Biomedical Engineering Reference
In-Depth Information
48.5
attachment forms
abc Pharmaceutical comPany
Annexure-I
SOP No.: QAS-
Issued on:
Revision No.:
Initiator name:
TECHNICAL DOCUMENTS TRAINING RECORD
i. Manufacturing formula and method
vii. Raw materials specifications
ii. Finished production specifications (FPS)
viii. Test method validation report
iii. Standard test method (STM)
ix. Registration documents
iv. Stability report
x. In-process control specification (mfg. and pack)
v. Master packaging instruction (MPI)
xi. Raw material purchasing specification
vi. Packaging material specifications
xii. Packaging material purchase specification
signature of
understanding
training conducted
by
signature of the
trainer
trainees (name)
id no.
date
evaluation
results
Evaluation:
O = oral
Results:
M = marginal (re-train required)
R = written
A = average
Q = questionnaire
S = satisfactory
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