Warning Letter: FDA criticises Supplier Qualification

beiwei5du

Warning Letter: FDA criticises Supplier Qualification

In a recently published Warning Letter, the FDA accuses a pharmaceutical company of hiring an auditor to audit a contract manufacturer, but of having no results or conclusions on the audit.

In addition, the company failed to establish appropriate written responsibilities and procedures for the control of externally produced batches. The company had asked the contract manufacturer to take over manufacturing and packaging activities. The quality agreement stipulated that both sides were responsible for compliance with the relevant cGMP requirements, while the contract manufacturer was solely responsible for the approval or rejection of all products. However, the FDA does not allow the final control and approval to be assigned to an external partner (this would be possible according to EU GMP). It considers the marketing authorisation holder and contract giver to be responsible for the final review and approvals of all batches. This should also be described in the contract.

Warehousing has also been assigned. According to the FDA, storing drugs in an external warehouse is a cGMP activity. The selected warehouse, however, had declared that this was "not applicable" and that the employees were not trained in GMP either. According to the FDA, the warehouse should never have been approved and used.

For more details please also see the FDA Warning Letter to Vilvet Pharmaceutical.

beiwei5du

三个问题：
1、委托审计
2、委托生产
3、外包库房希望大家可以讨论。

Doitasyoulike

没什么刺激点
无非是不符合GMP而已
和中国一样，成品的最终检验和放行不能完全委托外部实验室

beiwei5du

the FDA does not allow the final control and approval to be assigned to an external partner (this would be possible according to EU GMP).


EU GMP未找到相关的具体规定，是指没有规定可以？？大家能否提供相关的线索呢？@Doitasyoulike

beiwei5du

FYI
FDA法规

PK愚公想改行：对于288条款解读的不同意见

beiwei5du

Lack of quality control unit procedures
Your firm lacked written procedures regarding critical quality control unit functions. For example:

• Your quality agreement with (b)(4) states that they will notify you of any process changes and provide you with batch records and final yields. However, you had insufficient related procedures.
• The 1-888-705-4369 telephone number on your drug product labels for reporting Vilvet product complaints connects to your firm’s voicemail. Consistent with your quality agreement, your supplier is responsible for investigating complaints. However, you lacked procedures to handle and oversee complaints such as quality and adverse events, including how you would refer complaints to your supplier to investigate.
• Our investigator asked your Accounts Manager how Vilvet is notified of out-of- specification (OOS) or out-of-trend (OOT) results from your supplier, (b)(4). Your Accounts Manager stated that your supplier, (b)(4), is required to notify you via phone or email. However, your firm lacked procedures for handling such results.
• You also lacked additional relevant procedures including, but not limited to, review and assessment of stability data, and development and approval of release specifications.
  
  

Inadequate quality control unit procedures
Quality unit procedures were inadequate. For example:

• You did not have a designated individual or department to fulfill the quality unit’s responsibilities at the time of inspection(检查时没有internal quality unit，使用顾问代替）.
• You contract out your warehousing. Holding drugs in a warehouse is a CGMP activity. In your Vendor/Supplier Questionnaire, your contract warehouse (b)(4) stated that it is “not applicable” for them to train their employees on good manufacturing practice and “good documentation practices.” Your procedures were insufficient to prevent you from approving the questionnaire and using the warehouse. （填表与批准要仔细啊）
  

syhorchid

了解一下