documentation Flashcards
It is an essential part of a good manufacturing practices. It defines a scheme of information so that risks of characteristic in misconception and/or error in oral communication will be minimized.
Documentation
It subsequently supports the quality, and its uniformity, of all goods and services, as those in charge for the specific operations have clear, definite instructions to follow including active drug substances, is legally mandatory.
Documentation
Coverage of Documentation
• Building and premises
• Personnel
• Equipment
• Materials
• Processing
• Finished goods
• Complaints
It is a specific document compiled, checked, authorized and approved by an experienced personnel as necessary and appropriate.
As with any other documentation, it shall also be open for review. If there are changes, it should be approved by designated staff responsible for production and quality control.
Master formula record
It is one of the function of quality control. This function is performed by alert individual who have understood the written instructions is provide in the SOP on how to inspect certain quality characteristics
Inspection
It is a step by step method on how to go about a specific job. In inspection, should include one of those of the basic types of information needed by an inspector
Standard Operating Procedure (SOP)
the inspector has to know what operation come before and after his inspection
when to inspect
He should know what to look for during inspection
what to inspect
what is acceptable and what is unacceptable for each
characteristics inspected
Inspection Standards
The procedures that will results in the most effective inspection and that will permit reliable interpretation of the results of inspection
Inspection Method
the inspector has to know the data recording and reporting procedures so that the information he provides can be truly reliable
How to report data
he has to know the appropriate actions to take with the materials he handles
Material Handling
the inspector has to know the rules and procedures which govern his conduct on the job
Administrative procedures
AO for Guidelines for Manufacturers and Traders
Administrative Order No. 2019-0007
To provide stakeholders engaged in the manufacturing processes for ENDS/ENNDS products a general overview of FDA’s regulation for manufacturers and traders
Administrative Order No. 2019-0007
To ensure that all concerned stakeholders understand the process for the application of a license to operate and the regulatory requirements during operations
Administrative Order No. 2019-0007
It means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formulating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution.
Manufacturer
They shall be categorized a manufacturer.
Trader