发表于 2019-3-16 10:39:18
本帖最后由 beiwei5du 于 2019-3-16 11:26 编辑 |
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?。?/font>