Basic knowledge of drug inspection
I. Basic procedures of drug inspection work
(1) sampling: refers to sampling a certain number of representative samples from a batch of products for inspection according to the sampling rules. General equivalent sampling
(1) When the total number of samples x is less than or equal to 3, take each sample;
② Total number of samples 3
③ The total number of samples is X & gt300, and random sampling is conducted according to the number of samples.
(2) Inspection, identification, inspection and content determination.
To judge whether the quality of a drug meets the requirements, we must comprehensively consider the characteristics, physical constants, identification, inspection and content determination of the drug.
(3) Record and report the truthfulness, completeness and conciseness, and the details of samples and inspection conditions.
Signature: original record (inspector, reviewer)
Inspection report (inspector, auditor, department head, official seal of the unit)
If you make a mistake, you can only cross out your signature.
The real question must have the Drug Inspection Report issued by BCDE.
A. Inspector's signature
B. Signature of department head
C. Auditor's signature
D. Inspector's signature
E. Official seal of the unit
Second, the use and calibration of commonly used analytical instruments
1. analytical balance: there are two kinds of mechanical balance and electronic balance;
Used for weighing samples and reference substances and calibrating titrant in content determination.
What is the sensitivity of a general analytical balance? 0. 1mg 、? 0.0 1mg 、? 0.00 1mg。
When the sampling amount is greater than 100mg, select? ; When the sampling amount is 10~ 100mg, choose? ; When the sampling amount is less than 10mg, select? .
2. Glass measuring tool: The glass commonly used in the laboratory includes pipette, volumetric flask, burette, measuring cylinder, measuring cup, etc.
The allowable error of a volumetric flask is about one thousandth of the volume.
3. Thermometer: Calibration before first use; Analytical instruments: calibrate as required and check regularly.
20 17 Print Entrance of Licensed Pharmacist Admission Ticket