API Manufacturing – Complaint Regarding The API
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