(gòu)，墻體是中間充填隔熱樹脂的彩鋼板，冷庫溫度2℃～8℃，濕度35%～75%，容積：45M3。建立冷庫驗證方案，證明24小時內(nèi)冷庫內(nèi)的溫度和濕度達到規(guī)定要求，保證安全、有效地正常使用，檢查并確認溫度和濕度是否符合GSP冷藏藥品要求。2020版《藥品經(jīng)營質(zhì)量管理規(guī)范》及其附錄。負責(zé)驗證數(shù)據(jù)的收集、整理、匯總，并對各項驗證結(jié)果進行分析與評價。負責(zé)組織、協(xié)調(diào)完成各項因驗證而出現(xiàn)的變更工作。負責(zé)驗證報告的起草、審核與報批。驗證，該冷庫此前未進行過規(guī)范的預(yù)確認，故本次驗證對預(yù)確認進行補充。

　　

【正文】 ion will be in accordance with regulations to give the corresponding disciplinary action. The original 10 categories of misconduct, integration specification for political discipline, discipline, honesty and discipline masses Ji Law and discipline and discipline and other six categories, the content of rule real return to Party discipline, for the majority of Party members and listed a negative list. 7 2, highlighting the 標題 冷庫溫濕度及調(diào)控系統(tǒng)驗證方案 文件號 起草 日期 修訂號 00 審核 日期 頁 碼 22 of 58 批準 日期 執(zhí)行日 22 / 58 political discipline and political rules. Regulations according to the stage of the discipline of outstanding performance, emphasizing political discipline and political rules, anization and discipline, in opposition to the party39。s leadership and the party39。s basic theory, basic line, basic program and basic experience, the basic requirement of behavior made prescribed punishment, increase the cliques, against the anization such as violation of the provisions, to ensure that the central government decrees and the Party of centralized and unified. 3, adhere to strict discipline in the law and discipline In front, Ji separated. Revised Regulations adhere to the problem oriented, do Ji separated. Any national law existing content, will not repeat the provisions, the total removal of 79 and criminal law, repeat the content of the public security management punishment law, and other laws and regulations. In the general reiterated that party anizations and Party members must conscientiously accept the party39。s discipline, die van ply with national laws and regulations。 at the same time, to investigate violations of Party members and even criminal behavior of Party 標題 冷庫溫濕度及調(diào)控系統(tǒng)驗證方案 文件號 起草 日期 修訂號 00 審核 日期 頁 碼 23 of 58 批準 日期 執(zhí)行日 23 / 58 discipline and responsibility, Regulations distinguish five different conditions, with special provisions were made provisions, so as to realize the connection of Party discipline and state law. 4, reflect Wind building and anticorruption struggle of the latest achievements. rule the party39。s eighteen years implement the spirit of the central provisions of the eight, against the requirements of the four winds and transformation for disciplinary provisions, reflecting the style construction is always on the road, not a gust of wind. In the fight against corruption out of new problems, increase the trading rights, the use of authority relatives profit and other disciplinary terms. Prominent discipline of the masses, the new against the interests of the masses and ignore the demands of the masses and other disciplinary terms and make provisions of the disposition and the destruction of the party39。s close ties with the masses. Discipline to protect the party39。s purpose. 8 of these regulations, a total of three series, Chapter 15, 178, more than 24000 words, after the revision of the regulations a total of 3 series, Chapter 11, 133, 17000 words, divided into general 標題 冷庫溫濕度及調(diào)控系統(tǒng)驗證方案 文件號 起草 日期 修訂號 00 審核 日期 頁 碼 24 of 58 批準 日期 執(zhí)行日 24 / 58 and special provisions and Supplementary Provisions Part 3. Among them, add, delete, modify the provisions of the proportion of up to nearly 90%. 1, the general general is divided into five chapters. The first chapter to the regulations of the guiding ideology, principles and scope of application of the provisions, highlight the strengthening of the party constitution consciousness, maintenance the authority of Party Constitution, increase the party anizations and Party members must abide by the party constitution, Yan Centralized centralized, would examine at all levels of the amended provisions implementing and maintaining Party discipline, and consciously accept the party discipline, exemplary pliance with national laws and regulations. The second chapter of discipline concept, disciplinary action types and effects of the regulations, will be a serious warning from the original a year for a year and a half。 increase the Party Congress representative, by leaving the party above (including leave probation) punishment, the party anization should be terminated its representative qualification provisions. The third chapter of the 標題 冷庫溫濕度及調(diào)控系統(tǒng)驗證方案 文件號 起草 日期 修訂號 00 審核 日期 頁 碼 25 of 58 批準 日期 執(zhí)行日 25 / 58 disciplinary rules of use prescribed in the discipline rectifying process, non convergence, not close hand classified as severely or heavier punishment. Discipline straighten At least eighteen years of five years, these five years is to pay close attention to the provisions of the central eight implementation and anti four winds . The fourth chapter on suspicion of illegal party disciplinary distinguish five different conditions, with special provisions were made provisions, to achieve effective convergence of Party and country 9 method. rule the provisions of Article 27, Party anizations in the disciplinary review found that party members have mitted embezzlement, bribery, dereliction of duty dereliction of duty and other criminal law act is suspected of mitting a crime shall give cancel party posts, probation or expelled from the party. The second is Regulations Article 28 the provisions of Party anizations in the disciplinary review But found that party members are stipulated in the criminal law, although not involved in a crime shall be investigated for Party discipline and responsibility should be depending on the specific circumstances shall be given a 標題 冷庫溫濕度及調(diào)控系統(tǒng)驗證方案 文件號 起草 日期 修訂號 00 審核 日期 頁 碼 26 of 58 批準 日期 執(zhí)行日 26 / 58 warning until expelled punishment. This situation and a difference is that the former regulation behavior has