第九个observation如何理解？？？

beiwei5du

USFDA OBSERVATIONS AT Dr Reddy's API PLANT

Update 2015 May 28: Click here to see the orignal form 483 issued to Dr Reddy's

Observation 1

Lab records don't include complete data derived from all tests. The inspectors indicate five instances where all the test failures were not documented and reported as per standard operating procedure (SOP). The reported results don’t contain the earlier sample analysis.

Observation 2

The inspection highlights unauthorised access to computer system. An instance was noted where data was deleted by an unauthorised person.

Observation 3

The Batch production and control records didn’t have the entries filled after each and every step as required by SOP. The data were filled simultaneously.

Observation 4

Procedures regarding the issuance, revision, superseding and withdrawal of documents not followed.

Observation 5

Water used in the manufacture of APIs is not established to be suitable for use. The microbiological test methods were not verified and validated.

Observation 6

Record of training of operators not maintained properly.

Observation 7

Failure to justify and follow up on deviations or batch failures: The inspectors made two observations where a batch has failed on certain parameters. Either the investigations are incomplete or the conclusion was not satisfactory.

Observation 8

Process validations: The inspectors raised questions on the process validation approach that would ensure that the process can be performed effectively and reproduce the desired results. The inspectors highlight a case of significant numbers of reprocessing carried out by the company, raising questions on the process.

Observation 9

Adequate and clean washing and toilet facilities are not provided for personnel. The inspectors highlight that toilet facilities are located at a long distance.

globle001

卫生间太远，耽误工作

beiwei5du

erious concerns at Zydus Cadila

Quality Executive Partners Inc, also posted the redacted Form 483 issued to Cadila Healthcare’s Zyfine unit (also known as Zydus Cadila), which was inspected by the U.S. FDA in December 2014. The facility, located in Ahmedabad, India, had a series of glaring data-integrity observations, which ranged from:

• Records were not made readily available during the inspection; the Vice President, Corporate QA stated that the requested document was located at an employee’s home.
  
• During the FDA walk through the inspectors found five original and rewritten records, which were falsified.
  
• Inspectors found rough notebooks in the scrap yard as well as the engineering and QA offices.
  
• Documents were signed and dated by individuals who were not present at the site.
  
• Reprocessing was performed without review and approval of the quality unit.
  
• Batch records were not reviewed by production and QA personnel before release.
  
• Washing and toilet facilities lacked soap.
  

beiwei5du

globle001 发表于 2016-10-30 22:01
卫生间太远，耽误工作

q7a
4.15 Adequate, clean washing and toilet facilities should be provided for personnel. These washing facilities should be equipped with hot and cold water as appropriate, soap or detergent, air driers or single service towels. The washing and toilet facilities should be separate from, but easily accessible to, manufacturing areas. Adequate facilities for showering and/or changing clothes should be provided, when appropriate.
21CFR 211
§211.52   Washing and toilet facilities.

Adequate washing facilities shall be provided, including hot and cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily accesible to working areas.

就是不知道adequate,easily accessible to,这些检察官是依照什么标准进行判定的,所以还是需要在检查期间，将卫生间卫生打扫干净，万一检察官上厕所，影响不好就出问题了。


其实联合国FAO组织的一个7.2.4 Maintenance of facilities for personal hygiene可以参考一下！！！

According to the US Federal Seafood HACCP regulations (FDA, 1995) the condition of the personal hygiene facilities should be monitored separately.

The number and location of toilets and hand-washing facilities needs consideration. An adequate number of readily accessible toilet facilities must be available and maintained in a hygienic condition and good repair. Hand-washing facilities must be strategically and conveniently located near toilets and at entrances to the processing areas. Wash basin taps must not be hand-operated.

Hand-washing facilities should be dedicated to hand-washing only and never be used for washing dishes, utensils or equipment. Similarly, hand-washing should never take place in sinks or tanks used for food preparation. Hand-washing facilities should include:

• liquid soap in a dispenser
• hot water (~40-43°C)
• disposable paper towels or air blowers (- refuse receptacles if needed)
• hand disinfection facilities (bowls for hand dip).
  

Typically hand disinfectants are composed of chlorine compounds (100-200 ppm chlorine) or iodine compounds (20-25 ppm iodine).

Model prerequisite programme: Maintenance of facilities for personal hygiene
Criteria:	Toilets and hygiene areas kept cleaned and in good repair Hand-washing and disinfection facilities must be located at toilets and at the entrance to all processing areas and maintained in a good condition The facilities must be equipped with liquid soap, disposable towels and effective disinfectant dips
Monitoring:	Daily check of facilities for cleanliness and good repair. More than one daily check for concentration of disinfectant dip One person (e.g. the Q.A. supervisor) should be designated to carry out this monitoring
Corrective action:	Immediate repair if facilities are broken down or not functioning properly Replenishing of supplies if lacking or concentration is inadequate
Records:	The daily Hygiene Record form should include all observations made and actions carried out

beiwei5du

globle001 发表于 2016-10-30 22:01
卫生间太远，耽误工作

莫非当时检察官尿急，找厕所找不到，内放了，然后给一个observation

一沙一叶

不方便人员及时的清洁自己

beiwei5du

3557

21 CFR 211.52

Washing and toilet facilities are deficient

Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, ***

6

去年对于制剂检查中有6次提到这个问题。那么针对于API的厕所相关observatio在哪里进行查询呢？？？

阿炳1987

beiwei5du 发表于 2016-10-30 22:12
莫非当时检察官尿急，找厕所找不到，内放了，然后给一个observation

这个很有可能啊

阿炳1987

beiwei5du 发表于 2016-10-30 22:12
莫非当时检察官尿急，找厕所找不到，内放了，然后给一个observation

要不就是检察官比较注重人文关怀

PharmaGMP

厕所其实可以从一个方面反应出一个公司的管理水平，而且厕所不干净本来就是重要的污染因素

叶非

这个不是新要求啊！从我2006年开始接触国外审计，咨询公司到车间第一件事情就是问厕所，看厕所。

叶非

这个不是新要求啊！从我2006年开始接触国外审计，咨询公司到车间第一件事情就是问厕所，看厕所。

ooc

增加设施很容易，关键是有没有相应的管理文件，药文网 有个洗手间的sop，可以看看

cgc717

globle001 发表于 2016-10-30 22:01
卫生间太远，耽误工作

检查更多的是从防止污染的角度看的！

实际上在Q7中也有明确的要求。

我们早在2006年EU-GMP检查的过程中就遇到此类问题了。

cgc717

beiwei5du 发表于 2016-10-30 22:11
q7a
4.15 Adequate, clean washing and toilet facilities should be provided for personnel. These wa ...

楼主对这个问题研究得够深的，佩服！！！

cgc717

uiofer 发表于 2016-10-31 07:15
这个不是新要求啊！从我2006年开始接触国外审计，咨询公司到车间第一件事情就是问厕所，看厕所。

是的。

zysx01234

长知识

cgc717

楼主是怎么能看到别人的483？

那个链接好像是slideshare的，国内上不了！

xqliu

我们当年FDA审计时提出车间的卫生间蹲便要求改为坐便，说是防止喷溅造成污染。说明卫生间还是 比较关注的。

番茄炒蛋

太近了容易造成污染；太远了员工进行清洁的代价提高了，客观减少了其进行清洁的次数，侧面也增大了污染的风险。