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It's longtime for me toremember my first experience in clean zone.
in July 2009, when I wasassigned to work in solid dosage form production line, my supervisor told methat every new employee would be guided concerning the knowledge of cleaningarea.
A longstanding story about me isstill reminding me anytime.
I remember the words from my operationtutor, a female tutor of about 40 years old, who asked me to carefully observeeach operation.
Also, she told me not to thinkthat whoever you are must obey the SOP, although you got a master degree,I would also blame you for your wrong operation, and everybody should cooperatewith each other.
I felt a little astonishedby her words, before I went to workshop, I always thought that the newemployees, like me majored in pharmaceutical from university, would know moreabout the manufacturing principle and theoretical knowledge, believing that wenew employees can do it better than these old guys who just graduated fromhigher middle school.
However, actually, theresult shows that we just know theoretical knowledge but not the operation,industry manufacturing is different from the lab operation. What’s more, industryequipment is bigger than lab instrument, our workshop manager also told us tolearn from these old operators who have full manufacturing experience and getthe knowledge how to control the quality of granules and tablets. For example,like wet mass, some operators can know whether the LOD of granules by touchingthe granules by hands, opposite to us new employees, we just know it should betested by LOD tester. Moreover, some operators can weigh the quantity requiredby hands without balance, adjusting the quantity of adherent by observing theappearance of granules, in a word, they spent long time manufacturing the sameproducts, as a result, they know the actual operation, we just know a littleabout the principle.
During the first threemonths, we listened to their guidance and operated under their requirement, onthe other hand, we learned how to cooperate and communicate with them, most ofthem would like to tell you about the manufacturing experience of each productof course; in addition, our on-site QA would also went through clean area, meanwhile,we also read product archive to know more about each product’s manufacturinghistory, these documents help understand deeply the critical quality attributes.
As the first three monthswent by, we new employees accepted the examination whether we everyone canproduce and operate by oneself, based on the manufacturing experience and dailyoperation, I passed through that examination.
Thanks to each tutors’guidance, with the help of tutor, I learned how to manufacture products and putmy theory into practice, what’s important is that each university studentshould learn from everybody in the workshop, each operators have full actualexperience which would helpful to the management of quality. Don’t think thatyou get some bachelor or master degree, actual experience is also important inindustry, lowering your status to improve yourself.
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发表于 2018-8-20 07:39:01
置顶卡
变色卡
发表于 2018-8-20 09:56:00
楼主