308车间受委托代加工注射用丁二磺酸腺苷蛋氨酸0.4g变更： 1. 3

308 processing workshops entrusted with succinic acid injection 0.4g change SAM: 1.308 workshop commissioned by the Ukrainian Farmak, succinic acid injection processing SAM 0.4g, and complete product technology transfer. <br>2. The drafting process validation program, process planning, batch records and other related documents clean limit calculation based on product technology transfer information. <br>3. Batch 1 and pilot production process prescription Principal transfer, in accordance with the test batch process control parameters derived for three consecutive batches of process validation. <br>4. New material 10R in borosilicate glass bottles injection control, and evaluate their supplier, after passing the inclusion of qualified suppliers directory. "

308 workshop commissioned to process injection with dysphonate adenosine methionine 0.4g change: 1. Workshop 308 was commissioned by the Ukrainian company Farmak to process 0.4g of the injection of butyl sulfonate adenosine methionine and to complete the technical transfer of the product.<br>2. Draft the relevant documents such as process verification program, process procedure, batch record and calculation of cleaning limitaccordingtoum according to the product technology transfer data.<br>3. According to the prescription and process transferred by the entrusting party, 1 batch of pilot production shall be carried out, and the process verification shall be carried out in 3 batches in succession according to the process control parameters exported by the test batch.<br>4. New material 10R in boron silicon glass control injection bottle, and its suppliers are reviewed, qualified and included in the qualified supplier catalog. "

Workshop 308 was entrusted to process ademetionine 0.4g for injection. 1. Workshop 308 was entrusted by farmak company of Ukraine to process ademetionine 0.4g for injection and complete product technology transfer.<br>2. Draft process validation plan, process procedure, batch record, cleaning limit calculation and other relevant documents according to product technology transfer data.<br>3. Carry out one batch of pilot production according to the prescription and process transferred by the entrusting party, and carry out three consecutive batches of process validation according to the process control parameters derived from the test batch.<br>4. Add borosilicate glass injection bottle in material 10R, review its suppliers, and list them in the list of qualified suppliers after they are qualified. "