Medicine | Pharmacy | Chemistry


API Manufacturing – Complaint Regarding The API

Posted November 9, 2016 by Matt in Uncategorized

Customer Services

If any complaint received should be managed urgently depending upon the severity of the problem and

should be acknowledge by the API manufacturing.

Any complaint regarding the API should be held respective and documented and reported to the API

manufacturing to resolve the issue

In any case of critical or life threatening situation should be reported to the national or local security and

work in collaboration with the API manufacturing to resolve the issue and seek advice for future


API clinical trials

A quality unit establish that would work as a separate entity of the organization that can approve or

disapprove the selected API manufacturing proposed during its development phase.

Quality measures should be approved and promoted as quality measures of raw material API or

intermediates and packaging should be organized.

Equipment should be calibrated before testing and clean materials should be managed to reduce the effect

of cross contamination

Raw material should be evaluate before procedure and actual yield should be tried to be implemented

before expected yield

Changes provided in the API should be acknowledge and should be documented as changes are in the

course of development of the project

Dates of all prototype API should be preserved for later testing

Documentation regarding the clinical trials should be maintained to have the consistency and reliability of

productsystem should be maintained that checks the overall analytical and actual value resulted in process

Criteria regarding the expected output should be maintained via the organizational policies

In any course of contamination of the API the API should be reprocessed depending upon the severity of

the contamination may result in destroying the Complete API if necessary in the course of this action the

individual held accountable would be investigated and all documentation prior to any outfall will be

reported to the desire personnel .

1. Customer should be listened and recorded

2. During clinical trial it is important to maintain cleanliness and reduce effect of micro organisms

3. Raw material should be kept packed and safe and used when necessary

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