Hi! I need to improve the quality systems and documentation in a unit of pharmaceutical company where I’m working. Pls suggest hw to start and go about it. Thanks & regards Indira.S
7th December 2008 From India , Bangalore
Hi Indira, the ISO 9001:2000 quality management system is a comprehensive tool to control quality of both inouts and outputs. It can also be applied to most industry operations. The key here is also not to make these procedures too complex, and that staff be part of the process in developing suitable procedures.
8th December 2008 From Australia ,
Hello Sir! I think both go hand in hand ,Process and documentation. We should document what we do, and do what we document. Indira.S:-)
8th December 2008 From India , Bangalore
Hi Indira, the process and documentation go hand in hand. It is essential that the process be mapped out or flow-charted into steps and resources allocated. The flow chart can then be writtent into easily read procedures.
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 ,
dear indira,

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
Dear Indira,The ISO standard has been revised and all new aspiring companies should do documentation as per ISO:9001-2008.Even the existing certified companies shall have to get recertification within 1 1/2 years.The manual will contain management and the team's committment to follow ISO:9001-2008. The set of procedures followed have to be documented in a separate documentation.Formats have to be designed to meet the ISO:9001-2008 requirements.For any further clarification pl use my e-mail ID:prutheesk44@yahoo.co.in.S.K. PRUTHEE
10th December 2008 From India , Delhi
Hello Indira,
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
sudhir varma
12th December 2008 From India , Bangalore
Hello Partners in learning I also need to document and write the process for a chain of coffee shops. Would be very helpful if there can be any help or examples attached Thanks Abbas
18th December 2008 From Indonesia , Jakarta
Im in Quality dept in a call centre, the avenues seems to be less and consideration for quality to ops as team leader is very less why is that? Any particular avenue that needs to be improved in general?
21st December 2008 From India , Madras
.....anyone who requires any sorta material on Quality Management may please email me the requirement, and i’d send you that....
22nd December 2008 From Pakistan , Karachi
Hi Indira,
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 ....
Good begining...
26th December 2008 From India , Visakhapatnam
Hello Sir !
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
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