8th December 2008 From Australia ,
8th December 2008 From India , Bangalore
The advanced procedure development take into account Safety, Health, Environment issues. This woudl transformt eh ISO9001 std. to ISO 18000. However, seeing that it sound that you are starting this for the first time, it is recommended that you start with ISO9001:2000.
Hope this helps.
9th December 2008 From Australia ,
its not the same. if you are only a document controller then your work is only to keep documents in proper accessible method. you have nothing to do with process/ production.
on the other hand if you are QA/QC or Production/execution engineer then yo hav to refer document to execute the work.
so according to your job responsibility you have to continue with document.
if you are document controller then you have to handle all departments document in proper file but if you are only production people then only you have to keep you process related document to follow the path.
on the other hand if you are related to legal/commercial section then all documents are important for you to fight against any dispute.
if you have ERP system for that then ou have to fllow your companies system. but to put in excel just scan all documents in PC. then enter in excel, the required documents serial wise which is for your department. and write down in the subject so that you can know which data you want and then link it to the scanned related document. thsi process will allw you to access any paper or method you want in respective time.
even you have to enter during the process, the reference number of method you followed. so any correction, you can rectify in that method.
9th December 2008 From United Arab Emirates , Dubai
10th December 2008 From India , Delhi
I f you are looking for only one unit of the pharma company then you should :
a)identify all the processess in that unit.
b)map the processess as flow charts
c) identify people responsible for each operations.
d)identify the resources required for each operation.
e)write a brief and effective procedure to be followed including the formats and records to be used.
I f your company is planning for GMP certification then almost 90% of the documentation and procedures will be in place.
I f you have any queries write to me .
Thanks & Regards
12th December 2008 From India , Bangalore
Pharma companies are also called process industries..the quality and safety system is required to be quite stringent.
Kindly get a copy of ISO 9001-2000 standard..( i can sent you , if you dont have one).
Prepare a complete flow chart(men,material and process) of the organisation..which should include incoming of material etc.
With the help of flow chart ,check the documentation currently in use. or if documents are not there construct flow chart as per the process currently in use...
finally check with the standard , analyse the gaps ....
26th December 2008 From India , Visakhapatnam
Glad to know you!
Yes, we are following some SOPs , Equipment ( operation and cleaning),few made by us & few compiled from here and there. But as a QA ,I feel they are not enough to create the actual GMP awareness among our people.I need some help regarding general SOPs,of Production,QA,QC,Housekeeping,Maintainence etc.,
Which guidlines would help me the best to prepare these documents?
29th December 2008 From India , Bangalore