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Presented By,
Sunil Sawant (M.Pharm, MBA)

 Every where: e.g.
 Warehouse • H.R.Dept
 Manufacturing • Regulatory Affairs
 In process • R & D
 Packaging
 Quality control
 Engineering
 Quality Assurance

 Intradepartmental review
• Online review (Prevention)
• Offline review (Remedy)
Ratio: 3:1
Interdepartmental review
• Online review (Prevention)
• Offline review (Remedy)
Ratio: 1:3

In Manufacturing Area:
 General hygiene & cleanliness
 Environmental conditions
 Batch manufacturing / packing records
 In process checks
 Adherence to SOPs & procedures
 Log book entries
 Equipment Instrument status & calibration
validity

In Ware house:
 General hygiene & cleanliness
 Quarantine area
 Sampling area
 Release stores
 Status labels on the containers
 Equipment Instrument status & calibration validity

In Quality Control:
 General hygiene, cleanliness & house keeping
 Status labels on glass wares & instruments
 Equipment Instrument status & calibration validity
 Note books
 Data hard copies & soft copies

In Quality Assurance:
 Assurance of online review
wherever applicable
 Document issuance
 Document receipt

 Batch manufacturing record
 Batch packing record
 Calibration reports & records
 Notebooks
 Data hard copies & soft copy review

 Training needs
 Training
 Effectiveness of training
 Minimum person to person variations of
concepts, interpretations & skills
 Right person on right job
 Individual efficacy

 Always refer relevant reference documents.
 Increase online review than offline.
 Increase online training of the performer.
 Follow relevant sops meticulously.
E.G. Good documentation practices, note
book entries, good chromatographic practices,
OOS, OOE, deviation etc.

 Never compare more than two documents at a
time i.e. if there is a requirement to compare
single document against multiple of reference
documents then compare it only against one
document at a time
 Sequentially review document for comparison
with reference, data transcription, fulfillment of
acceptance criteria & finally presentation.

Online review:
 Can be prevented
 If occurrence is
found, then can
easily be remedied
 Less investigation is
required
 Investigation
becomes more
effective
Offline review:
 Can be remedied
 Remedy may be
easy or may be
complicated
 More investigation is
required
 Investigation may
not be as effective
as in case of online
review

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