Specifications and Acceptable Quality Level of Amber Glass Bottles
(USP type III) Supplied by Shandong Pharmaceutical Glass Co., Ltd[SPG].
GENERAL CONDITIONS
1. DEFINITION
The purpose of this document is to describe the quality limits of the supply
agreement/contract to make the Customer– Supplier (Manufacturer and Distributor) relationship
easier. The minimum levels of quality that the Customer can accept are described together with
the control methods which the Supplier has to perform in order to guarantee them.
2. VIAL DEscriptION
This document mainly describes the minimum quality levels of defects acceptable by the
Customer referring to amber glass bottles suitable for the packaging of the following
pharmaceutical products:
• LIQUID SYRUP.
• POWDER for ORAL PREPARATION.
3. RESPONSIBILITY
The controls that the Supplier carries out to guarantee a quality level in conformity with
the details described in this document do not relieve the Customer of its own responsibility in its
pharmaceutical products. On the other hand, the Supplier commits itself to constantly improve
its manufacturing process in regard to quality control and the relevant product certifications.
4. AUDITS
The two parties may agree on a reciprocal AUDIT procedure:
• Customer’s audit of the Supplier’s Quality System.
• The Supplier’s audit at the Customer’s plant in case it is necessary to be aware of the
Customer’s processing and of the relevant characteristics of the concerned products.
5. VALIDITY / ACCEPTANCE
This document, undersigned by both parties, the Customer and Supplier, is considered
to be automatically renewed without time limits. In the future, some modifications can be made
in this document following official request by one of the two parties. Every change, approved by
both Parties, represents a document Revision, and it will be marked by a new Revision
Reference.
6. CONFIDENTIALITY
This document is a property of the Supplier. The information herein has to be
considered as highly confidential. Consequently, the Customer commits itself not to share
information with other parties without the supplier’s agreement.
GENERAL FEATURES
1. CHEMICAL AND PHYSICAL PROPERTIES
1.1 Hydrolytic Resistance
The containers manufactured by SPG in soda-lime silica glass of type III have to comply
with the limits required by U.S.P (Last Edition) and E.P (Last Edition). The non – respect of such
limits amounts to a Super Critical Defect (A.Q.L= 0).
1.2 Light Transmission (for amber glass)
The amber glass container has to range within the light transmission limits (does not
exceed 10% at any wavelength in the range from 290 to 450nm) set by the U.S.P (last edition).
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The non–respect of such limits amounts to a Super Critical Defect (A.Q.L=0).
1.3 Thermal Shock Resistance
The Thermal Shock Resistance limits are defined by SPG according to the item and are
inspected following the methods provided by ISO 7459. The non – respect of such limits
amounts to a Major Defect. (Withstand the thermal shock produced by a temperature difference
of 42℃).
1.4 Axial Load Resistance
The Axial Load Resistance limits are defined by SPG according to the item and are
inspected following the methods provided by ISO 8113. The non – respect of such limits
amounts to a Major Defect.
1.5 Residual stress
Choosing a suitable quantity of the products to test them according to the testing
method of glass container(ISO7458). The discrepancy of the light gap shouldn’t overpass
40nm/mm.
1.6 The Extractable Arsenic, Antimony, Lead, Cadmium that Released:
Taking suitable quantities of the vials to make a test according to the test method of
SFDA norm No. YBB00172005 <<Method for determination of As, Sb, Pb, Cd>>. The
limitations should be: As≤0.1mg/L; Sb≤0.7mg/L; Pb≤1.0mg/L. Cd≤0.25mg/L. The results of
analyses for extractable As according to Arsenic Test-A in USP<660><211> and Arsenic Test-B
in Ph. Eur 3.2.1 are less than 0.1ppm. We certify that Arsenic is not intentionally added as
components in the batch composition with which we manufacture our glass for containers.
2. TECHNICAL DRAWINGS
The specifications have to be accompanied by Technical Drawing of the concerned item
approved by the Customer. For every change in the dimensions or/ and features, either
required by the Customer or proposed by the Supplier, a new Technical Drawing will be issued
to replace the previous one, and the Customer will have to approve it again. The Technical
Drawing presents the following indications:
• Product name or description
• Product code
• Dimensions
• Brimful capacity
• Date and approval signature
3. PACKAGING
The specifications have to be accompanied by Packaging Form presenting the packaging
features. Mainly:
• Number of pieces per packaging unit (pack, tray, etc.)
• Item lay – out on the layer or in the packaging unit
• Dimensions and weight of the packaging unit
4. LABEL AND TRACEABILITY
Labels indication useful data concerning the packaged product are affixed on every pack:
• Product name or description
• Product code
• Batch number
• Manufacturing date
• Quantity
• Manufacturer’s name
• Customer’s name (in case of private item)
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5. BATCH DEFINITION
During the Delivery phase the Batch is represented by the date corresponding to a
delivery.
DEFECTS DEFINITION
1. CRITICAL DEFECTS
These types of defects may damage the user both due to direct causes (directly caused
by the container) and indirect causes (for ex. bad product preservation).
2. MAJOR DEFECTS
These types of defects may cause a bad functioning of the production lines even to their
total stop.
3. MINOR DEFECTS
These types of defects may reduce the general quality and line performance, still
without implying risks for the usability of the product for its intended purpose. Some defects are
typically esthetical.
STATISTIC INSPECTION
1. ACCEPTANCE SAMPLING
The sample used for the acceptance controls will represent the whole batch. A random
selection of the sample is thus carried out on various points of the charge in order to respect
the batch homogeneity following the table below:
SAMPLING TABLE
PACKS PACKS TO BE
PER BATCH INSPECTED
0 -25 5
26 – 36 6
37 – 49 7
50 – 64 8
65 – 81 9
82 – 100 10
N > 100 SQR (N)
The damaged pallets will not be part of the statistic sampling; on the contrary they will
be put aside and separately sampled.
The sample dimensions and the criteria to be followed for acceptance of the batch or
refusal are those described in the Military Standard 105E:
Level I General Inspection for normal inspections (Table 1)
TABLE 1: LEVEL I GENERAL INSPECTION
BATCH SIZE SAMPLING
SIZE
A.Q.L.
0.065
A.Q.L.
0.25
A.Q.L.
0.40
A.Q.L.
0.65
A.Q.L.
1.0
A.Q.L.
1.5
A.Q.L
4.0
PCS PCS A R A R A R A R A R A R A R
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3,201 / 10,000 200 0 1 1 2 2 3 3 4 5 6 7 8 14 15
10,001 / 35,000 315
0 1 2 3 3 4 5 6 7 8 10 11 21 22
35,001 / 150,000 500 0 1 3 4 5 6 7 8 10 11 14 15 21 22
150,001 /
500,000
800 1 2 5 6 7 8 10 11 14 15 21 22 21 22
> 500,000 1,250 2 3 7 8 10 11 14 15 21 22 21 22 21 22
DIMENSION PART APPEARANCE PART
CRITICAL DEFECTS: AQL=0.10 AQL=0.10
Over upper limit of Total Height(higher by 0.3mm
more) Insects in the Bottle
Over upper limit of OD of Body(higher by 0.3mm
more) Foreign bottles in the same packaging
Over upper limit of OD of Finish(higher by 0.3mm
more) Special shaped Bottles
Less under limit of OD of Finish(lower by 0.3mm
more) Birdswing
Over upper limit of OD of Screw(higher by 0.3mm
more) Color line
Less under limit of OD of Screw(lower by 0.3mm
more) Broken Bottle
Over upper limit of OD of Skirt(higher by 0.3mm
more) Bottle with crack
Less under limit of OD of Skirt(lower by 0.3mm more) Bubble , ≥ 5mm
Ultra uneven bottom (deformed bottom causes the
height difference, 100ml down over than 0.5mm,
101ml-149ml over than 0.6mm, 150ml up over than
0.7mm.
Stuck Ware, ≥10mm
Stone, ≥ 2mm
Crack (checks), ≥ 10mm
Unfilled finish
MAJOR DEFECTS A : AQL=0.65 MAJOR DEFECTS : AQL=0.40
Vertical axle deviation 2mm<Crack<5mm
ID OF Neck 1mm≤Stone<3mm
uneven bottom 3mm≤Bubble<5mm
Residual stress Color Spot
MAJOR DEFECTS B : AQL=1.0 MINOR DEFECTS A: AQL=0.65
OD of Finish Soft blisters, < 5mm
Total Height
ID of Finish MINOR DEFECTS B : AQL=1.0
OD of Screw Chechs, ≤2mm
OD of Body 1mm≤bubble<3mm
OD of Skirt Stone, <1mm
Thickness of Bottom Mould Seam line
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Height of finish
Thermal Shock Resistance
MINOR DEFECTS: AQL=1.5 MINOR DEFECTS C : AQL=1.5
OD of Neck bubble, <1mm
Thickness of Bottom
Oval Body
2. INSPECTION PROCEDURES DURING ACCEPTANCE
once the sampling has been carried out in conformity with the tables 1, the samples
presenting defects are identified and classified according to the above described classes. In
case a sample presents various defects only the major defect will be considered.
Two different situations may occur:
• The number of defects is equal or lower than the acceptance number: the
Batch is accepted.
• The number of defects is equal or bigger than the refusal number: the
Batch is rejected.
3. COMPLAINTS
This document presents the rejection or acceptance procedures concerning the defected
batches. The Customer has to inform the Supplier of the found defects by putting forward a
quality report which included inspection / test method and data.
The complaint has to forward to the Supplier by FAX or EMAIL and the samples deemed as
defective must be sent to the Supplier as soon as possible.
The claims will be accepted only if accompanied by all of the required data.
3.1 DEFECTS DETECTED AT THE RECEPTION
Procedure to be used in case of defects retrieved by inspections carried out at the goods
reception.
3.1.1. ACCEPTANCE
In case the total number of defective samples is lower than the refusal limit value, the
Customer may inform the Supplier that the batch has been accepted.
In case the number of defective samples detected on a batch is higher than the A.Q.L,
but the Customer considers the defects influence on its packaging process and on its market
image being not too serious, the Customer may exceptionally accept the batch with reservation
of testing it.
3.1.2. REJECTION
In case the delivered goods do not comply with the Specifications rules they will be
refused and a claim put forward to the Supplier.
The Supplier reserves the right to perform a cross – inspection.
TWO POSSIBLE SOLUTIONS EXIST
1) The Supplier withdraws the defective goods and replaces them according to the Customer’s
request.
2) On site sorting of the defective goods (The Supplier may authorize this procedure only in
case of emergency) following the conditions below:
-To submit an estimate of the sorting cost to the Supplier.
-To carry out the sorting after obtaining a written authorization from the Supplier
-To send the relevant invoice to the Supplier.
3.2 DEFECTS DETECTED ON THE PRODUCTION/ FILLING LINES
In case a batch, although having passed the acceptance inspections, presents the
following functional defects: OD or/and ID of Finish, Total height, Oval Body, Verticality,
- 6 - Thermal Shock and Internal Pressure Resistance, when being used. The buyer and supplier
should negotiate the settlement.
Approved & Signed by: Approved & Signed by:
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Date: Date:
On behalf of On behalf of Shandong Pharmaceutical Glass Co., Ltd.