Equipment & Calibration
Before using a calibrated measuring device this item on the device should be checked to confirm its calibration has not expired.
What is a Calibration tag?
A label indicating that a material or component cannot be used and must undergo testing prior to release and use.
What is: a Quarantine label
Also accept: Hold
A minimum of 1 lot of each drug product must be enrolled in this lab program each year. Additional lots may be required following process changes or non-conformances.
Hint: This program involves long term testing.
What is Stability.
The maximum number of different materials that can be sampled at a time.
What is 1?
This system is used to set and schedule equipment preventative and corrective maintenance.
What is Mainboss or PM Program
This area is used to store materials that are not suitable for use and are to be disposed of.
What is the rejected goods area?
A request from a manufacturer to return or cease use of a product after the discovery of safety issues or product defects that might endanger the consumer or put the maker/seller at risk of legal action.
What is a Recall?
This is the maximum number of APIs that can be pooled together in a composite sample.
What is 10?
This is a description of maintenance or work to be completed for a piece of equipment or system. Hint: they are generated by Agrisan’s PM Program.
What is a Work Order?
A method used to demonstrate that a process will consistently produce the expected results under specified conditions.
What is validation?
Alternate: Qualification
This material of established quality and purity is used as a reference material in laboratory analysis (e.g. HPLC testing).
What is a laboratory reference standard (primary or secondary).
The equation that describes the number of excipients or non-active raw materials, to be sampled.
What is sqrt(n) + 1?
(Square root of n + 1.)
The process of comparing a measurement from a device under test to those of a standard of known accuracy. An adjustment is often made to correct the error and align the device with the standard.
What is calibration.
Finished and packaged product is held in this location until product testing is complete and material has passed inspection.
What is Finished Goods Quarantine?
The length of time that product retains, and all related production documents must be kept.
What is 1-year past expiry?
The labelling for all drug products must include this number, which used to trace a unit back to its production day and records.
What is a lot number?
This type of water purification uses a semi-permeable membrane to separate water molecules from other substances. It can remove dissolved or suspended chemical species and bacteria.
Hint: Agrisan’s is located upstream of the USP.
What is RO (Reverse Osmosis)?
A structured and documented plan that describes actions taken to investigate the assignable cause of an OOS, OOT or other non-conformance. It often includes re-sampling instructions and lab tests.
What is: a test plan, investigation plan?
Alternate: request for additional test/sample form QC-24c.
A technique used in analytical chemistry to separate, identify and quantify specific components in mixtures. It relies on high pressure pumps which deliver solvents through a system delivering it to a column filled with solid particles made of adsorbent material and separates them based on their interactions.
What is HPLC (High performance liquid chromatography; High pressure liquid chromatography)
The specification sheets for these items must be completed & released by QC/QA prior to being moved into inventory (list 2).
What are: raw materials and packaging components?
Alternates: labels, printed packaging