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cg781025

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注册: 2006-06-03
专业: 药物学其他科学问题

[交流] 【国外官方检查】WHO-PQ检查我公司发现的问题

以下是WHO-PQ检查官今年在检查完我所在的公司后给的问题的draft版（正式的得回WHO后才能给），有些问题我在其他公司也常看到，供大家参考：

郁闷！怎么能上传附件啊？只能粘贴上来了：

1. The document used to record the visual check of the income material did not list the different items to check, as damages, presence of seals, CoA, conformity of the supplier with the qualified supplier.
2. Raw materials were found in the warehouse packed in drums with no original indication of the manufacturing site (either no label or the label of the trader). This doesn't guaranty that the material was purchased from supplier approved by the quality unit.
3.    In the validation master plan, the validation of the compressed air was mentioned although it was not done, and not considered as to need to be validated as not in contact with the products and therefore not likely to affect the critical quality of the products.
4. The sampling of the liquids, even those used in the last steps of the synthesis or the purification was done outside without protection of possible contaminants.
5. The validation Master Plan as well as other quality related documents were approved by the General Manager up to 2006 and only reviewed by the QA Department. Although this practice has changed, documents are still used without approval from the QA Department.
6. The periodicity of review of the documents is not mentioned on the documents itself, but in a general procedure. Nevertheless this general procedure doesn't identify and describe the existence in fact of documents having two different review periodicities. One of one year and the second of two years.
7. The validation of the vacuum drying of Nevirapine did make reference to the completed qualification of the dryer.
In the qualification of the dryer there was no documented evidence that the heating system and the associated measuring device was performing as intended throughout the anticipated operating ranges.
The document didn't either specify the water content, before drying, of the three batches dried in the operational condition to qualify the equipment.
8. There were no dedicated logbooks for the equipment but loose sheets of paper, not numbered.
9. In the annual quality review of xxxx (product),
- the residual solvent xxxx was nor reviewed although a limit is tested in the specifications,
- there was no review of results of stability monitoring programs
- the reprocessing of  batches failing to meet the specifications was not discussed.
10. In the Master Batch record, when leftovers of commercial batches are introduced in the manufacturing process to be re-crystallized, there is no mention of the results of the quality control of the batches and the information asked and given is not sufficient to allow traceability.
11. There was no date of cleaning on the small equipments. This didn't allow to clean again the tool, in case the time elapsed since the last cleaning could affect its cleanliness.
12. The tanks containing ethanol T 303 and T 304 as well as the connected pipes are not identified as containing ethanol although they are supposed to be dedicated to this product.
The content of tank T305, supposedly recovered ethanol is no labelled as such and there is no batch or control number of the recovered solvent assuring that it meets the appropriate specifications.
13. There is no description of the cleaning of the sand filter and the activated carbon filter. According to the records, both are rinsed during 1.5 hours, but this duration is not mentioned in a SOPP and thus not justified.
There is no record of the replacement of the UV lamp of the water system, except un label generated and placed on the lamp by the operator performing the replacement.
14. In  the calibration records there is no reference to the certified standard used .
15. An entry was done in the batch record of the manufacturing of Zidovudine at 17 h 30 although the time when the activity was supposed o be monitored and recorded was 17 h10 Furthermore, the time entered was wrongly 17 h10. the activity was not entered at the time it was performed and was falsely entered to mask this deviation.
16. The batch release procedure describes several steps to be performed by the workshop manager, the production manager, and the QA .This steps are not recorded.
17. In the SOP specific to an operation during which APIs are handled after purification, there is no mention of the need to wear gloves. This is described in a general SOP, but not likely to be followed as the gloves are not available at the place were they are used.
18. Process validation of xxxx and xxxx was due to be done in December 2006 and thus not yet finished.
19. The delegation of responsibility for batch release was not formalized by writing.
20. The document allowing the transfer of the finished product from the workshop to the warehouse where it is considered as conform and released and which is the document authorizing the physical release of the product is not foreseen with signature of the QA person.
21. It is not clearly mentioned in the relevant SOP that the API starting materials should be tested and there is no list of starting material considered as critical.
22. Although the N2 is in contact with the product in the last steps and even after purification, there is not a minimum of one full analyse performed at appropriate intervals to compare the specification of the N2 with the results written on the certificate of analysis of the supplier.

[ Last edited by cg781025 on 2006-8-2 at 17:07 ]

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