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1.2 Product specifications indicate dosage form (e.g. tablet, liquid, injectable, emulsion,
suspension etc.) and the drug content (exact number of mg. or percentage v/v with
acceptable range). The products should conform to standards specified in one of the
following compendia: Indian Pharmacopoeia the British Pharmacopoeia, the United
States Pharmacopoeia, the French VIPAL Pharmacopoeia or the International
Pharmacopoeia. In case the pharmaceutical or vaccine is not included in the specified
compendium, the Supplier, upon award of the contract, must provide the reference
standards and testing protocols to allow for quality control testing.
1.3 Not only the pharmaceuticals or vaccine items, but also the packaging components
(e.g. bottles and closures) should also conform to specifications suitable for use in a
climate similar to that prevailing in the country of the Purchaser. All packaging must
be properly sealed and tamper-proof.
1.4 Pharmaceuticals and vaccines requiring refrigeration or freezing for stability must
specifically indicate storage requirements on labels and containers and be shipped in
the special containers to ensure stability in transit from point of shipment to the port
of entry.
2 Product information
2.1 The following information will be required for each pharmaceutical and vaccine
product offered by the Bidder:
2.2 Upon award, the supplier shall on demand provide a translated version in the
language of the Bid of the prescriber’s information for any specific product the
Purchaser may request.
2.3 Failureto include any of this information, at the discretion of the Purchaser, render
the Bid non-responsive.
Section VII – Technical Specifications 82
3 Expiration date
3.1 All products must indicate the dates of manufacture and expiry. In addition, unless
otherwise stated in Part A of these Specifications, all products must arrive at the port
of entry (for imported pharmaceuticals and vaccines) or consignees’ warehouse (for
local purchases) with a remaining shelf life of at least five-sixths (5/6ths) of the total
stipulated shelf life at the time of manufacture.
i) Rifampicin : shelf life should not be less than 32 months from the date of
manufacture.
ii) INH (Isoniazid) : shelf life should not be less than 56 months from the date of
manufacture.
iii) Ethambutol : shelf life should not be less than 56 months from the date of
manufacture.
iv) Pyrazinamide : shelf life should not be less than 56 months from the date of
manufacture.
v) Tab Pyridoxine (Vitamin B6) : shelf life should not be less than 32 months
from the date of manufacture.
For combipacks, the shelf life shall be the same as that of Rifampicin being the
constituent of combipack with the shortest shelf life.
4 Recalls
4.1 If products must be recalled because of problems with product quality or adverse
reactions to the pharmaceutical or vaccine, the Supplier will be obligated to notify the
purchaser providing full details about the reason leading to the recall and shall take
steps to replace the product in question at its own cost with a fresh batch of acceptable
pharmaceuticals or vaccines, or withdraw and give a full refund if the product has
been taken off the market due to safety problems.
5. Labeling instructions:
5.1 The label for each pharmaceutical and vaccine products shall meet the W210 GMP
standard and include:
i) the INN or generic name prominently displayed and above the brand name,
where a brand name has been given. Brand names should not be bolder or
larger than the generic name;
ii) the active ingredient “per unit dose, tablet or capsule, etc.;
5.1 The outer carton should also display the above information.
No case should contain pharmaceutical or vaccine products from more than one
batch.
7. Unique identifiers
7.1 The Purchaser shall have the right to request the Supplier to imprint a logo on the
containers used for packaging and in certain dosage forms such as tablets and this will
be indicated in Part A of the Technical Specifications. The design of such logo shall
be provided to the Supplier at the time of Contract award.
8. Qualifications of manufacturer:
The Bidder shall furnish a certificate from the competent FDRA (Form 5) that the
manufacturer of the pharmaceutical or vaccine product covered by this Invitation for
Bid is licensed to manufacture these products.
d) evidence of basis for expiration dating and other stability data concerning the
commercial final package upon request.
9.3 The successful Bidder will also be required to provide the Purchaser with access to
its manufacturing facilities to inspect its facilities, quality control procedures for raw
materials, test methods, in-process tests, and finished dosage forms.
(i) The blister is TROPICIALIZED with moisture barrier properties for drug
stability under field condition.
(iv) Spacing between tablets allowing removal by patients with finger deformities.
(vi) Outside box label with health worker instructions, if any, colour coded to
match contents.
(viii) The pharmaceuticals under Product Codes 13, 14, 15 & 16 will be supplied
duly packed in blister combi-packs which thereafter would be packed in
laminated pouches. These pouches would further be packed in millboard/
greyboard boxes and ultimately these would be put in 5-ply shippers for
dispatch.
Section VII – Technical Specifications 85
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX Polyethylene
XXXXXXXXXXXXXXXXX
Polyvinylidenechloride compound with
particularly high water vapour barrier
Complex:
Thermoformed:
Not thermoformed:
Shrinkage longitudinally
(b) Laminated Pouch Two pouches will be required for each category of
treatment as specified in the schedule of requirement.
Each pouch will be labelled in Yellow colour as per
details given under para 9.4.5.1 – labels.
Box: Each box will contain the combi-blister packs for one
patient and labelled in Yellow colour as given under para
9.4.5.1 – Labels.
Description: RSC (Universal) type, 5-ply corrugated box made in narrow flute from
(150)5 gsm, virgin quality ‘A’ grade kraft paper.
Section VII – Technical Specifications 87
The configuration of the different drugs in the blister strips will be as indicated
under para 9.4.4.3 and 9.4.4.4 – Configurations.
(b) Laminated Pouch Two pouches will be required for each category of
treatment as specified in the schedule of requirements.
Each pouch will contain the blister combi-packs strips
and labelled in Orange colour as per details given under
para 9.4.5.2 – Labels.
(c) Millboard/Greyboard
Box: Each box will contain the combi-blister packs for one
patient and labelled in Orange colour as per details given
under para 9.4.5.2– Labels.
The configuration of the drugs in the blister combi-pack will be as indicated under
para 9.4.4.1 – Configurations
(b) Laminated Pouch One extra month supply of schedule 5 drug in pouches,
each pouch containing 12 blister combi-packs. Each
pouch will be labelled in Pink colour as per details
given under para 9.4.5.3– labels.
Description: RSC (Universal) type, 5-ply corrugated box made in narrow flute from
(150)5 gsm, virgin quality ‘A’ grade kraft paper.
Section VII – Technical Specifications 89
9.4.3.4 Product Code-16 Treatment box for prolongation of intensive phase of pediatric
cases (18-25 kg and 26-30kg)
Aluminum Foil: 0.025 mm, VMCH coated Orange colour Aluminum foil
printed as per approved art
The configuration of the drugs in the blister strips will be as indicated under para
9.4.4.3 – Configurations.
(c) Laminated Pouch One extra month supply of schedule 7 drug in pouches,
each pouch containing 12 blister combi-packs. Each
pouch will contain the blister combi-packs strips and
labelled in Grey colour as per details given under para
9.4.5.4– Labels.
(c) Millboard/Greyboard
9.4.4 CONFIGURATIONS
“RNTCP SUPPLY
CGS – NOT FOR SALE”
R H
Z E
Batch No.
Mfg Date
Exp.Date
Section VII – Technical Specifications 91
“RNTCP SUPPLY
CGS – NOT FOR SALE”
Day 1
R H
Day 2
X
Day 3
R H
Day 4
Day 6
Day 7
X
Section VII – Technical Specifications 92
“RNTCP SUPPLY
CGS – NOT FOR SALE”
R H
Z E
Batch No.
Mfg Date
Exp.Date
Section VII – Technical Specifications 93
“RNTCP SUPPLY
CGS – NOT FOR SALE”
Day 1
R H
Day 2
X
Day 3
R H
Day 4
Day 6
Day 7
X
Section VII – Technical Specifications 94
9.4.5 Label Text for Laminated Pouch, Millboard Boxes and 5-Ply Shippers
LAMINATED POUCH
Batch Nos:
Batch Nos:
Mfg Date:
Mfg Date:
Expiry Date:
Expiry Date:
Z E H R H R X
Z E H R X
Batch Nos:
Mfg. Date:
Exp. Date:
“RNTCP– Central Government Supply
Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 97
LAMINATED POUCH
Batch Nos:
Batch Nos:
Mfg Date:
Mfg Date:
Expiry Date:
Expiry Date:
Z E H R X
Batch No. :
Mfg. Date:
Exp. Date:
“RNTCP - Central Government Supply
– Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 100
LAMINATED POUCH
Z E H R
Batch No:
Mfg Date :
Expiry Date:
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 101
Z E H R
Batch Nos:
Mfg. Date:
Exp. Date:
“RNTCP - Central Government Supply
Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 102
Z E H R X
Batch No. :
Mfg. Date:
Exp. Date:
“RNTCP - Central Government Supply
– Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 103
LAMINATED POUCH
Z E H R
Batch Nos:
Mfg Date :
Expiry Date:
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 104
Z E H R
Batch Nos:
Mfg. Date:
Exp. Date:
“RNTCP – Central Government Supply
– Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 105
Z E H R X
Batch No. :
Mfg. Date:
Exp. Date:
“RNTCP - Central Government Supply
– Not for Sale”
Manufacturer’s Name
Manufacturing Lic. No.
Section VII – Technical Specifications 106
Laminated Pouch
Section VII – Technical Specifications 107
5 – Ply Shipper