Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-023.00 Effective date: mm/dd/yyyy
Approved by:
7. All the log books (equipment/area usage records) are updated.
8. Batch-related documentation is on time, complete, and correct.
42.3.2.4
liquid dosage Production area
1. Temperature indicators having valid calibration tags.
2. Workers (coming into direct contact with products) are wearing clean masks and gloves.
3. All the products have status label.
4. Batch-related documentation is on time, complete, and correct.
5. All the log books (equipment/area usage records) are updated.
42.3.2.5
Packaging
1. All packed units after completion of batch are kept in the finished goods area in stores.
2. All coded and uncoded labels and boxes are kept in cages with identification label.
3. Workers coming into direct contact with the product are wearing masks.
4. Operators wear disposable gloves while handling the product.
5. There is proper physical separation/segregation between the lines.
6. Temperature and humidity records of dry and soft packaging areas are updated and
maintained.
42.3.2.6
cephalosporin and Penicillin Production area
1. Operators are wearing a mask and gloves and using a beard cover when necessary.
2. Relevant cleaning procedure for the area and equipment should be followed.
3. Work areas are clearly labeled.
4. All vessels and utensils are labeled as to their cleanliness status.
5. Manufacturing instructions are at hand during processes and are approved and accurately
followed.
6. Vessels should be labeled with product lot number and the stage of processing.
7. Air inlets and outlets are functional.
8. Material holding containers are intact and can be closed completely.
9. Materials and personnel flow is dedicated and being followed.
10. Temperature and humidity are within the limits.
42.4
documentation
42.4.1
g
ood
d
ocumentation
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killS
1. The correct ink color and type and the proper writing instruments are used (pencils must
not be used).
2. Additional documents (e.g., charts, printout) are properly included.
3. The printing and writing can be easily read.
4. Errors are properly corrected with one line through the original entry, initialed, dated, and
the reason explained (if necessary).
5. Calculations are reviewed and verified.
6. Numbers are properly rounded off; the correct significant figures are used.
7. The spelling of the product names and other words is correct.
8. Lot numbers and product ID codes are double checked and are correct.
9. Information is recorded as it is obtained.
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