DIFFERENT
TYPES OF PROTOCOL SHEET
(WORK SHEET) for
Finished Products
Raw Materials
Intermediates
Bulk
Packaging materials
Finished products (sterile)
indicating all tests to be performed as per the pharmacopoeia,
the in-house specifications
the Drugs and Cosmetics Act
and the Rules,
FDA and formats for entering readings /
observations.
Facility for user-defined protocol sheet.
SAMPLING SHEET
CERTIFICATE OF
ANALYSIS for
Finished Products
Raw
Materials
Intermediates
Bulk
Packaging
materials
(all sample category wise)
Retest samples
R & D samples
Pre-purchase samples
Pre-shipment
samples
Stability samples
|
 |
|
LABELS
Under Test Label
Approved Label
Rejected Label
Quarantined
Released
In process
etc... |
|
REGISTERS
Sample registers - product category wise - date
wise / analytical report number wise
Rejection
Register
REPORTS FOR MIS
Quality Control Productivity Report
Analyst Performance Report
Certificates Pending for
Printing
Samples Pending for Analysis
Samples
Pending for Sampling
Lab Performance
Sample
Status report
Samples For Retest
Products For
Destruction
Fiducial limits of error
Deviation
from in-house specifications (OOS)
DOCUMENTS
Finished Products Specifications
Raw Materials
Specifications
Standard Operating Procedures
Standard Testing Procedures
Manufacturing procedures |
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