batch production records

基本解釋

All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch.
所有生產(chǎn)、控制、銷(xiāo)售記錄都應(yīng)保留至該批的有效期后至少一年。
Reviews the batch production records ensure its compliance. Report any problems during review in a timely manner to the QA supervisor for final decision.
理審核批生產(chǎn)記錄確保其符合性。審核中的問(wèn)題即使報(bào)告給QA主管，以便作出最后的決策。
Batch production records should be prepared for each intermediate and API and should include complete information relating to the production and control of each batch.
應(yīng)當(dāng)為每種中間體和原料藥準(zhǔn)備批生產(chǎn)記錄，內(nèi)容應(yīng)當(dāng)包括與各批生產(chǎn)和控制有關(guān)的完整資料。