1. INTERPORT LIMITED QOP 0000
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QUALITY OPERATING PROCEDURE
Down Stairs QC
1. Introduction
To ensure that Parallel Imported Pharmaceutical (P.I’S)are
Inspected by QC and approved for use prior to
relabeling/repacking.
2. Scope
To manage and control the inspection of Pharmaceutical products
through the first stage of QC inspection.
3. RelatedDocuments
BS EN ISO 9001: 2008 Requirements 7.4, 7.5.3
SOP QC003-14
SOP QC004-09
SOP W001
Company Quality Manual
4. Responsibilities
QC staff is responsible for Inspecting & Processing of
pharmaceutical products through to approval.
5. Procedure for Processing & Inspecting of Pharmaceutical
Product, Stage One Works order Processing.
5.1 Sample of the product(Retained Sample) is given to down stairs
QC, they will check the productagainst the GRN, Invoice
& Receipt Note (Three documents Attachment 14, 11 & 17).
Most of the Master Batch Sheets will be held in files
5.2 Most of the Master Batch Sheets will be held in files in down
stairs QC, but if not QC will ask for the BPR for the relevant
productfrom Up-stairs QC. Down stairs QC will then
check the productdetails against the details on the batch sheet.

2. INTERPORT LIMITED QOP 0000
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these are: Strength of the product, Interports Batch No,
expiry of product, lot No, qty and pack size. Pack size
information will be supplied by Commercial Director via Email
(Sweden Only). Batch sheet (Attachment 1)
5.3 Only the following sections of the BPR will be completed
by Stage one QC, GRN No, date required, Interports batch No,
qty received, manufacturer, batch No (lot No), productname,
Strength, MA Holder & country of origin.
5.4 Once the batch sheet is completed then a works order will be
produced via SAGE. Works order (attachment 18)
5.5 Passed to QC officers for next stage of processing.
6.0 QC Officer will Inspect & Processto Final Stage.
6.1 Retained sample with the following documents will be passed to
the QC Officer, Batch Packing Record Sheet & Works
Order (attachments 1 & 18) Note, for EMA Products Country of
Origin will be added by the QC Officer with a pen.
6.2 The QC Officer will check the information on the BPR, name and
reference No of the productand obtain the sample productfrom the
Reference Sample ProductDraws (note, all product draws are
identified with a number and all reference productmust have a
sticker on the box with a reference number on it). The QC Officer
will check the Reference Sample Product against the BPR and
against the RetainedSample Product, making sure all details are
the same. This includes the box colour size and features. The other
checks are the strength of the product, name, & EMCA No.
The productout carton is opened and the productis checked in the
same way, the leaflet is also checked against the Reference Sample
Leaflet which is with the Reference Sample Product. Note that a
pen mark should be applied to the RetainedSample leafletto
make sure they are not mixed-up.
The following checks will take place, MA Holder, Manufacturer
and the country of origin. Other checks can be performed to make

3. INTERPORT LIMITED QOP 0000
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sure the leaflets are identical, e.g. ingredients.
6.3 The QC Officer will check that Retained Sample ProductLeaflets is
Identical to the batch sheet, batch sheet (Leaflet) will always be in
English. ( language may be different on the leaflet). Check various
aspect of the leaflet for common themes, size of leaflet,
manufacturer must be on the leaflet & and the ingredients.
6.4 If all the above is correct add the reference sample number to the
batch sheet (e.g. R1196/5). One final check of the details and then
sign off approved by QC Officer and update SAGE and the works
order
7. 0 Records
Copyof the approved suppliers List is kept in GoodsIn
(updated by RP on a monthly basis)
GoodsIn Book Kept for 5 Years
Work Station Log kept for 5 years

4. INTERPORT LIMITED QOP 0000
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Down Stairs QC Department Process Flow Chart
Goods In Supervisor gives
Retained Sample and
documents, e.g. GRN, Invoice
& Receipt Note (attachments
14, 11 & 17.
To Down Stairs QC
First stage QC will pass the Retained Product and the following
documents,works order & BPI.
First Stage Down-stairs QC will ask for BPR from
Upstairs QC.
If BPR is available then move onto the next
process
Once BPI is available Stage one QC will process the batch using
Sage and check various aspects ofthe product and BPI.
For Sweden only, the pack size information will be supplied by
the Commercial Director.
Relevant Reference Sample Product will
selected from storage area.
.
Commercial Director supplies the
relevant information
Pre-production area will process the Batch,
Retained Sample Product will stay with the
batch all the way through the production
process.
QC Officer will Check and start processing the Retained
Product, and will obtain the Reference Product.
The QC Officer will carry out checks using the Reference Sample
Product against the Retained Sample Product and complete all
document required and update Sage Computer System. Reference
Sample Product goes back to Reference Sample storage area.
Completed Retained Sample Product with relevant Documents, this
may include BPI, works order & in-process checklist
Up-stair QC will supply the relevant BPR