Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-022.00 Effective date: mm/dd/yyyy
Approved by:
They must be accompanied by an indication of the dates between which they were autho-
rized for use (drug information department).
13. Adverse drug event records (correspondence, records, and reports) or authentic copy must
be retained indefinitely with the Regulatory Affairs and Drug Information Departments.
No such records may be destroyed without the authority of the director QA or the general
manager of the ABC Pharmaceutical Company.
14. Calibration and maintenance records of equipment in the QC laboratory, QA, and R&D
laboratory will be maintained by the manager calibration for a period of 2 years, after
which it will be destroyed.
15. Purchase requisitions will be kept by the purchase department for a period of 2 years after
the date of delivery, after which it will be destroyed.
16. The ABC Pharmaceutical Company Intranet Documentation System request form will be
kept for an indefinite period after submitting to the manager documentation.
tabular Presentation of Quality records
s. no.
document type
responsibility
duration
1.
Batch records and analytical reports
QC
Shelf life +2 years
2.
Validation records
Validation
Indefinite
3.
Product specification (Standard control
procedure (SCP)) and STMs
QC/R&D
For 7 years after revision
4.
Prescribing and patient information
Drug information
department
For 7 years
5.
Adverse drug event records
Regulatory affairs/
drug information
Indefinite
6.
Product development record (product file)
(design control)
R&D
Indefinite
7.
Calibration record of the equipment
Maintenance and
calibration
2 years
8.
Test method validation reports
R&D
Indefinite
9.
Stability records
R&D
Indefinite
10.
Product package/technical
Regulatory affairs
Indefinite
11.
Purchase requisition
QA/QC/R&D
6 months after receipt of requested item
12.
Technical package
RM
Indefinite
13.
Temperature and humidity records of file
sample room
QC
1 year
14.
Management review
QA
Indefinite
15.
Handling of nonconformities
QC
Shelf life +1 year
16.
Customer complaints
QA
Indefinite
17.
Purchasing requisition
Purchase
2 years
18.
Approved vendors list
QC
Indefinite
19.
Temperature monitoring records (batch file)
QC
Shelf life +1 year
20.
Training records
QA
Indefinite
21.
Servicing (trouble shooting)
R&D
Indefinite
22.
Internal audits
QA
Indefinite
23.
Transmission request form
Website
Indefinite
24.
New drug application (NDA) and abbreviated
new drug application (ANDA) files submission
QA
Indefinite
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