Dear Forum!
Thanks for always interesting information. As usual - there is a problem that needs your consultation.
I am trying to make a regular QA check reports of our production more or less “readable” for our management.
E.g. now it is something like “we found a label missing” or “we found a personnel without gloves”.
I want to make all discrepancies countable, with some graphs.
Maybe you can give me some template or advise a programme (adopted for Pharma, because for Pharma even one critical discrepancy can cause serious harm) of how you perform that?
Russian inspectors still insist on the “simple written form” but our management goes crazy of these "assays"
Thanks in advance,
Maria.
Honestly the simple form of a check list can be prepared after rewiening atleast 10 batch records.
You can review the missing items, decrapencies, Deviations etc from those.
If you still not clear about this I can post a check list depending up on dosage form you make at your facility.
Dear Durga,
thank you for your reply.
Now I am not speaking about some statistical review, I am speaking about a situation when you check your production (for GMP, GEP, EHS requirements e t.c.+internal SOPs) and then make a report. We do it every week+everyday check by QC department. But we write a simple written report, our management wants to see figures.
I know that food companies have a standard excel-file where they put quantity of deviations of any grade found and then a programme counts a percentage of “production conformity”. But for them some critical defects are acceptable and they can have 83 % conformity level with 3 critical problems (e.g. label missing, dirt on the machine etc) For us even one critical defect must make a zero-conformity because it is potentially dangerous for a patient. They make it in this way (sorry for the format)
Grade Amount of deviations Result Comments
(A) (B) (AxB)
Facilities
1.1 Walls, floors 4 3 2
1.2 Doors 4 2 8
1.3 Windows 2 1 2
1.4 HVAC functioning 5 5 0
2. Personnel
2.14 Proper clothes 3 0 0
2.15 Personal hygiene 5 0 0
3. GMP.
3.1 Cleanness 5 1 5
3.3 Labelling 2 1 2
3.4 Closed doors 1 2 1
3.9 SOPs, instructions are in place 3 1 3
total
Total
Goal for this period
We produce finished forms: tabletts, capsules, creams and non-sterile licquids. Will be grateful for any help.
1 Like
Iam in a bit hurry today to attend my danish school.
By tomorrow morning I shall post a check list or checklists I have for oral dosage forms.
It might help you too.
As far as your approach is concerned its very apt for the situation.
But reviewing atleast 10 BMR & PMRS is a good idea.
We know what and where the pit falls are and wht we have to speed up and make better.
I will also post some of the areas from where the questions will arise.
Regards
Dear Durga,
thanks a lot for the documents.
Now I am going to persuade my GM that all companies have the same approach as we are - no percentages.
From the following:
[b]
- GMP material used during training work shops.
2.GMP regulatory guidances.
3.Reviewing atleast 10 BPR’s.
4.Common mistakes: Make some trend analysis.
5.Common SOP errors made.
6.How good your team/ supervisors/Workers/Ececutives/ Managers read SOPs and explain how particular step is performed. - Regular cheking of the weighing Tags, Cleaning Tags, Inprocess slips, Storage Tages, Packing line slips, Filling line cleaning Tags, Dirty or to be washed materials tags, Goods lying in prockets in between 2 zones and areas during peak production schedules.
8.Behaviour of personnel and their lingual skills.
9.Process of entry of Raw materials, Semi finished products, Goods to be packed, Partially packed, Fully packed and labelled and Goods in quarentine: All these stages must be properly looked and checklists can be made.
Check lists give a freedom of confidence to both QA and production. Its a small guidance that everything is proper before any material leaves to next phase.[/b]
Dear Durga Prasad,
Thanks a lot for the checklists and others techenical guidelines.
You will be glad to know that I am going to be handled whole plant’s activity from next month onwards, all these will help me lot.
With Warm Rgds
Sanjay Garg
sanmut@rediffmail.com
Congratulations Sanjay!!
If any help you need do post questions.
We are always ready to help you.
Regards
These are very good documents.
Thanks for uploading thses checklists, useful for all. Inaddition to the above checklist, here is the checklist for RM warehouse ( may be extensive, tried to cover all aspects)
CHECKLIST RM warehouse.doc (349.5 KB)
Thanks for uploading thses checklists, useful for all. Inaddition to the above checklist, soon i’ll upload PM warehouse checklist also
Regards
S.Ranjithkumar
eMAIL : ranjith2875@indiatimes.com
Thank you! These documents are useful.
Welcome.
You too can support the whole community by posting new check lists or documents when ever you make.
You can ask questions and people across the globe will respond to your posts.
Its free and open for all professionals in Lifescience and supporting industries.
Regards
Thank you very much…its very useful document in any p[harmaceutical