Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-003.00 Effective date: mm/dd/yyyy
Approved by:
22.1 PurPose
To provide written instructions to the QA in-process inspector to draw finished product samples as
per written instructions.
22.2 resPonsibility
It is the responsibility of the QAI to follow the procedure. The QA manager is responsible for the
SOP compliance.
22.3 Procedure
1. The QAI will be available in the packaging area. He will collect samples from each running
line in the final packaging for both testing and reference purposes.
2. A number of samples will be collected as per the attached annexure.
3. The samples to be collected for each finished product will be divided over the process of
packaging and will be collected hourly during audit checks, so that they are representative
of the entire packaging process.
4. Injectables: For the sampling of injectables, the process is as follows:
a. The QAI will collect the samples from the injectables finishing line.
b. The number of samples will be decided as per the attached annexure.
5. The QAI for in-process control will send the following documents to the QC administration
according to the checklist; refer to SOP QAS-000.
6. The samples to be used as reference samples will be kept in alphabetical order in the reference
sample room and will be used in case of any complaints from pharmacies or customers for
reanalysis by the QC laboratory.
7. They will be stored for the time of the shelf life plus 1 year.
22.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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